World J. Surg, 2, 457--464, 1978
Transduodenal Endoscopic Sphincterotomy and Extraction of Bile Duct Stones Laszlo Safrany, M.D. GastroenterologicalClinic,Reinhard-Nieter-Hospital,Wilhelmshaven,WestGermany
Retained and recurrent common bile duct stones have required surgical treatment. Recent advances in endoscopy, however, have made possible endoscopic management of choledocholithiasis. This report describes the method of endoscopic sphincterotomy and the results in 562 patients with choledocholithiasis in whom the procedure was attempted during the past 4 years. Endoscopic sphincterotomy was successfully accomplished in 523 patients (93%). There were 428 patients with retained or recurrent common bile duct stones after cholecystectomy. In 95 high-risk patients with choledocholithiasis and cholelithiasis, endoscopic sphincterotomy was carried out to relieve jaundice. In 188 patients the stones passed spontaneously after sphincterotomy. In 306 patients, the stones were extracted. Residual stones remained in 29 patients. Complications consisting of bleeding, retroperitoneai perforation, pancreatitis, cholangitis, and stone impaction occurred in 36 patients (6.9%). In 10 patients (1.9%), complications made emergency surgery necessary and resulted in 5 deaths for a mortality rate of 1%. The good results, low morbidity, and low mortality of endoscopic sphincterotomy support the suggestion that this method of treatment has earned a firm place in modern biliary surgery.
techniques for exploration of the ampulla of Vater and cannulation of the common bile duct established the basis for therapeutic procedures in this region [7-12]. Endoscopic sphincterotomy of the papilla of Vater is being increasingly applied in the therapy of biliary diseases. In the Federal Republic of Germany, endoscopic sphincterotomy has become an established and accepted form of treatment, and experience with over 2,000 such procedures has been recorded. Use of endoscopic sphincterotomy is now spreading throughout the world [11].
Material and M e t h o d s
Selection of Patients Between May, 1974 and March, 1978, there were 562 patients with choledocholithiasis considered for endoscopic sphincterotomy. The procedure was successfully performed in 523 patients, a success rate of 93%. There were 428 patients with retained or recurrent common bile duct stones after cholecystectomy. In 95 elderly, high-risk patients, endoscopic sphincterotomy was performed to relieve choledocholithiasis with jaundice; many of these patients had associated stones in the gallbladder. The male-to-female ratio was 158:365. The age of the patients ranged from 14 to 89 years, with a mean of 66 years (Table 1). The youngest patient, who was 14 years of age, had severe congenital heart disease that required implantation of an artificial heart valve. A bilirubin stone that was probably caused
In spite of intraoperative cholangiography [1, 2], choledochoscopy [1, 2], and methods for nonoperative extraction of retained common bile duct stones in the early postoperative period after cholecystectomy [3], choledocholithiasis is still a common disease requiring surgery [4, 5]. The morbidity and mortality of choledocholithotomy is not negligible [4], and both tend to rise with advancing age [4, 6]. The development of diagnostic endoscopic Reprint requests: Professor Dr. L. Safrany, ReinhardNieter-Krankenhaus, D-2940 Wilhelmshaven, West Germany.
9 457
0364-2313/78/0002-0457 $01.60 Soci6t6 lnternationale de Chirurgie
458
World J. Surg. Vol. 2, No. 4, July, 1978
Table 1. Age distribution of 523 patients who underwent successful endoscopic sphincterotomy. Age (years)*
Number of patients
11-20
1
21-30 31-40 41-50 51-60 61-70 71-80 81-90
4 14 36 70 188 171 39
*Mean age was 66 years.
by us [9]. This is a wire drawn through the catheter used for papillary cannulation (Fig. 1). The distal end of the wire is fixed to the tip of the catheter and when it is pulled, the tip of the catheter bends so that a segment of the wire separates from the catheter. The saw-like wire can be used as a cautery. The energy source was an Olympus PSD 3 diathermy unit. The mixed cutting and coagulating current was used for sphincterotomy, at an intensity of grade 3 on the scale. The Dormia basket catheter was used for extraction of stones, just as it has been used for extraction of calculi through a T-tube fistula tract [3].
Technique of Sphincterotomy
Fig. 1. High frequency diathermy sphincterotome. by hemolysis produced obstruction of the common bile duct and jaundice. The common duct stone was removed endoscopically.
