Management of bile duct stones.

SEMINARS IN LIVER DISEASE-VOL.

10, NO. 3, 1990

Management of Bile Duct Stones

The management of bile duct stones has been evolving over the past 15 years. Prior to that time, abdominal exploration with choledochotomy was the main therapeutic recourse for the patient with common duct stones. Currently available alternative therapies' (Table I) allow the physician to select the most appropriate therapy for a given patient. Paralleling the development of alternative therapies has been the advent of improved methods to detect the presence of common duct stones (examples: endoscopic retrograde cholangiopancreatography

TABLE 1. Management Alternatives for Bile Duct Stones Irrigation (via T-tube) Extraction ERCP-sphincteroto~~iy Percutaneous T-tube Transhepatic Surgical duct exploration Stenting Temporary Nasobiliary catheter Percutaneous Long-term Internal stent Fragmentation (lithotripsy) Basket crushing (mechanical) Laser Pulsed dye '! best via Q switched mother-daughter system Electrohydraulic Extracorporeal shock waves Dissolution Oral agents Ursodeoxycholic acid (Actigall"") Chenodeoxcholic acid (Chenixob) Transcatheter Monoctanoin (MoctaninW) Methyl tert-butyl ether Calcium solubolizing agents (e.g.. EDTA) Observation only

I

From rhe Division of Ga.strornrerologyiHep~~foIogy, Indicmci Univer.sitv School of MedicYne. Reprint address: Dr. Lehman, Department of Medicine, Division of GaatroenterologyiHepatoIogy,Indiana University School of Medicine, Bloomington, IN 47014.

(ERCP), percutaneous transhepatic cholangiography (PTC), computed tomography (CT) scan and ultrasound). In this review, we will examine the methods to diagnose choledocholithiasis and the techniques available for the successful removal of stones. Treatment methods that are well established and whose techniques have not changed significantly in recent years (surgery, ERCPsphincterotomy, T-tube tract extraction) will be covered more concisely, whereas new techniques will be reviewed more thoroughly.

NATURAL HISTORY OF CHOLEDOCHOLITHIASIS Common bile duct stones can be classified into two types. Primary stones are formed directly in the bile duct' and are composed predominantly of calcium bilirubinate with variable amounts of cholesterol or fatty acid. Their pathogenesis appears to depend on the presence of biliary stasis (example, stricture) and bacterial infection.'.-' In contrast, secondary stones reflect the composition of gallbladder stones (predominantly cholesterol in 80% and black pigment in 20%) and are therefore believed to be of gallbladder origin'.' i.e., stones are formed initially in the gallbladder and migrate into the ductal system. These differences in composition may affect their response to therapy. For example, primary stones will not dissolve in lipid solvents. About 15% of patients with cholelithiasis will have choledocholithiasis at the time of surgery. Conversely, of the patients with ductal stones, 95% also have concomitant gallbladder stones.' The cystic duct diameter appears to be an important determinant in stone migration into the common bile duct. In a prospective study, Taylor and Armstrong7 evaluated 331 patients undergoing cholecystectomy. It was found that stones present in the gallbladder could be squeezed through the length of the cystic duct in 60% of patients with common bile duct stones, 67% with gallstone pancreatitis, but only 3% of those with gallbladder stones alone. None of the gallbladder stones with diameters greater than the cystic duct could be forced through it. Of course, large gallstones unable to traverse the cystic duct may enter the common duct through a fistula. The natural history of choledocholithiasis is variable. It is clear that there is a subpopulation of patients

Copyright 0 1990 by Thieme Medical Publishers. Inc., 381 Park Avenue South, New York. NY 10016. All rights reserved.

205

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STUART SHERMAN, M.D., ROBERT H. HAWES, M.D., and GLEN A. LEHMAN, M.D.

SEMINARS IN LIVER DISEASE-VOLUME

who remain asymptomatic for months to years."n an autopsy series, 142 of 615 (23%) patients older than 60 years had cholelithiasis and Inore than half had asymptomatic common duct stones." Simil;lrly, in another autopsy series, 24% of patients with cholelithiasis had common duct stones but never came to clinical attention."' Millbourn" reported on 38 patients with choledocholithiasis who were followed without operation either because they refused surgery or were believed to be surgically unfit. During the follow-up period of 6 months to 13 years. 17 (45%) patients had nc further symptoms. whereas the remaining 21 had one or more episodes of colic, jaundice, or cholangitis. Common bile duct stones may also pass into the duodenum and be evacuated in the stool without producing symptoms. In one series. stones were recovered in the stool in 11% of patients with asymptomatic cholelithiasis." A second subpopulation of patients manifest symptom:; directly related to choledocholithiasis as their first sign of gallstone disease." This group often presents a therapeutic dilemma. Although most agree that endoscopic sphincterotomy (ES) is the initial procedure of choice for common bile duct stones in high-risk surgical patients with an intact gallbladder, the management of the average risk patient is controversial." A final group of patients will have symptomatic choledocholithiasis days to years after cholecystectomy. Despite technical advances (examples, intraoperative cholangiography. ultrasonography, and choledochoscopy) retained calculi can be expected to occur in 5 to 15% of patients following common duct exploration.li It may be impossible to determine whether the present stones were overlooked at the earlier operation or have formed since.'" The longer the time interval from cholecystectomy and common bile duct exploration, the more likely the stones are newly formed. It is reasonable to conclude, based on the pathogene:iis and composition of primary and secondary common bile duct stones, that cholesterol and black pigment stone:; usually have been overlooked. Calcium bilirubinate stones also could have been missed; however, if cholestasi:; and bactobilia are present, it is more likely that the stone (calcium bilirubinate) is new." It is estimated that more than 75% of patients with choledocholithiasis will ultimately become symptomatic. The incidence of common d ~ . c tstones increases with age (similarly with gallbladder :;tones) and duration of gallstone disease, suggesting that migration of gallstones into the common duct is time-dependent.'x To summarize, choledocholithi;~sisusually (but not always) results from passage of gallstones into the common duct. Bile duct calculi ultimately become symptomatic in the majority, but a significant proportion will never manifest symptoms. It is most commonly a disease of older patients, often presenting with complications as the first evidence of calculus diseaie. Important questions in the natural history of common duct stones remain unanswered. When and which patients will become symptomatic? What are the inciting factors to stone migration? What is the clinical course of patients in whom common duct stones are left behind at the time of operation'? Answers to these questions may allow us to direct our therapy before complications develop.

TABLE 2.