The first step of the procedure is the selective retrograde cannulation of the biliary tract and injection of a radiopaque medium for x-rays (ERCP). After having observed the ampulla of Vater and clarified the anatomy of the biliary system, the sphincterotome is advanced into the bile duct and its position is established by fluoroscopy. The sphincterotome modified by us [9] has a metal tip which is easily discernible under the fluoroscope (Fig. 2). The sphincterotome is then drawn back under visual control, to the point where the proximal end of the free portion of the wire is just outside the papilla. The direction of the incision should be upwards at the 10 or 11 o'clock position when facing the papilla. The average length of the incision is 17 mm [131. Removal of common bile duct stones is undertaken with the Dormia basket catheter. Under fluoroscopic control, the closed catheter is advanced beyond the calculi, then the basket is opened, and an attempt is made to capture the stone and remove it from the bile duct. The captured stone can be pulled out of the duodenum together with the endoscope. Figure 3 shows the procedure diagrammatically.
Results
Removal of Stones Instruments Olympus JF-B2 and JF-B3 fiberduodenoscopes with an Olympus CLX light source were used for diagnostic cannulation of the ampulla of Vater and endoscopic retrograde cholangiopancreatography (ERCP). The sphincterotome consisted of a snare developed by Demling and Classen [7] and modified
In 36 patients, stones were spontaneously expelled into the duodenum immediately following sphincterotomy (Fig. 4). In 225 patients, the stones were extracted with the Dormia basket catheter immediately after sphincterotomy (Fig. 5). In patients with multiple stones and those in whom extraction of stones could not be accomplished easily, spontaneous passage of the stones was expected within a few
L. Safrany: Endoscopic Sphincterotomy for Choledocholithiasis
459
Fig. 2. False position of sphincterotome. In (A) the metal tip is in the main pancreatic duct. In (B) the sphincterotome is in the correct position in the common bile duct.
A.
B.
Table 2. Results of endoscopic sphincterotomy in 523 patients with choledocholithiasis. Spontaneous passage of stones Immediately after sphincterotomy Within 1 week after sphincterotomy Stone extraction Immediately after sphincterotomy 1 week after sphincterotomy Residual stones
C.
D.
Fig. 3. Diagram of steps in endoscopic sphincterotomy. A. Sphincterotome is inserted in closed position into the common bile duct. B. The proximal part of the bended wire appears just outside the papilla. C. Current is applied for cutting the sphincter. D. Extraction of stone through the opened papilla. days after sphincterotomy (Fig. 6). In 152 patients, we observed spontaneous passage of stones at the follow-up E R C P examination performed 1 week af-
188 36 152 306 225 81 29
ter sphincterotomy. In 81 patients, stones still present at the follow-up ERCP were extracted with the Dormia basket catheter. Residual stones that could not be extracted endoscopically were found in 29 patients and required surgical removal. Our results of endoscopic sphincterotomy in patients with choledocholithiasis are summarized in Table 2. Follow-up E R C P examination performed between 1 and 3 years after sphincterotomy in 188 patients showed the p e r m a n e n c e of the slit-like or rounded opening at the papilla of Vater. Recurrent stenosis of the sphincterotomy opening was not encountered. T w o patients experienced recurrence of stones, which were r e m o v e d endoscopically.
Complications Complications consisted of bleeding, retroperitoneal bile leakage, pancreatitis, cholangitis, and instrumental injury. T h e y occurred in 36 patients (6.9%) and were inconsequential in o v e r 2/3 of the instances. H o w e v e r , complications in 10 pa-
Fig. 4. Spontaneous passage of a common bile duct stone immediately after sphincterotomy. In (A) the 12 • 28 mm stone is in a supra-ampullary position in the common bile duct. In (B), after sphincterotomy, the stone is in the jejunum (arrow) and the common bile duct is filled homogeneously. tients (1.9%) required an emergency operation and resulted in 5 fatalities for a mortality rate of 1% (Table 3). Discussion Endoscopic sphincterotomy was successfully accomplished in 523 of 562 patients, an overall success rate of 93%. This is a higher success rate than that of diagnostic cannulation of the bile ducts for ERCP, which has been only 84% in our experience. The biliary stasis anddilatation of the c o m m o n bile
duct in patients selected for sphincterotomy create better anatomical conditions for cannulation. Among the several indications for endoscopic sphincterotomy, an obvious one is c o m m o n bile duct stones in patients who were subjected previously to cholecystectomy. Choledocholithiasis with obstructive jaundice in high-risk patients who have not had a cholecystectomy is also considered an indication for endoscopic treatment. In our experience, after relief of the jaundice, the cholecystolithiasis has not caused complaints. Two patients developed cholecystitis after sphincterotomy, which
Table 3. Complications of endoscopic sphincterotomy in 523 patients.