10, NUMBER 3, 1990

Complications of Choledocholithiasis

Pancrcatitis Cholansiti\ with or w ~ t h o u tsepsls Chole\tasi\ Liver abscc\\ Secondary biliary cirrhosis Iluct strictures

CLINICAL MANIFESTATIONS Patients with choledocholithiasis may be asymptomatic. More commonly they will present with one or more of the following clinical manifestations: biliary colic, jaundice, cholangitis, or pancreatitis" (Table 2). The exact relationship between gallstones and pancreatitis remains an issue of contention. The bile reflux theory proposes that obstruction of the papilla leads to retrograde flow of bile into the pancreatic duct. Infected bile and, perhaps, bile under high pressure can activate pancreatic enzymes resulting in pancreatitis.'" Proponents of the common channel theory state that ampullary obstruction by a stone blocks the pancreatic duct, resulting in pancreatitis.'? Anatomic features of the pancreatic duct'" and stone characteristics (stones less than 3 mm are frequently associated with pancreatitis)" appear to be important modifying influences. Cholangitis results from biliary tract obstruction with secondary infection. High intraductal pressure seems to be a prerequisite for cholangitis as attempts to infect unobstructed ducts have been u n s u ~ c e s s f u l . ~ ? . ? ~ The clinical features of cholangitis are variable, though fever" and right upper quadrant pain" are seen in more than 90%. Jaundice is present in up to 80% of patients and correlates both with duration of obstruction and mortality." Signs of sepsis and central nervous system (CNS) depression are seen in 10% of patients. Charcot's triad (right upper quadrant pain, jaundice, and fever) is seen in 50 to 70% of cases.'5 Several authors caution that elderly patients may not be febrile or complain of pain.24.?5.27 Positive bile cultures are found in most cases with bacteremia present in 25 to 40%.'%iver abscess is a rare consequence of cholangitis. Secondary biliary cirrhosis may result from long-standing biliary tract obstruction. Elderly patients may present with weight loss (with or without jaundice), anorexia, or vague abdominal complaints suggesting an intra-abdominal malignan~y.'~

LABORATORY FINDINGS Hepatic and pancreatic chemistries may be normal in patients with nonobstructing common bile duct stones.' In assessing the biochemical features of 100 consecutive symptomatic patients during the first 3 days of their illness, at least one abnormality was found in 99%" (Table 3). The most frequent abnormalities were high gamma glutamyl transpeptidase (94%) and alkaline phosphatase (AP, 9 1 %), with aspartate aminotransferase (AST), alanine aminotransferase (ALT), and total bili-


206

MANAGEMENT O F BILE DUCT STONES-SHERMAN.

207

HAWES. LEHMAN

TABLE 3. Levels of Serum Biologic Tests Performed During First Three Days Following Onset of Symptoms of Choledocholithiasis (Mean & SD)*

Leuhocytosis (lO"1Iiter) Total h~liruhtn( N < 17 p m o l l l ~ t e r ) Gamma glutaniyl tran\peptitlase ( N < 35 IUilitcr) Alkaline phosphatase ( N < X O IUlliter) AS?' ( N < 3 0 lullitcr) ALT ( N < 4 5 IUIliter) Amylase ( N < 4 0 IUIliter)

11.27 i 6 . 8 6 0 i 64 372 + 321 265 ? 102 121 i 135 1x3 i 1x0 45 i 38

10.93 t 4 Oh 6X i X5 491 i371 229 i 357 115 i 136 238 2 531 73 i XX

11.18 -t 6 53 66 2 09 105 i 306 255 i 248 120 -+ 135 106 i 305 3X i 55

."Adapted from Anciaux et al.'" Reprinted by perm~ssion. -1-Group 1: 72 patient\ without prior cholecy\tectom).: s r o u p 2: 28 pattent\ with priot- cholecy\tectom)

SPECIAL DIAGNOSTIC TESTS Intravenous cholangiography (IVC), formerly the screening examination of choice for patients with suspected choledocholithiasis, has a low diagnostic accuracy, especially when the bilirubin is greater than 2.5 mgidl, and is associated with serious allergic reactions.j4 The development of improved diagnostic techniques has made IVC rarely necessary. Ultrasound is capable of detecting gallbladder stones and dilated ducts with an accuracy approaching 90%." However, it is able to identify common duct stones, per se, in only 15% of patients This subsequently proved to have choledocholithia~is.~ figure increased to 33% when patients were clinically jaundiced." CT scans are also accurate in detecting biliary dilation but, like ultrasound, are largely unsuccessful in demonstrating common bile duct stones.3xDirect cholangiography by ERCP or PTC are highly accurate in establishing the cause of mechanical jaundice." The choice of which test to perform should be based on the local expertise and facilities. However, ERCP is generally preferable because it offers better associated therapeutic options without peritoneal soilage. ERCP also offers the opportunity to visualize the pancreatic duct.'"." Alternatively, if choledocholithiasis is highly suspected at surgery, an intraoperative cholangiogram can be obtained. Routine use of this technique has been shown to

reduce the number of retained stones and decrease the number of negative common bile duct exploration^.".^'^^

TREATMENT OF COMMON DUCT STONES The presence of a common duct stone is generally an indication for its ren~oval.However, the timing, and in many instances the method, of its removal remains controversial. A spectrum of management options exists (Table I ) , but therapy must be individualized. In general, the greater the patient's risk for con~plicationsand the more unstable he is, the greater the urgency of definitive management.

Endoscopic Techniques Since its inception in 1974. the indications for ERCP and ES have been growing steadilyJi (Table 4). Although controlled studies have not been performed, ES is considered the procedure of choice for choledocholithiasis after cholecystectomy and in poor surgical risk patients with the gallbladder still present.'" Its role as a therapeutic modality (to be discussed later) for the treatment of common bile duct stones in the average risk surgical patient with an intact gallbladder and as a routine procedure prior to cholecystectomy (to avoid common bile duct exploration) remain controversial. This technique uses a side-viewing duodenoscope, a sphincterotome, and electrodiathermy to incise the papilla and the sphincter muscles surrounding the ampulla of Vater and a portion of the sphincter choledochus.'" By enlarging the papillary orifice, a nasobiliary catheter, biliary endoprosthesis, stone-retrieving balloon or basket, or other equipment can be passed into the common duct. The size of the endoscopic sphincterotomy should be tailored to the size of the stone, but most often can be safely extended to I0 to 15 mm in length. The average common bile duct stone is 8 to 10 mm in diameter'x and in most cases can be easily pulled into the duodenum using a balloon catheter or Dormia basket.17 ES with clearance of the biliary tree of stones is successful in 85 to 90% of when performed by experienced endoscopists. Failure to achieve ES or duct clearance may occur for a variety of reasons. Inability to cannulate the bile


rubin being elevated in 70 to 80%. The serum transaminases returned to normal levels within 10 days in the majority of patients, despite the persistent presence of common duct stones. Direct-reacting bilirubin is most commonly in the 2 to 10 mgldl range, with higher values indicating associated liver disease or nearly complete obstruction. "' The serum transaminase levels are modestly elevated in the majority but can reach over 1000 IUIliter immediately after a high-grade obstruction." The elevation in AP may be transient (if the obstruction resolves) and its height does not correlate with the degree of obstruction or the level of bilirubin."' The white blood cell count may be elevated with cholangitis or be depressed with overwhelming sepsis." Over 90% of patients with biliary pancreatitis have elevated serum amylase levels and these values are, overall, higher than those observed in patients with alcoholic pancreatitis."


TABLE 4.