Complication
Number of patients
Emergency laparotomy required
Mortality
Bleeding Retroperitoneal perforation Pancreatitis Cholangitis with impacted stone Impacted Dormia basket Total
11 8 5 9 3 36 (6.9%)
1 1 1 5 2 10 (1.9%)
0 0 1 4 0 5 (1.0%)
Fig. 5. Stone extraction with the Dormia basket catheter. was controlled by antibiotics. Long tube-shaped stenosis of the common bile duct, simultaneous alteration of the proximal segments of the bile duct, serious coagulation disorders, and acute pancreatitis are contraindications to endoscopic sphincterotomy. Certainly, the size of the calculi influences the likelihood of complications. However, absolute criteria for calculus size cannot be established. What is decisive is the relationship between the size of the calculus and the possible length of the sphincterotomy, which can be estimated on the basis of endoscopic and radiological findings [13]. On the one hand, we have observed impaction of a relatively small stone that required surgery, while on the other hand, we have seen spontaneous passage of a 26 x 38 mm stone after a 35 mm long sphincterotomy (Fig. 6). We do not consider advanced age, cholangitis, chronic pancreatitis, gastric resection with Billroth II-type anastomosis, or juxtapapillary duodenal diverticula to be contraindications. The tactical approach to stone removal differs in several groups performing endoscopic sphincterotomy [8-10, 12]. Although most calculi will spontaneously pass into the duodenum after sphincterotomy, it would appear that stone extraction following sphincterotomy is preferred if it can be easily accomplished. It completes the procedure for the
Fig. 6. In (A) stone measuring 26 x 38 mm (diameter of endoscope is 11 ram) is seen in the common bile duct. In (B) the large stone has passed spontaneously after endoscopic sphincterotomy and is no longer seen on the follow-up ERCP performed 1 week later.
462
World J. Surg. Vol. 2, No. 4, July, 1978
(Fig. 7) clearly demonstrate that endoscopic sphincterotomy is functionally of equal value to surgical sphincteroplasty [13]. All of the complications that have been observed following surgical sphincterotomy must be reckoned with when undertaking endoscopic sphincterotomy. Our experience and that of others [9, 12, 15] have clearly shown that, even if the sphincterotomy is performed with the greatest technical skill, complications are inevitable, Although endoscopic sphincterotomy eliminates the hazards of anesthesia, laparotomy, and duodenotomy, the risks of the procedure upon the papilla itself are identical with those of the surgical approach. As the experience of the endoscopist increases, the frequency of complications decreases. We have had no lethal complications in our last 200 endoscopic sphincterotomies. The widespread availability of endoscopic sphincterotomy, the increasing number of patients referred for this method of treatment, and the low morbidity and mortality rates suggest that endoscopic sphincterotomy has earned a firm place in modern biliary surgery.
R6sum~
Fig. 7. Duodenobiliary reflux of air 1 year after endoscopic sphincterotomy indicating permanent noncontractile stoma equivalent to sphincteroplasty. patient and avoids the serious complications of stone impaction, cholangitis, and septicemia. Jones [5] has defined sphincteroplasty as a surgical procedure that produces a terminal choledochoduodenostomy with a stoma equal in diameter to that of the largest part of the common bile duct. The stoma is noncontractile and permanent, since the sphincters are completely destroyed. Surgical sphincterotomy ablates only the distal part of the sphincters, and leaves some functioning sphincter still present. Endoscopists interchangeably use the terms papillotomy [8, 10, 11, 13, 14] and sphincterotomy [7, 12], both of which fail to express the true nature of the procedure. However, the pathophysiological changes occurring after endoscopic sphincterotomy allow certain well-defined conclusions to be drawn. The long-term reduction of pressure in the biliary system [14], the permanent wide stoma observed at subsequent endoscopic investigations, the vigorous drainage of injected radiopaque medium through the orifice, and the duodenobiliary reflux observed in 62% of cases
Les calculs chol6dociens oubli6s ou r6cidivants exigeaient, il y a peu temps encore, un traitement chirurgical. Mais la lithiase chol6docienne peut actuellement &re trait6e par endoscopie. Ce rapport d6crit la technique de la sphinct6rotomie endoscopique et les r6sultats obtenus chez 562 malades atteints de lithiase chol6docienne et trait6s au cours des 4 derni6res ann6es. La sphinct6rotomie endoscopique a 6t6 r6alis6e avec succ~s chez 523 patients (93%), dont 428 avec calculs oubli6s ou r6cidivants apr6s chol6cystectomie. Chez 95 malades ~t haut risque, atteints de lithiase v6siculaire ou chol6docienne, la sphinct6rotomie endoscopique a 6t6 faite pour lever l'obstruction biliaire. Dans 188 cas, les calculs ont 6t6 61imin6s spontan6ment apr6s sphinct6rotomie. Dans 306 cas, ils ont 6t6 extraits. Chez 29 patients, les calculs n'ont pas 6t6 61imin6s du chol6doque. Des complications ont 6t6 observ6es chez 36 malades (6.9%); elles ont consist6 en h6morragie, perforation r6trop6riton6ale, pancr6atite, angiocholite et enclavement des cap culs. Dans 10 cas (1.9%), ces complications ont exig6 une th6rapeutique chirurgicale d'urgence, avec 5 d6c~s (1%). Les bons r6sultats, la mortalit6 et la morbidit6 faibles d6montrent que la sphinct6rotomie endoscopique a sa place dans la chirurgie biliaire moderne.