Indications for ERCP-Sphincterotomy in Choledocholithiasis

I . Postcholecystectonly ( n o T-tube In) 2. Postcholecy\tectonly (T-tube in) Syn~ptomaticpatient with immature T-t11betract Failed T-tube extraction 3. Gallbladder in situ Elderly patient High operative risk patient !' patients choosing nonoperative gallbl;idder stone managenlent alternative 4 . Gall\tone pancreatit~s

duct deeply may occur, but precutting techniques have access to the largely bypassed this problem. Endos~x~pic papilla of Vater and subsequent cannulation and sphincterotomv can be difficult in ~ a t i e n t swith Billroth 11 resections. Successful cannulation has been achieved in 46 to 88% of such patientsi' and appears to be influenced In one series, ERCP was by the type of ana~tomosis.'~ successfully performed on 64% of patients with a retrocolic gastroenterostorny and a short afferent limb but in only 33% of patients with an antecolic gastroenterostomy with a long afferent limb.'' More recently, sphinctero;omy was c(impleted in 92% of patients with Billroth I1 anastomosis using a "30-30" papillotome or by Successful cancreating a suprapapillary fi~tulotomy.'~ nulation in patients with a Roux-en-Y gastrojejunostomy is rare. A transhepatically placed guide wire (combined procedure) may help to bring the-endoscope to the papilla and therefore improve the chance of successful cannulation and sphincterotomy." Periampullary diverticula are frequently associated with stone disease. especially in elderly patients,5hand can be a cause for a failed cannulation when the papillary orifice is within the diverticulum itself. If the papilla cannot be coaxed into view, a transhepatically placed guide wire through the papillary orifice will aid in successful cannulation and sphincterotomy. More often. failure to perform IIS or clear the duct is due to a large stone, impacted stone. or stone proximal to a ductal or ampullary stricture. Until recently, the large stone (usually defined as greater than 15 mm in diameter) was often managed surgica.lly. Attempts to remove a large stone with a standard basket may result in basket impaction. Currently, a nurrtber of nonsurgical options exist for such "difficult" stones (discussed later).

a

TABLE 5.

10, NUMBER 3, 1990

ES generally has a 6 to 10% major complication rate and a 0.4 to 1.2% mortalitv rate."-5' However, selected series of high-risk elderly patients had major complication rates as high as 19% and mortality rates of 7.9%.h" These complications are bleeding, perforation, infection, pancreatitis, and basket impactions. Approximately 20% of these events will require surgical intervention. Because of its significant risk and the unknown permanent effects of sphincter ablation, some authorities have suggested that "small stones" be removed after papillary balloon dilation, or the use of smooth muscle relaxants (example, nitr~glycerin)."~."' Table 5 summarizes the success and complication rates of ES performed for bile duct ~ t o n e s . ~

Mechanical Lithotripsy The simplest endoscopic adjunct for large stone management is a mechanical lithotripter or "crushing basket." In this technique, stones are captured in standard fashion by a wire basket made of three or more strong stainless steel wires that can stand a traction of greater than 100 kg. By turning a screw, the wires enclose the stone until it is crushed or the wires break." Because of the stiffness of the steel coil sheath, the early models of mechanical lithotripters were difficult to insert into the common bile duct. The more recent models are provided with double sheaths made of a steel coil and a Teflon tube."-' The basket with the Teflon sheath alone is relatively easy to insert into the common bile duct. The steel sheath (outer sheath) is then advanced over the inner sheath to crush the stone grasped in the basket forceps. Mechanical lithotripsy has proved efficient in the majority of clinical investigations with fragmentation rates between 27 and loo%, including "giant stones" with maximal diameters up to 80 mm.h5-hxIn the largest series reported, 209 patients required mechanical lithotripsy owing to stone size alone (80.4%). or in combination with common bile duct features such as an Sshaped configuration (12.4%) or a stenosis below the calculi (7.2%)."' The overall success rate for this series was 87.6%, including 79.1% for common bile duct stones 20 mm or larger and 67.6% for stones 25 mm or larger. The introduction of stronger wire baskets with a breaking strength of approximately 125 kg increased the success^ rate of mechanical lithotripsy, especially for large and "giant" common bile duct stones to 92.3% (20 mm or larger) and 85.7% (25 mm or larger), respec-

Success and Conlplication Rates of Endoscopic Sphincterotomy Performed for Calculi* Arter~rl~tc~tl

A~rrl~or-

Classen and Salrany 1975 Safrany 1978 Cotton and Vallon 198 I Siegel 1981 Cotton and Vallon I982 Neoptolcmos r~ (11. I984 Hatfield 1985 Total

.S/)hirrc~te~1-~1to1rr1c~.s

59 3853 679 235 71 100 -256 5253

S~~c.c~c,s.\/irl Sl~lrirre~tc~roto~rric~s

50 36 1 8 590 230 70 98 24 1 4897 ( 9 3 % )

"Adapted from Johnson and Hosking.' Reprinted by permi\\ion

O~.c,rtrllPrrc.rrrtergc, i ~ / ' f l ~ r c ~Cletrr-etl t.s

84% 90% 76% 97% 87% 9 1 %' 85% 88%

Morhitlir!

2% 7% 8.5% 5%' 6% 13% 9.5% 7%

Morttrlit\

OR 1.4% IQ 0.8%' 0R I %'

0 0 IR


208

MANAGEMENT OF BILE DUCT STONES-SHERMAN.

HAWES, LEHMAN

Laser Lithotripsy Laser fragmentation of ureteral stones is an established technique. Similar applications for bile duct stones and gallbladder stones have been reported. Stones may be fragmented by: ( 1 ) frank heating and melting, ( 2 ) focal heating and induction of fracture lines, or ( 3 ) photoacoustic, essentially athermal methods."' In the initial report by Orii et a17' the continuous wave neodymium: yttrium-aluminum-garnet (Nd:YAG) laser was used. Although largely successful. the associated tissue heating was thought to be prohibitive for general use of this method. More recent reports using short duration (nanosecond or microsecond) pulsed laser techniques have shown its ability to fragment stones in vitro with essentially no heat transfer to the stone o r surrounding 1nedia.7U 72.71 Although fragmentation may occur with variable light wavelengths, wavelengths of approximately 500 nm appear to give optimal fragmentation with low energy requirements. Stones of any composition can be fragmented by laser energy but pigment stones require considerably less energy than cholesterol stones. Calcium content appears to have little affect on fragmentation. Fragmentation occurs much more readily if the laser fiber and the stone are in an aqueous medium, rather than air. Bile absorbs laser light and is therefore detrimental to fragmentation, but helps to protect adjacent rnucosa. Although numerous lasers have been tested, the pulsed dye coumarin green laser (Candela Corporation, Natick, M A ) is the only Food and Drug Ad~ninistration (FDA) approved laser for biliary stones."." In Europe, Q-switched Nd:YAG lasers (nanosecond pulse duration) are also commercially available. Unfortunately, the standard commercially available continuous wave Nd:YAG laser used for gastrointestinal tumor ablation and bleeding cannot easily be modified fix delivery of short duration pulses. For bile duct work, laser energy is usually delivered by 200 to 350 k m diameter quartz fibers that pass through standard endoscopic channels. Via the duoden-

FIG. 1. Daughter endoscope passed up bile duct via the mother endoscope to visualize common duct stones. A laser fiber is passed through daughter endoscope for performance of laser lithotripsy.

oscope, the laser fiber can be passed through a modified stone retrieval balloon, modified Dormia basket, or the mother-daughter endoscope system (see Fig. I ). Balloons offer the simplest application but provide the least certainty for laser fiber to stone approximation. Baskets require capturing the stone but permit direct placement of the fiber against the stone via the accessory lumen within the basket sheath. The mother-daughter system permits direct viewing and the most accurate fiber placement but does require prior placement of a nasobiliary tube for saline irrigation to wash away stone fragments which quickly obscure the viewing area. Such saline wash permits an optimal aqueous medium for transfer of laser energy to the stone. These same techniques may be applied through T-tube tracts or by percutaneous transhepatic routes. reported a series of nine patients with Ell et common duct stones treated with the flash lamp pulsed Nd:YAG laser. Eight of nine large (larger than 25 mm diameter) stones were fragmented and in six of the nine patients the duct was fully cleared of calculi. Failed patients were treated by surgery, internal drainage o r extracorporeal shock-wave lithotripsy (ESWL). In a preliminary report, Cotton et a17j treated 14 patients with the pulsed dye laser. Treatments were applied by percutaneous tracts (n = 3), mother-daughter system ( n = 8), and


tively. Failure to clear the stones occurred in 12.4% and was due either to the inability to pass ( I 1.1 %) or to capture the stone with the basket (88.9%) because of its size, common bile duct configuration, disproportion between stone size and common bile duct diameter, inadequate "unfolding" of the basket, or other technical problems. Complications of mechanical extraction were primarily related to ES. The mechanical lithotripter has also been used successfully to fragment and remove stones through an intact papilla,"" although this application has been limited. Mechanical lithotripsy is a safe. relatively effective. and inexpensive technique. Where available. it is the method of choice to remove most large stones (15 mm or larger). However. because stones must be captured in a basket to be fragmented, at least some of them will escape destruction (usually stone size greater than 25 nim).

ERCP balloon technique (n = 3). Ninr: of 14 patients had complete stone clearance. At the Indiana University Medical Center, we have treated eight patients with large bile duct calculi. Four were treated by percutaneous transhepatic introduction of a small-caliber fiberscope (Olympus BF type 3C10) and four were treated by ERCP balloon or mother-daughter technique. Successful fragmentation and duct clearance occurred in six of the eight cases. The failed cases were treated with internal stents. To date, complications have not been reported in any of the series. However, therapy sessions commonly require 1 to 3 hours (especially with the mother-daughter technique) and are tedious for elderly patients. Kozarek et a17' and Murray et a173both reported that small foci of mucosal desiccation occur if the laser is fired directly against the mucosa for several secontls. The pulsed dye laser produces an easily audible (with stethoscope) knocking sound and an endoscopically visible flash when the laser fiber is fired against the stone. This helps the operator to judge appropriate stone contact. The comparative advantages of Iilser lithotripsy are: (1) the relative availability of the pulsed dye laser (approximately 200 currently in hospitals in the United States); (2) the relative safety, that is, lack of bile duct injury; (3) the multiple routes and methods of application; and (4) the relatively good success rate (approximately 70%) despite its use primarily with very large stones. The relative disadvantages are: ( I ) the time and manpower requirements to operate the mother-daughter system; (2) the fragility of the baby scope; (3) the relatively large costs of the lasers; and (4) the need for (generally) a large sphincterotomy and extraction of fragments. Overall, laser lithotripsy is still in its infancy. Larger experience with various laser fibers and power settings from multiple centers are needed. To make laser lithotripsy cost effective, the laser must be used for other areas, that is, kidney stones and gallbladder stones. Our initial experience with the pulsed dye laser for fragmentation of gallbladder stones by percutaneous approach fragmenhas been generally favorable, with s~~ccessful tation and gallbladder clearance in seven of nine patients.

Electrohydraulic Lithotripsy Electrohydraulic lithotripsy depends on the principle that electrical sparks discharged in a liquid medium emit steep hydraulic pressure waves. These acoustic shocks are so energetic that concrernents can be fragmented but will leave elastic structures for the most part uninjured.'" Intrabiliary lithotripsy can be performed using balloon-tipped probes that fit through the channel of the therapeutic duodenoscope. Once in the duct, the balloon must be inflated to keep the probe centered during firing. This avoids injury to the bile duct wall.7bUsing fluoroscopic guidance, multiple short bursts are administered, resulting in stone fragmentation. In animal studies using implanted human stones, fragmentation was successful and duct in-jury did not o c c ~ r . ~In~ .two ~ ' se-

10. NUMBER 3, 1990

ries totaling 26 patients, successful fragmentation occurred in 22 of 26 (85%) patient^.^".^" The only complication was pancreatitis in one patient, which resolved with conservative treatment. Other authorities prefer to use the small diameter electrohydraulic lithotripsy probe under direct vision via per oral cholangioscopy ("baby scope") to monitor more closely the direct contact between the spark discharge chamber and the stone." This technique was used successfully to fragment large (larger than 20 mm) common bile duct stones in four patients without complication^.^' Electrohydraulic lithotripsy has distinct advantages when done under direct vision using the baby scope, namely: ( 1 ) bile duct damage can probably be avoided, (2) it is more economical than laser lithotripsy; and (3) the unit is easily transportable. Although the experience with this technique is still limited, electrohydraulic lithotripsy appears to be a viable alternative therapy when performed by experts using direct cholangioscopy.

Stents and Nasobiliary Drains Long-term internal stenting is a good palliative measure in old and high-risk patients with nonextractable bile duct stones. In this technique, a stent is placed so that one limb is above the stone and another in the duodenum. Although stents often clog within months, longterm drainage is maintained because the stent prevents stone impaction. Patency of the prosthesis is therefore not important and stent changes are generally not required unless the stent spontaneously migrates out of the duct. The latter may occur when a large sphincterotomy has been performed in an attempt to remove the stone. Most authors recommend double pigtail stents, although Cotton had favorable experience with straight 10 F stents placed well up into the intrahepatic duct^.^' If 7 F double pigtail stents are used, placement of two stents will probably assure stent persistence better than one. '~ et aIx4and Cotton et alx' Siegel and Y a t t ~ , Foutch reported series of 22, 10, and 17 patients, respectively, with large common duct stones in which ERCP-sphincterotomy had failed to remove the stones. Median follow-up in these series was 18 to 39 months, with the longest follow-up being 5 years. Although the size, number, and type of stents varied within the series, only 5 of the 49 patients developed bile duct stone complications, that is, stent dislodgement and/or cholangitis. These patients were managed surgically or by restenting. A few patients had their stones extracted on a subsequent endoscopic attempt. These intermediate duration results from stenting are encouraging and indicate that such therapy is clearly appropriate for elderly and high-risk patients. Long-term follow-up and additional studies will be needed to answer questions concerning: (1) optimal size, number, and shape of stents; (2) true long-term complication rates; and (3) the role of combined use of stents and oral bile salt dissolution therapy. Preliminary data from Chung et alx' indicate that six of seven patients with large bile duct stones treated with stenting plus chenodeoxycholic acid had stone dissolu-