L. Safrany: Endoscopic Sphincterotomy for Choledocholithiasis
References
1. Shein, C.J., Stern, W.Z., Jacobson, H.G.: The Common Bile Duct: Operative Cholangiography, Biliary Endoscopy and Choledocholithotomy. Springfield, II1., Charles C. Thomas, 1966 2. Shore, J.M., Berci, G.: Operative management of calculi in hepatic ducts. Am. J. Surg. 119:625, 1970 3. Mazzariello, R.M.: Transhepatic extraction of residual calculi in common bile duct. Surgery 75:338, 1974 4. Berk, J.E., Kaplan, A.A: Choledocholithiasis. In Gastroenterology, 3rd. ed., Vol. III, H.L. Bockus, editor. Philadelphia-London-Toronto, W.B. Saunders Co., 1976, pp. 843-864 5. Jones, S.A.: Sphincteroplasty (not sphincterotomy) in the treatment of biliary tract disease. Surg. Clin. North Am. 53:1123, 1973 6. Watkins, G.L.: Biliary tract operations in a rural surgical practise: a review of 350 operations. Am. J. Surg. 121:518, 1971 7. Classen, M., Demling, L.: Endoskopische Sphinkterotomie der Papilla Vateri und Steinextraktion aus dem Ductus choledochus. Dtsch. Med. Wochenschr. 99:496, 1974
463
8. Classen, M., Safrany, L.: Endoscopic papillotomy and removal of gall stones. Br. Med. J. 4:371, 1975 9. Safrany, L.: Duodenoscopic sphincterotomy and gallstone removal. Gastroenterology 72:338, 1977 10. Koch, H.: Endoscopic papillotomy. Endoscopy 7:89, 1975 11. Zimmon, D., Falkenstein, D.B., Kessler, R.E.: Endoscopic papillotomy for choledocholithiasis. N. Engl. J. Med. 293:1181, 1975 12. Classen, M., R6sch, W., Farthmann, E.H.: Therapeutic endoscopy of the upper gastrointestinal tract. In Progress in Gastroenterology, G.B.J. Glass, editor. New York, Grune & Stratton, Inc., 1977, pp. 945-965 13. Safrany, L.: Incision length in endoscopic papillotomy. In Endoscopic Papillotomy. Workshop 1976 In Munich, L. Demling, M. Classen, editors. Stuttgart, Thieme-Verlag, 1978 14. R6sch, W.: Manometric studies during ERCP and endoscopic papillotomy. Endoscopy 8:30, 1976 15. Classen, M., Wurbs, D., Hagem/Jller, F.: Complications of the endoscopic papillotomy. In Endoscopic Papillotomy. Workshop 1976 In Munich, L. Demling, M. Classen, editors. Stuttgart, Thieme-Verlag, 1978
Invited Commentary David S. Zimmon, M.D. Divisionof Gastroenterology,Manhattan Veterans Administration Hospital, New York, New York, U.S.A. Safrany's remarkable personal experience with transduodenal endoscopic sphincterotomy and extraction of common duct stones is the keystone of the rapid acceptance of this valuable technique since its introduction by Classen and Demling in 1974 [1]. The development of this technique in Germany, as orchestrated by L. Demling, has included the training of a working cadre, establishment of regional referral centers, collation and publication of results, and continued self-examination and improvement. The rapid development of endoscopic biliary surgery may serve as a model for the efficient application of advances in clinical science. Transduodenal endoscopic sphincterotomy should be considered as but one of a number of rapidly evolving endoscopic techniques for the diagnosis and management of disease in the biliary tract and pancreas. These are based on the remarkably precise definition of anatomy and pathology obtained through fiberoptic endoscopy and endoscopic retrograde cholangiopancreatography (ERCP).
Initially, endoscopic sphincterotomy was reserved for post-cholecystectomy patients at high risk for transabdominal surgery because of associated disease, advanced age, or technical problems such as multiple prior biliary explorations. Consequently, the 1% mortality reported here in 523 patients and lack of mortality in 200 consecutive patients of whom 88% were over 50, 76% over 60, and 40% over 70 years of age is remarkable and deserves emphasis. After an initial favorable experience, indications were broadened to include highrisk patients with the gallbladder in situ where acute obstructive cholangitis or cholestasis could be relieved prior to cholecystectomy. In these patients, endoscopic sphincterotomy converts a high-risk emergency cholecystectomy and common duct exploration in an infected biliary tree, with the associated increased risk of intra-abdominal and wound infection, into an elective cholecystectomy with well-defined biliary anatomy where residual common duct stones, if present, can be flushed through
Transduodenal Endoscopic Sphincterotomy and Extraction of Bile Duct Stones Laszlo Safrany, M.D. GastroenterologicalClinic,Reinhard-Nieter-Hospital,Wilhelmshaven,WestGermany
Retained and recurrent common bile duct stones have required surgical treatment. Recent advances in endoscopy, however, have made possible endoscopic management of choledocholithiasis. This report describes the method of endoscopic sphincterotomy and the results in 562 patients with choledocholithiasis in whom the procedure was attempted during the past 4 years. Endoscopic sphincterotomy was successfully accomplished in 523 patients (93%). There were 428 patients with retained or recurrent common bile duct stones after cholecystectomy. In 95 high-risk patients with choledocholithiasis and cholelithiasis, endoscopic sphincterotomy was carried out to relieve jaundice. In 188 patients the stones passed spontaneously after sphincterotomy. In 306 patients, the stones were extracted. Residual stones remained in 29 patients. Complications consisting of bleeding, retroperitoneai perforation, pancreatitis, cholangitis, and stone impaction occurred in 36 patients (6.9%). In 10 patients (1.9%), complications made emergency surgery necessary and resulted in 5 deaths for a mortality rate of 1%. The good results, low morbidity, and low mortality of endoscopic sphincterotomy support the suggestion that this method of treatment has earned a firm place in modern biliary surgery.
techniques for exploration of the ampulla of Vater and cannulation of the common bile duct established the basis for therapeutic procedures in this region [7-12]. Endoscopic sphincterotomy of the papilla of Vater is being increasingly applied in the therapy of biliary diseases. In the Federal Republic of Germany, endoscopic sphincterotomy has become an established and accepted form of treatment, and experience with over 2,000 such procedures has been recorded. Use of endoscopic sphincterotomy is now spreading throughout the world [11].
Material and M e t h o d s
Selection of Patients Between May, 1974 and March, 1978, there were 562 patients with choledocholithiasis considered for endoscopic sphincterotomy. The procedure was successfully performed in 523 patients, a success rate of 93%. There were 428 patients with retained or recurrent common bile duct stones after cholecystectomy. In 95 elderly, high-risk patients, endoscopic sphincterotomy was performed to relieve choledocholithiasis with jaundice; many of these patients had associated stones in the gallbladder. The male-to-female ratio was 158:365. The age of the patients ranged from 14 to 89 years, with a mean of 66 years (Table 1). The youngest patient, who was 14 years of age, had severe congenital heart disease that required implantation of an artificial heart valve. A bilirubin stone that was probably caused
In spite of intraoperative cholangiography [1, 2], choledochoscopy [1, 2], and methods for nonoperative extraction of retained common bile duct stones in the early postoperative period after cholecystectomy [3], choledocholithiasis is still a common disease requiring surgery [4, 5]. The morbidity and mortality of choledocholithotomy is not negligible [4], and both tend to rise with advancing age [4, 6]. The development of diagnostic endoscopic Reprint requests: Professor Dr. L. Safrany, ReinhardNieter-Krankenhaus, D-2940 Wilhelmshaven, West Germany.
9 457
0364-2313/78/0002-0457 $01.60 Soci6t6 lnternationale de Chirurgie
458
World J. Surg. Vol. 2, No. 4, July, 1978
Table 1. Age distribution of 523 patients who underwent successful endoscopic sphincterotomy. Age (years)*
Number of patients
11-20
1
21-30 31-40 41-50 51-60 61-70 71-80 81-90
4 14 36 70 188 171 39
*Mean age was 66 years.
by us [9]. This is a wire drawn through the catheter used for papillary cannulation (Fig. 1). The distal end of the wire is fixed to the tip of the catheter and when it is pulled, the tip of the catheter bends so that a segment of the wire separates from the catheter. The saw-like wire can be used as a cautery. The energy source was an Olympus PSD 3 diathermy unit. The mixed cutting and coagulating current was used for sphincterotomy, at an intensity of grade 3 on the scale. The Dormia basket catheter was used for extraction of stones, just as it has been used for extraction of calculi through a T-tube fistula tract [3].
Technique of Sphincterotomy
Fig. 1. High frequency diathermy sphincterotome. by hemolysis produced obstruction of the common bile duct and jaundice. The common duct stone was removed endoscopically.