210

HAWES, LEHMAN

21 1

plete clearance of all stones during initial follow-up, tion or reduction in size to a degree to permit extraction. although approximately 75% of patients required addiThis contrasted with only one of six patients treated with tional ERCP or percutaneous extraction of fragments. a stent alone. In contrast, Cotton et alx' stated that none Such success rates are remarkably high considering the of nine patients treated with ursodeoxycholic acid plus large diameters (commonly more than 20 mm) of stones stenting appeared to have benefited from the bile salt being treated. therapy, although the dose and duration of therapy were Complications occurred in approximately one third not reported. Overall, we believe the addition of bile salt of patients, but consisted mainly of transient hemobilia therapy to the use of stents appears attractive, although or hematuria and apparently clinically insignificant arthe cost efficacy of such a recommendation clearly needs rhythmias or minimal fever. Serious complications were further study. reported in 13 of 374 (3.5%) patients. These complicaA nasobiliary tube can be placed as a temporizing measure if stones cannot be extracted e n d ~ s c o p i c a l l y . ~ ~tions appeared to be predominantly those of native gallstone disease, that is, biliary colic with or without choThis tube will prevent stone impaction and allow drainlecystitis. Prophylactic antibiotics were not uniformly age while more definitive therapy is contemplated. given in these series. Other significant complications apMoreover, the drain permits infusion of chemical dissopeared to be predominantly those of ERCP-ES and conlution agents (which appear to have limited efficacy with sisted of basket impaction in two patients and duodenal large stones), allows for repeat cholangiographic assessdiverticulum perforations in two patients. Significant ment of the common bile duct, and enables accurate fopancreatitis was notably absent. Two deaths resulted cusing for such treatments as ESWL. from major complications. The relative advantages of ESWL therapy include: Extracorporeal Shockwave Lithotripsy (1) the availability of many first-generation machines in medical communities; (2) the minimal invasiveness of ESWL has been utilized for ductal stones in a fashthe procedure; (3) the reported high success rate of stone ion similar to renal or gallbladder applications. Several clearance even when applied to large stones; and (4) the hundred patients have now been reported in the medical relatively low complication rate. The relative disadvanliterature. Most centers have used the first-generation retages include: (1) the lack of FDA approval for use of nal machines using fluoroscopic visualization by nasomachines in the biliary tree; (2) high cost of such mabiliary or percutaneous (transhepatic, cholecystic, or Tchines; (3) the need for a percutaneous or nasobiliary tube) contrast instillation. Access is generally from the tube for cholangiography, (4) the need for general, epiposterior in order to avoid a gas-filled bowel. Epidural, dural, or intravenous anesthesia; and (5) the need for exgeneral, or heavy intravenous anesthesia is usually retraction of fragments (ERCP or percutaneous) in most quired. Reports with more focused piezoelectric (essentially painless) machines are now a p p e a r i ~ ~ g . Anti~ ' . ~ ~ patients. In summary, the application of ESWL for bile duct biotic coverage appears necessary, as with any common stones is evolving. Where available, it appears as a good bile duct stone manipulation. "next approach" for patients in whom ERCP maneuvers The usage of ESWL therapy has generally been rehave failed to clear the ducts of stones. Additionally, this stricted to patients in whom endoscopic sphincterotomy therapy appears attractive to fragment stones, which then with or without mechanical lithotripsy or infusion of dismay permit easier application of dissolving agents and1 solving agents has failed to clear the ducts of the stones. or smaller sphincterotomies (with potentially lower comAdditionally, patients with restricted access to the major plication rates). FDA approval and additional experience papilla via endoscopy (duodenal diverticula or gastrojewith second-generation machines, which require that junostomy) have been treated. A multicenter European less analgesia be administered to patients, are awaited. trialx"ound that 8.3% of patients referred for endoscopic Further information about this technique will be found therapy ultimately were referred on for ESWL therapy. in the review by Albert and Fromm elsewhere in this Contraindications to such therapy are the presence of exissue of Seminars. cessive air or bony structures, calcified vessels, renal cysts, or vascular aneurysms in the path of the shock wave, coagulopathy, significant cardiac arrhythmia, or DISSOLUTION cardiac pacemaker. Twelve hundred to 2400 shocks in one to two sessions have generally been given. In the Contact Dissolution United States, none of the machines has yet been approved by the FDA for biliary use. Bile duct stones are insoluble precipitates of In 12 report^^'-^^ summarized from the literature a aqueous bile. Dissolving such stones via ductal irrigation total 374 patients with bile duct stones (includes comremains an attractive alternative. Unfortunately, search mon bile duct, common hepatic duct, and intrahepatic for a rapidly effective, inexpensive, readily available duct stones) were treated by ESWL. Nearly all patients solvent remains elusive. Solvents may be instilled by had prior endoscopic sphincterotomy and a failed atpercutaneous transhepatic or cholecystic, T-tube, or natempt at stone removal. Although not all series separated sobiliary routes. Complete dissolution is not required besuccessful fragmentation from eventual duct clearance, cause smaller fragments may be flushed out or extracted. 194 of 232 (84%) reported patients had successful fragmentation, whereas 296 of 374 (79%) patients had comMonoctanoin (Moctanin) is the only readily available,


MANAGEMENT OF BILE DUCT STONES-SHERMAN,


212

FDA approved, agent for bile duct stone dissolution. This agent is a reasonably effective cholesterol solvent but requires prolonged stone and solvent contact time." In a review of the published experience of 343 patients treated with monoctanoin, partial or complete stone dissolution occurred in 5~4%."~'Dissolution therapy appeared to be more successful with smaller stones. Average therapy duration was 7 days. Unfortunately, 67% of patients experienced side effects, although most of these were mild.'"' Such marginal efficacy of monoctanoin largely limits its practical utilization to the early postoperative setting via T-tube route (see Algorithm, Fig 2). Unfortunately, large stones that fail ERCP-ES removal are usually refractory to monoctanoin infusion.

10, NUMBER 3, 1990

Methyl tert-butyl ether (MTBE) is a powerful cholesterol solvent."" The speed and efficacy of MTBE for cholesterol gallstone dissolution is well documented."" Its efficacy and toxicity for common bile duct stones are more problematic. In summarizing 64 patients reported in five published 18 patients had complete stone dissolution and an additional 18 had partial dissolution, which then aided subsequent stone removal. Overall, 56% of patients appeared to have benefited from MTBE. As with monoctanoin, small stones dissolve more readily than large stones. The frequency of complications varied in these series but, overall, approximately half the patients had drowsiness, nausea, or abdominal pain. Duodenitis may be observed on endos-

/

Stone 18mm diameter

Saline flush sphincter relaxants

+

fail

Significant NolYes symptomslcholangitis

Walt 5-6 weeks

LAsympt~matic

or minor symptoms

Very high risk patient (e.g. long term anticoagulation)

Dissoivent infusions: monoctanoin; methyl tertiary butyl ether (if available)

t-

7

Oral agent dissolution

--

and stone Endoscopic Y/e) extractlon Sphincterotomy Failed Ext raction

Failed Sphincterotomy

Very high risk patient

J

Endoscopic Access Stent

+ oral percutaneous transhepatic procedure

Good risk patient YeslNo

agent dissolution Approach varies with locallregional facilities and expertise

Percutaneous Transhepat ic extractionlfragmentation dissolution Surgical Bile Duct Exploration

Mechanical Laser or Electrohydraulic DissoiutionlNasobiiiary tube

+

Lithotripsy

\

Above fails or not available

FIG. 2. Management of patients with postcholecystectomy bile duct stones as well as the elderly and high-risk patients with gallbladder in situ.