The first step of the procedure is the selective retrograde cannulation of the biliary tract and injection of a radiopaque medium for x-rays (ERCP). After having observed the ampulla of Vater and clarified the anatomy of the biliary system, the sphincterotome is advanced into the bile duct and its position is established by fluoroscopy. The sphincterotome modified by us [9] has a metal tip which is easily discernible under the fluoroscope (Fig. 2). The sphincterotome is then drawn back under visual control, to the point where the proximal end of the free portion of the wire is just outside the papilla. The direction of the incision should be upwards at the 10 or 11 o'clock position when facing the papilla. The average length of the incision is 17 mm [131. Removal of common bile duct stones is undertaken with the Dormia basket catheter. Under fluoroscopic control, the closed catheter is advanced beyond the calculi, then the basket is opened, and an attempt is made to capture the stone and remove it from the bile duct. The captured stone can be pulled out of the duodenum together with the endoscope. Figure 3 shows the procedure diagrammatically.
Results
Removal of Stones Instruments Olympus JF-B2 and JF-B3 fiberduodenoscopes with an Olympus CLX light source were used for diagnostic cannulation of the ampulla of Vater and endoscopic retrograde cholangiopancreatography (ERCP). The sphincterotome consisted of a snare developed by Demling and Classen [7] and modified
In 36 patients, stones were spontaneously expelled into the duodenum immediately following sphincterotomy (Fig. 4). In 225 patients, the stones were extracted with the Dormia basket catheter immediately after sphincterotomy (Fig. 5). In patients with multiple stones and those in whom extraction of stones could not be accomplished easily, spontaneous passage of the stones was expected within a few
L. Safrany: Endoscopic Sphincterotomy for Choledocholithiasis
459
Fig. 2. False position of sphincterotome. In (A) the metal tip is in the main pancreatic duct. In (B) the sphincterotome is in the correct position in the common bile duct.
A.
B.
Table 2. Results of endoscopic sphincterotomy in 523 patients with choledocholithiasis. Spontaneous passage of stones Immediately after sphincterotomy Within 1 week after sphincterotomy Stone extraction Immediately after sphincterotomy 1 week after sphincterotomy Residual stones
C.
D.
Fig. 3. Diagram of steps in endoscopic sphincterotomy. A. Sphincterotome is inserted in closed position into the common bile duct. B. The proximal part of the bended wire appears just outside the papilla. C. Current is applied for cutting the sphincter. D. Extraction of stone through the opened papilla. days after sphincterotomy (Fig. 6). In 152 patients, we observed spontaneous passage of stones at the follow-up E R C P examination performed 1 week af-
188 36 152 306 225 81 29
ter sphincterotomy. In 81 patients, stones still present at the follow-up ERCP were extracted with the Dormia basket catheter. Residual stones that could not be extracted endoscopically were found in 29 patients and required surgical removal. Our results of endoscopic sphincterotomy in patients with choledocholithiasis are summarized in Table 2. Follow-up E R C P examination performed between 1 and 3 years after sphincterotomy in 188 patients showed the p e r m a n e n c e of the slit-like or rounded opening at the papilla of Vater. Recurrent stenosis of the sphincterotomy opening was not encountered. T w o patients experienced recurrence of stones, which were r e m o v e d endoscopically.
Complications Complications consisted of bleeding, retroperitoneal bile leakage, pancreatitis, cholangitis, and instrumental injury. T h e y occurred in 36 patients (6.9%) and were inconsequential in o v e r 2/3 of the instances. H o w e v e r , complications in 10 pa-
Fig. 4. Spontaneous passage of a common bile duct stone immediately after sphincterotomy. In (A) the 12 • 28 mm stone is in a supra-ampullary position in the common bile duct. In (B), after sphincterotomy, the stone is in the jejunum (arrow) and the common bile duct is filled homogeneously. tients (1.9%) required an emergency operation and resulted in 5 fatalities for a mortality rate of 1% (Table 3). Discussion Endoscopic sphincterotomy was successfully accomplished in 523 of 562 patients, an overall success rate of 93%. This is a higher success rate than that of diagnostic cannulation of the bile ducts for ERCP, which has been only 84% in our experience. The biliary stasis anddilatation of the c o m m o n bile
duct in patients selected for sphincterotomy create better anatomical conditions for cannulation. Among the several indications for endoscopic sphincterotomy, an obvious one is c o m m o n bile duct stones in patients who were subjected previously to cholecystectomy. Choledocholithiasis with obstructive jaundice in high-risk patients who have not had a cholecystectomy is also considered an indication for endoscopic treatment. In our experience, after relief of the jaundice, the cholecystolithiasis has not caused complaints. Two patients developed cholecystitis after sphincterotomy, which
Table 3. Complications of endoscopic sphincterotomy in 523 patients.