T-Tube in-situ

HAWES, LEHMAN

copy. Close contact between MTBE and the bile duct stone is necessary for dissolution. Because of its low specific gravity, MTBE will float on bile and may separate from stones. Therefore the biliary tube must be appropriately positioned for maximal contact. Aspiration of bile before MTBE administration also facilitates contact. In addition, the use of a balloon to block MTBE flow into the duodenum will not only facilitate dissolution, but may help to prevent side effects.ln5Ether-resistant balloons must be used. Based on the information just given and the current lack of FDA approval for this agent, it is unlikely that MTBE will be widely used for ductal stones, although it may have a role in the postoperative state with a T-tube in place. Most primary duct stones contain little or no lipidsoluble material and therefore will not dissolve in lipid solvents. Ethylene diaminetetraacetic acid (EDTA) solutions with varying combinations of detergents are being evaluated for dissolution of primary (calcium bilirubinate) stones."" Leung and colleague^"'^ used 1% EDTA bile duct irrigations in patients with large pigment stones and recurrent cholangitis. It is unclear from their data whether the success rate (50%) was due to simple mechanical flushing and enhanced breaking up of stones or was actually due to dissolution.""

Oral Agent Dissolution Oral agents have been used in an attempt to dissolve common duct stones. The results with chenodeoxycholic acid have shown limited success, since only 10 to 44% of stones completely disappeared. "0-"4 In a randomized double-blind placebo-control study evaluating the efficacy of ursodeoxycholic acid, 28 patients with common duct stones, but no evidence of cholangitis or jaundice (plasma bilirubin less than 2 mgidl), were entered.lI5 Fourteen patients were treated with ursodeoxycholic acid at a dose of 12 mglkglday for up to 2 years. In the treated group, the stones completely dissolved in seven and partially in one (57.1%) while the stone size and number remained unchanged in patients taking the placebo (p = 0.0003). Abdominal pain and biliary colic became less frequent in the treatment group (p < 0.05) compared with the placebo group. Moreover, three patients in the placebo group developed complications requiring surgery in contrast to only one in the treated group. Lirussi et al"' reported the disappearance of intrahepatic stones

TABLE 6. Series (Ref No.)

2 13

in three patients after 2 to 3 months of ursodeoxycholic acid at 1.2 gmlday. In another study assessing the efficacy of oral dissolution therapy, patients with radiolucent common duct stones were treated with Rowachol (a terpene preparation) alone, or in combination with chenodeoxycholic acid or ursodeoxycholic acid."' Forty-two percent of patients treated with Rowachol achieved complete stone disappearance within 3 to 48 months. When Rowachol was combined with chenodeoxycholic acid or ursodeoxycholic acid, 72% of patients achieved complete dissolution within 18 months. In summary, oral bile salt therapy appears attractive for the small subpopulation of bile duct stone patients who are only minimally symptomatic, not jaundiced, and are at high risk for any intervention (such as hemophiliacs). Oral agents appear to be appropriate supplements to ESWL or other fragmentation methods.

SPECIAL PROBLEMS Common Bile Duct Stones with Gallbladder in Situ Even in the absence of controlled trials comparing surgery to ES for common bile duct stones, the widespread favorable experience with ES has led to its present ~ositionas the treatment of choice in most centers for patients with choledocholithiasis who have had a cholecy~tectomy."~ More recently, ES has now been suggested as a viable alternative for patients with symptomatic common duct stones with gallbladder in situ who have an anticipated high operative risk. The incidence of complications after surgical choledochotomy in patients over 65 years old has been reported to be as high as 30%,"9,"0 with mortality rates varying between 2.9 and 4.4%"' and as high as 5 to 28%."'."3 These figures are considerably higher than those generally reported with ES, as already noted (6 to 10% and 0 . 4 to 1.2%, respectively). The fear of doing an ES without removal of the gallbladder is the subsequent development of gallbladder and biliary complications ultimately requiring surgery.'24 Although long-term follow-up is not available in many series, objections to this approach do not seem to be supported by current data (Table 6)45.'"'"' The incidence of subsequent cholecystitis and biliary tract complications are low. Those patients requiring urgent cholecystectomy usually do so within the first year after ES. The risk of

Need for Cholecystectomy After Endoscopic Sphincterotomy with Gallbladder in Situ* No. Putients

Av. Age (vrJ

*Adapted from Dowsett et al." Reprinted by permission tMedian.

Follow-up mos. (MeaniRanpeJ

No. Operations Needed

Other Biliary Svmntoms

Lute Deaths



214


10, NUMBER 3, 1990

TABLE 7. Results of a Prospective Randomized Trial of Conventional Treatment Versus ERCP Suspected Acute Gallstone Pancreatitis* Corri/~lic~titioi~s

+ ES in N o . Patients with

Mild-conventional GS. confirmed GS, not confirmed Mild-ERCPIES GS. confirmed GS. not confirmed Severe-conventional GS, confirmed GS, not confirmed Severe-ERCPIES GS. confirmed GS. not confirmed

developing gallbladder symptoms requiring surgery appears greater for those with a blocked cystic duct at the time of ERCP and those with ~ h o l e l i t h i a s i s . ' ~ ' - ~ " The role of ES in patients with an intact gallbladder who are a good surgical risk is more controversial. Because the mortality rate of common bile duct exploration in patients less than 60 years old is 1 to 2% (similar to ES),"'."" most young patients should probably undergo surgery. However, with deve1opmr:nt of nonsurgical techniques for treating gallbladder stones (example, ESWL, chemical dissolution, laser lithotripsy), it may be realistic for a patient to be treated solely by a nonsurgical regimen.

done whether or not common bile duct stones were present; (2) there was a significant reduction in the major complications of patients who underwent urgent ERCP and ES (p = 0.03); (3) the reduction in morbidity was only apparent in those with predicted severe attacks (p = 0.007); (4) there was a significant reduction in hospital stay for those with severe attacks treated with urgent ERCP and ES (median 9.5 days versus 17 days, p = 0.03).i4"Mortality, however, was not found to be statistically different. This evidence leaves little doubt that ES has an important role in the management of severe gallstone pancreatitis. This therapy should also be considered in patients with a mild attack who fail to improve.

Acute Gallstone Pancreatitis Most patients with gallstone pancreatitis have a mild attack and can be treated conservatively. 1 3 ' . 1 ' J The mortality rate from this disease overall is about 15%.13' Early surgical treatment has been reported as benefi~ i a l , ' ~detrimental,137.'3%r ' of no harm. '3".'J0 Many of these studies suffer from their use of retrospective data, historical controls, and lack of definition of the severity of pancreatitis. Because many studies have found that urgent surgery (particularly for severe disease) is associated with increased mortality, this approach has not gained general acceptance. Since its introduction in 1978 for patients with acute gallstone pancreatitis, ERCP and ES have proved to be safe and probably effective. 1'"-14J Although these uncontrolled reports were encouraging, studies varied in their methods of patient selection and timing of ES in relation to the acute attack (many were done in the postacute phase when surgery is also safe). More recently, in a randomized prospective controlled trial for acute biliary pancreatitis, 121 patients were entered to receive either conventional therapy or to undergo urgent (within 72 hours) ERCP with ES and stone extraction (if stones were present in the common bile duct at the time of the ERCP)."" Patients were stratified by the predicted severity of their attack using the modified Glasgow system. The results are seen in Table 7. The four important findings are: (1) ERCP could be safely

Role of Endoscopic Clearance of the Bile Duct Prior to Cholecystectomy In the surgically low-risk group of patients with symptomatic common duct stones and gallbladder in situ, it has been suggested that a preoperative ERCP and ES be done.'47The hypothesis is that the combined risks of ES and cholecystectomy are less than cholecystectomy and common bile duct exploration.148In a randomized study testing this hypothesis, the overall complication rate (major plus minor) for the group treated by ES and cholecystectomy was 32.7%, compared to 22% in the group treated by surgery alone (not statistically different).'" Mortality was not different in the two groups, but hospitalization was shorter for the combined procedure group. The study was terminated after the trend against preoperative endoscopic sphincterotomy emerged. Of interest, most of the complications in the ES group were in those who failed ES or stone extraction. As Cotton'4x points out, the use of a nasobiliary tube or temporary stenting (not performed in this study for patients who failed ES or stone extraction) probably would have lowered the complication rate in these patients. In a nonrandomized study, the effects of endoscopic removal of common duct stones before elective cholecystectomy was compared with cholecystectomy and common bile duct exploration for patients with


'"Adapted from Neoptolemos and Carr-Locke."" Repr~ntedby pcrmissil tGS: gall\tonea.