Complication
Number of patients
Emergency laparotomy required
Mortality
Bleeding Retroperitoneal perforation Pancreatitis Cholangitis with impacted stone Impacted Dormia basket Total
11 8 5 9 3 36 (6.9%)
1 1 1 5 2 10 (1.9%)
0 0 1 4 0 5 (1.0%)
Fig. 5. Stone extraction with the Dormia basket catheter. was controlled by antibiotics. Long tube-shaped stenosis of the common bile duct, simultaneous alteration of the proximal segments of the bile duct, serious coagulation disorders, and acute pancreatitis are contraindications to endoscopic sphincterotomy. Certainly, the size of the calculi influences the likelihood of complications. However, absolute criteria for calculus size cannot be established. What is decisive is the relationship between the size of the calculus and the possible length of the sphincterotomy, which can be estimated on the basis of endoscopic and radiological findings [13]. On the one hand, we have observed impaction of a relatively small stone that required surgery, while on the other hand, we have seen spontaneous passage of a 26 x 38 mm stone after a 35 mm long sphincterotomy (Fig. 6). We do not consider advanced age, cholangitis, chronic pancreatitis, gastric resection with Billroth II-type anastomosis, or juxtapapillary duodenal diverticula to be contraindications. The tactical approach to stone removal differs in several groups performing endoscopic sphincterotomy [8-10, 12]. Although most calculi will spontaneously pass into the duodenum after sphincterotomy, it would appear that stone extraction following sphincterotomy is preferred if it can be easily accomplished. It completes the procedure for the
Fig. 6. In (A) stone measuring 26 x 38 mm (diameter of endoscope is 11 ram) is seen in the common bile duct. In (B) the large stone has passed spontaneously after endoscopic sphincterotomy and is no longer seen on the follow-up ERCP performed 1 week later.
462
World J. Surg. Vol. 2, No. 4, July, 1978
(Fig. 7) clearly demonstrate that endoscopic sphincterotomy is functionally of equal value to surgical sphincteroplasty [13]. All of the complications that have been observed following surgical sphincterotomy must be reckoned with when undertaking endoscopic sphincterotomy. Our experience and that of others [9, 12, 15] have clearly shown that, even if the sphincterotomy is performed with the greatest technical skill, complications are inevitable, Although endoscopic sphincterotomy eliminates the hazards of anesthesia, laparotomy, and duodenotomy, the risks of the procedure upon the papilla itself are identical with those of the surgical approach. As the experience of the endoscopist increases, the frequency of complications decreases. We have had no lethal complications in our last 200 endoscopic sphincterotomies. The widespread availability of endoscopic sphincterotomy, the increasing number of patients referred for this method of treatment, and the low morbidity and mortality rates suggest that endoscopic sphincterotomy has earned a firm place in modern biliary surgery.
R6sum~
Fig. 7. Duodenobiliary reflux of air 1 year after endoscopic sphincterotomy indicating permanent noncontractile stoma equivalent to sphincteroplasty. patient and avoids the serious complications of stone impaction, cholangitis, and septicemia. Jones [5] has defined sphincteroplasty as a surgical procedure that produces a terminal choledochoduodenostomy with a stoma equal in diameter to that of the largest part of the common bile duct. The stoma is noncontractile and permanent, since the sphincters are completely destroyed. Surgical sphincterotomy ablates only the distal part of the sphincters, and leaves some functioning sphincter still present. Endoscopists interchangeably use the terms papillotomy [8, 10, 11, 13, 14] and sphincterotomy [7, 12], both of which fail to express the true nature of the procedure. However, the pathophysiological changes occurring after endoscopic sphincterotomy allow certain well-defined conclusions to be drawn. The long-term reduction of pressure in the biliary system [14], the permanent wide stoma observed at subsequent endoscopic investigations, the vigorous drainage of injected radiopaque medium through the orifice, and the duodenobiliary reflux observed in 62% of cases
Les calculs chol6dociens oubli6s ou r6cidivants exigeaient, il y a peu temps encore, un traitement chirurgical. Mais la lithiase chol6docienne peut actuellement &re trait6e par endoscopie. Ce rapport d6crit la technique de la sphinct6rotomie endoscopique et les r6sultats obtenus chez 562 malades atteints de lithiase chol6docienne et trait6s au cours des 4 derni6res ann6es. La sphinct6rotomie endoscopique a 6t6 r6alis6e avec succ~s chez 523 patients (93%), dont 428 avec calculs oubli6s ou r6cidivants apr6s chol6cystectomie. Chez 95 malades ~t haut risque, atteints de lithiase v6siculaire ou chol6docienne, la sphinct6rotomie endoscopique a 6t6 faite pour lever l'obstruction biliaire. Dans 188 cas, les calculs ont 6t6 61imin6s spontan6ment apr6s sphinct6rotomie. Dans 306 cas, ils ont 6t6 extraits. Chez 29 patients, les calculs n'ont pas 6t6 61imin6s du chol6doque. Des complications ont 6t6 observ6es chez 36 malades (6.9%); elles ont consist6 en h6morragie, perforation r6trop6riton6ale, pancr6atite, angiocholite et enclavement des cap culs. Dans 10 cas (1.9%), ces complications ont exig6 une th6rapeutique chirurgicale d'urgence, avec 5 d6c~s (1%). Les bons r6sultats, la mortalit6 et la morbidit6 faibles d6montrent que la sphinct6rotomie endoscopique a sa place dans la chirurgie biliaire moderne.
L. Safrany: Endoscopic Sphincterotomy for Choledocholithiasis
References
1. Shein, C.J., Stern, W.Z., Jacobson, H.G.: The Common Bile Duct: Operative Cholangiography, Biliary Endoscopy and Choledocholithotomy. Springfield, II1., Charles C. Thomas, 1966 2. Shore, J.M., Berci, G.: Operative management of calculi in hepatic ducts. Am. J. Surg. 119:625, 1970 3. Mazzariello, R.M.: Transhepatic extraction of residual calculi in common bile duct. Surgery 75:338, 1974 4. Berk, J.E., Kaplan, A.A: Choledocholithiasis. In Gastroenterology, 3rd. ed., Vol. III, H.L. Bockus, editor. Philadelphia-London-Toronto, W.B. Saunders Co., 1976, pp. 843-864 5. Jones, S.A.: Sphincteroplasty (not sphincterotomy) in the treatment of biliary tract disease. Surg. Clin. North Am. 53:1123, 1973 6. Watkins, G.L.: Biliary tract operations in a rural surgical practise: a review of 350 operations. Am. J. Surg. 121:518, 1971 7. Classen, M., Demling, L.: Endoskopische Sphinkterotomie der Papilla Vateri und Steinextraktion aus dem Ductus choledochus. Dtsch. Med. Wochenschr. 99:496, 1974
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8. Classen, M., Safrany, L.: Endoscopic papillotomy and removal of gall stones. Br. Med. J. 4:371, 1975 9. Safrany, L.: Duodenoscopic sphincterotomy and gallstone removal. Gastroenterology 72:338, 1977 10. Koch, H.: Endoscopic papillotomy. Endoscopy 7:89, 1975 11. Zimmon, D., Falkenstein, D.B., Kessler, R.E.: Endoscopic papillotomy for choledocholithiasis. N. Engl. J. Med. 293:1181, 1975 12. Classen, M., R6sch, W., Farthmann, E.H.: Therapeutic endoscopy of the upper gastrointestinal tract. In Progress in Gastroenterology, G.B.J. Glass, editor. New York, Grune & Stratton, Inc., 1977, pp. 945-965 13. Safrany, L.: Incision length in endoscopic papillotomy. In Endoscopic Papillotomy. Workshop 1976 In Munich, L. Demling, M. Classen, editors. Stuttgart, Thieme-Verlag, 1978 14. R6sch, W.: Manometric studies during ERCP and endoscopic papillotomy. Endoscopy 8:30, 1976 15. Classen, M., Wurbs, D., Hagem/Jller, F.: Complications of the endoscopic papillotomy. In Endoscopic Papillotomy. Workshop 1976 In Munich, L. Demling, M. Classen, editors. Stuttgart, Thieme-Verlag, 1978
Invited Commentary David S. Zimmon, M.D. Divisionof Gastroenterology,Manhattan Veterans Administration Hospital, New York, New York, U.S.A. Safrany's remarkable personal experience with transduodenal endoscopic sphincterotomy and extraction of common duct stones is the keystone of the rapid acceptance of this valuable technique since its introduction by Classen and Demling in 1974 [1]. The development of this technique in Germany, as orchestrated by L. Demling, has included the training of a working cadre, establishment of regional referral centers, collation and publication of results, and continued self-examination and improvement. The rapid development of endoscopic biliary surgery may serve as a model for the efficient application of advances in clinical science. Transduodenal endoscopic sphincterotomy should be considered as but one of a number of rapidly evolving endoscopic techniques for the diagnosis and management of disease in the biliary tract and pancreas. These are based on the remarkably precise definition of anatomy and pathology obtained through fiberoptic endoscopy and endoscopic retrograde cholangiopancreatography (ERCP).
Initially, endoscopic sphincterotomy was reserved for post-cholecystectomy patients at high risk for transabdominal surgery because of associated disease, advanced age, or technical problems such as multiple prior biliary explorations. Consequently, the 1% mortality reported here in 523 patients and lack of mortality in 200 consecutive patients of whom 88% were over 50, 76% over 60, and 40% over 70 years of age is remarkable and deserves emphasis. After an initial favorable experience, indications were broadened to include highrisk patients with the gallbladder in situ where acute obstructive cholangitis or cholestasis could be relieved prior to cholecystectomy. In these patients, endoscopic sphincterotomy converts a high-risk emergency cholecystectomy and common duct exploration in an infected biliary tree, with the associated increased risk of intra-abdominal and wound infection, into an elective cholecystectomy with well-defined biliary anatomy where residual common duct stones, if present, can be flushed through