HAWES, LEHMAN

symptomatic choledocholithiasis, but without "prohibitive surgical risk."I5" In patients who underwent operative common duct stone removal, the complication rate was 21.8%. This rate was reduced to 2.1% by preoperative ERCP and stone extraction. The retained stone rate (2.2 to 0.5%) and mortality rate (3.8 to 1%) was similarly reduced by preoperative endoscopic stone removal. The authors concluded that endoscopic removal of common bile duct stones before elective cholecystectomy is a suitable approach to reducing the morbidity of biliary tract surgery. The opposing results of these two studies in part reflect different patient populations, different study protocols, and perhaps varying expertise of the surgeons and endoscopists. Additional prospective comparative studies are needed to clarify this issue.

PERCUTANEOUS METHODS TO TREAT CHOLEDOCHOLITHIASIS

2 15

believed to be high surgical risks), but are clearly higher than that associated with ES and stone removal. It is noteworthy that 32 patients referred for this procedure had failed ES, refused ES, or had unfavorable anatomy to perform a sphincterotomy (that is, patients had a choledochojejunostomy). Transhepatic balloon dilation of the distal common bile duct and ampulla of Vater is a relatively new technique. Using this method, Berkman and colleague^'^^ successfully pushed common bile duct calculi into the duodenum in 17 patients without any significant complications or mortality. Eight of the 17 patients in this series had failed to have their stones removed endoscopically. A percutaneous transhepatic route for the introduction of a fiberoptic choledochoscope is an alternative method to remove biliary stones. In a series from Taiwan, stones were successfully removed in 80% with only one patient of 20 having a significant complication. Stone removal is facilitated by initial fragmentation via electrohydraulic or laser lithotripsy under direct vision through the c h o l e d o ~ h o s c o p e . ~ ~ ~ Combined percutaneous and endoscopic procedures have been used successfully to treat choledocholithiasis when endoscopic access to the biliary tree cannot be accomplished. 1h'.17"

Mechanical extraction techniques using fluoroscopic guidance are routinely used to remove stones in 7 commonest application of the common duct. 1 s 1 - 1 5The these techniques is in the patient with retained common duct stones after cholecystectomy when a T-tube remains in place. Retained stones may occur in up to 15% of '~".~~~ patients after common bile duct e ~ p l o r a t i o n . " ~ Some of these stones may pass, but in the majority. they will SURGICAL TREATMENT OF COMMON have to be removed."" Further surgical exploration has BILE DUCT STONES higher morbidity and mortality and is less successful than the first Surgical therapy represented the only successful With adequate experience, the success rate of stone extraction via a T-tube should treatment of common duct disease until 15 years ago. approach 95%, with complications occurring in less than Choledochotomy and choledocholithotomy were the 5%.1".157Retained small common duct stones may also principal surgical therapies for common duct stones. If be removed with a variable success rate of 25 to 50% by surgery is performed primarily for cholelithiasis and saline flush with passage aided by coincident use of glucommon bile duct stones are suspected, an intraoperative cagon, nitroglycerin, or ceruletide to relax the sphinccholangiogram should be performed via the cystic duct. I' ter, 1 5 x . l This ~ ~ technique has the advantage of not requirIntraoperative cholangiography has been shown to deing 4 to 6 weeks for T-tube tract maturation. The use of crease the incidence of negative common duct exploramonoctanoin has met with variable success, as already tions (65 to 35%) and missed common duct stones (15 d e ~ c r i b e d . ' ~The " experienced radiologist can employ to 8%).".171 Absolute indications for exploring the common duct include a positive intraoperative cholangiolithotripsy (mechanical, electrohydraulic, or laser) with gram, known choledocholithiasis, palpable common or without the aid of choledochoscopy if routine extracduct stones, and active cholangitis.' During common tion methods fail. duct exploration, a drainage procedure (that is, sphincUsing mechanical extraction techniques when a Ttube tract is not available requires that a percutaneous teroplasty or choledochoduodenostomy) is generally intranshepatic entry to the bile duct be made with a condicated for any of the following: previous common bile comitant increase in invasiveness and complication duct exploration, distal stricture, multiple stones, or inrate. I " I . I"' In general, mechanical extraction of bile duct ability to remove all Recent evidence demonstones via a transhepatic approach should be reserved for strating a high incidence of bacteria within pigment those patients in whom ES failed and who are considered stones would suggest that a drainage procedure be performed if pigment stones are found."ntraoperative chopoor surgical c a n d i d a t e ~ . l " ~In. l ~a ~series of 50 patients with symptomatic common duct stones, percutaneous ledochoscopy has been shown to decrease the incidence transhepatic removal was successful in 93%. ''"tones or of overlooked stones from 8-10% to 24%.".17' A fragments in the common duct were pushed (using a T-tube should be left in the common duct for cholangiDormia basket) into the duodenum through a balloonography prior to terminating the operation as well as afdilated papilla or previously created sphincterotomy. ter the procedure to check for residual stones and to faMonooctanoin (25 patients) or MTBE (four patients) was cilitate biliary decompression. After 5 to 7 days of used to reduce stone size or remove residual debris. gravity drainage, a cholangiogram should be done to Complications occurred in 17%, with a mortality of 4%. confirm the absence of stones or leak. The patient can then be discharged to return for T-tube removal 7 to 14 This complication and mortality rate compares favorably days later. to those of surgery (particularly since 22 patients were


MANAGEMENT O F BILE DUCT STONES-SHERMAN,


216

TABLE 8.

Morbidity and Mortality from Surgical Common Bile Duct Exploration* for Calculous Disease No. Ptrtic~~lt.s

Rqf: No.

10, NUMBER 3, 1990

Stutlx 1111c,rl~t1/

CCX (R)

Co111l1lic.c1rio11.s (%i

173 60

507 248

1978-1984 I981L19X5

100%

-

-

174 175

102 81

1976- 1986 1981-1986

7.5'1 94%

Major: 21 (8.5%) Minor: 35 (14%) Total 35 (34%) Major 5 (6%) Minor 8 ( 10%)

Total

938

Det1th.s (%l

9 ( 1 .X%) 10 ( 4 % ) I(I%) 1 (1.2%) 21 (2.2%)

*Includes biliary drainage procedure in selected patients tCCX: simultaneous cholecystectomy.

PATIENT MANAGEMENT ALGORITHM There is a remarkable variety c~ftechniques available to attack the bile duct stone. Figure 2 outlines a currently suggested sequential application of these techniques for patients with bile duct stones postcholecystectomy. Although patient management must be individualized, most patients with a T-tube in place can have their stones flushed out, dissolved, or extracted via the T-tube tract. Eighty-five to 90% of patients without a T-tube in place can have their bile duct stones successfully removed after ES using a balloon or Dormia basket. The majority of the remaining 10 to 15% of symptomatic patients may require more sophisticated endoscopic approaches using lithotripters or be managed by ESWL. Although such expertise is not always available in a given medical community, most patients can easily travel to a facility where these techniques are available. The patients failing to have their duct cleared of stones by endoscopic methods may be treated by laparotomy and common duct exploration if they are a good surgical risk. Very poor surgical risk patients who have failed endoscopic extraction can usually be tided over with stenting or percutaneous techniques.

SPHINCTER OF ODD1 DYSFUNCTION Commonly, the clinician will see patients with epigastric or right upper quadrant abdominal pain with back radiation, strongly suggestive of biliary colic, yet appropriate evaluation shows no evidence of gallbladder disease or bile duct stones. Gastroesophageal reflux, peptic ulcer disease, and pancreatitis should be considered. Additionally, such patients may have sphincter of Oddi dysfunction. This entity has been previously termed papillary stenosis, biliary dyskinesia, or postcholecystectomy syndrome. Surgical wedge specimens from the sphincter have identified adenomyosis, inflammation, muscular hypertrophy, or fibrosis in approximately 70% of pat i e n t ~ . " ~In . ' ~addition ~ to pain, these patients may have pancreatic or biliary ductal dilation as assessed by CT scan or ultrasound and may have elevation of pancreatic or hepatic enzymes. Hogan et have diagnosed and categorized sphincter of Oddi dysfunction based on ERCP, laboratory and clinical criteria (Table 9). Intraoperatively, surgeons have based the diagnosis on common bile duct flow and pressure studies or resistance to passage of a probe through the major papilla. More recently, ERCP biliary manometry has been shown to have the highest predictive value for sphincter of Oddi dysfunction. 17" Sphincter of Oddi manometry is generally performed using diazepam anesthesia with avoidance of narcotics and anticholinergics. A triple lumen 5 F catheter perfused by a low-compliance pneumohydraulic system is used. A basal sphincter of Oddi pressure of 40

TABLE 9.

Suspected Biliary Sphincter Dysfunction Classification*

Criteria A. Recurrent biliary-type pain 6 . Liver tests abnormalities? C . Dilated common bile duct ( > l I nim) D. Prolonged biliary drainage time (>45 minutes) Type I = A + B + C + D Type I1 = A + I or 2 o f B , C,or D Type 111 = A (pain only) *Adapted from Hogan et al"'. Reprinted by permission. tAlkaline phosphatase, bilirubin, or transaminase twice normal


As with surgery for any disease state, complications of the disease or the surgery may occur in the operative and postoperative intervals. The surgical complications result from the consequences of the surgery itself and more incidental events, such as myocardial infarction and stroke. These adverse outcomes are usually tallied through the first 30 days after surgery. In contrast, endoscopists and radiologists typically report only the directly related complications occurring in the immediate postprocedure interval. Unfortunately, reported complications are often not separated as to major or minor events. With these reservations, Table 8 summarizes the morbidity and mortality rates associated with common bile duct exploration for calculous disease. h".'73-'7' Of the 938 patients summarized, 6 to 8.5% had major complications and 2.2% died. Morbidity and mortality were increased if patients were older than 65 years, jaundiced, had acute cholangitis, or had significant systemic medical illness.

HAWES, LEHMAN

mmHg or higher appears to be the most reliable indicator of disease. We recommend use of sphincter of Oddi manometry in patients with clinically significant, but otherwise unexplained, pancreatobiliary pain or idiopathic pancreatitis to evaluate the sphincter for dysfunction more convincingly. In our own recent series of 128 patients with possible sphincter of Oddi dysfunction studied by manometry, 70%, 51%, and 29% of types I, 11, and 111 patients, respectively, had abnormal manometry. Once sphincter dysfunction has been documented. or surgical sphincteroendoscopic ~phincterotomy"')-~~' plasty~7fi.~77.~~' is generally recommended. Surgical sphincteroplasty h a s the advantage of convincingly severing the biliary and the pancreatic sphincters. ES leaves the pancreatic sphincter untouched but has the obvious advantage of not requiring a laparotomy. Sphincter ablation will give pain relief in approximately 75% of patients. Persistent symptoms, if present. may be due to residual or recurrent sphincter stenosis. chronic pancreatitis, or concomitant other diseases, especially irritable bowel syndrome. Treatment of patients with type 111 sphincter dysfunction is problematic. Such patients have only pain and abnormal sphincter manometry. Whether sphincter ablation is justified in this group or whether more vigorous medical management with nitrates, calin an atcium channel blockers, or antich~linergics'~' tempt to lower sphincter pressure are appropriate needs further study. ~ r o s ~ e c t i vstudies e currently are in progress at our institution comparing surgical sphincteroplasty, ES, and medical therapy for patients with sphincter of Oddi dysfunction.

CONCLUSION Over the past 15 years there has been a virtual explosion of technical advances that have aided the management of bile duct stones and their complications. Available treatment will depend on local facilities, experience, and expertise. Collaboration among the surgeon, interventional radiologist, and endoscopist offers the patient the maximal opportunity for the successful removal of bile duct stones with the least morbidity and mortality. The management of bile duct stones is still evolving. Changes and improvements in technology are likely to occur. More widespread availability and application of the new technologies is awaited. Safety and cost remain important considerations. Controlled trials will be needed to answer many remaining questions. The diagnostic and therapeutic advancements made in gallstone disease have highlighted this exciting era in medicine.

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2. 3.

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MANAGEMENT OF BILE DUCT STONES-SHERMAN.

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2 19

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Non-surgical management of bile duct stones.

Advances in the endoscopic management of common bile duct stones.

Single-session minimally invasive management of common bile duct stones.

Dealing with residual bile duct stones.

Bile duct stones and laparoscopic cholecystectomy.

Primary bile duct stones and bacterial activity.

Common bile duct stones: ERCP or surgery?

Surgical interventions for bile duct stones.

Dealing with residual bile duct stones.

Bile duct stones and laparoscopic cholecystectomy.

Bile duct stones and laparoscopic cholecystectomy.

Primary "brown pigment" bile duct stones.

Simple resection of the lesion bile duct branch for treatment of regional hepatic bile duct stones.

Common bile duct stones associated with pancreatobiliary reflux and disproportionate bile duct dilatation.

Reappraisal of endoscopic papillary balloon dilation for the management of common bile duct stones.

The role of sphincterotomy in the management of common bile duct stones.

Transduodenal endoscopic sphincterotomy and extraction of bile duct stones.

Non-surgical removal of common bile duct stones.

The value of extracorporeal shock-wave lithotripsy in the management of bile duct stones.

The Surgical Management of Concomitant Gallbladder and Common Bile Duct Stones.

Management of common bile duct stones with a biliary endoprosthesis. Report on 40 cases.

Diagnosis and management of common bile duct stones in patients with sickle hemoglobinopathies.

Prevention and treatment of recurrent bile duct stones by choledochoduodenostomy.

Identification of bile duct stones in patients undergoing laparoscopic cholecystectomy.