Cardiovasc lntervent Radiol tl992) 15:351-355
CardioUascular andInterventional
Rad gy
9 Springer-Verlag New York Inc. 1992
Biliary System Malignant Biliary Obstruction: Treatment with Self-Expandable Stainless Steel Endoprosthesis Erich K. Salomonowitz,~ Andreas Adam,: F r a n c e s c o Antonucci,~ Gerd S t u c k m a n n . and Christoph L. Zollikofer ~ tDepartment of Radiology, Kantonsspital Wmterthur. Switzerland: and -'Department of Diagnostic Radiology, Royal Postgraduate Medical School. Hammersmith Ho,',pital, London, England
Abstract. Metal e n d o p r o s t h e s e s of the Wallstent type were successfully inserted percutaneously and endoscopicatly in 80 consecutive patients with malignant obstructive biliary stenoses, who were followed for up to 18 months, The indication for treatment was jaundice due to malignant biliary obstruction. R e p e a t radiological investigations were performed if the patient had s y m p t o m s suggesting stent occlusion. After stent implantation. 88% of patients d e m o n s t r a t e d a serum bilirubin decrease by more than 50%. We o b s e r v e d a 15% rate of serious complications, including a 10% rate of chotangitis with septicemia. There were no cases of stent migration or occlusion due to encrustation of bile. Recurrent jaundice occurred in 17.5% of patients due to progressive t u m o r growth after 3-10 months. In 5 of these patients, t u m o r o v e r g r o w t h was redilated and/ or restented. O f the 80 patients, 34% are alive after 2-12 months (mean: 242 days): of these, two-thirds are free of jaundice, Sixty-six percent of patients died between 3 days and 1.5 years (mean: 133 days), Although a u t o p s y investigations revealed the possibility of t u m o r growth onto the inner surface of the stent, through the mesh of the endoprosthesis, no stent occlusion by t u m o r ingrowth into the lumen occurred. Self-expandable stainless steel endoprostheses provide good palliation in patients with malignant obstructive jaundice.
Key words: Bile d u c t s - - I n t e r v e n t i o n a l procedures N N e o p l a s m s N Prostheses - - Stenoses, obstructions
Address reprint requests to: Erich K. Salomonowitz. M.D., Central Department of Radiology, A.o. KH St.Polten, Probst F/~hrer
Str. 4, A-3100 St.Potten. Austria
Biliary e n d o p r o s t h e s e s are a c c e p t e d alternatives to surgical palliation of malignant obstructive jaundice [1-4]. Short biliary stenoses, isolated stenoses due to previous surgical interventions, and inoperable malignant conditions m a y be considered absolute indications for p e r c u t a n e o u s stent treatment [5, 6]. Self-expandable biliary e n d o p r o s t h e s e s achieve satisfactory internal drainage of the biliary tree without the physical and psychological problems associated with external catheters and are less prone to migration or occlusion by sludge when c o m p a r e d with internal stents, P e r c u t a n e o u s insertion is less traumatic because self-expandable e n d o p r o s t h e s e s can be inserted with catheters of relatively small caliber but when released, expand to a large lumen resulting in sufficient drainage. We have used Watlstent e n d o p r o s t h e s e s (Medinvent SA, Lausanne, Switzerland) in 80 consecutive patients o v e r a period of 48 m o n t h s in our two institutions in Winterthur, Switzerland and L o n d o n , England. Here, we analyze our results.
Patients and Methods The 80 patients ranged in age from 22 to 93 years (mean 69 years). In 53 patients (66%). the level of obstruction was at the liver hilum. The most common histological diagnosis and indication for stenting was obstruction due to cholangiocarcinoma (33 patients, 41%). Other diagnoses included pancreatic, gallbladder, and hepatocellular carcinoma: 12 patients 115,QI had metastases at the liver hilum from gastric or colonic carcinoma. The indication for treatment was jaundice in all patmnts and the diagnosis was based on blopsy and radiological appearance of the stenotic lesion. Li~er thnction tests, including serum bilirubin levels, were used to monitor the success of stenting. Repeat radiological investigations were performed only if the patient had symptoms suggesting stem occlusion. Otherwise. patients were seen at intervals of several months S~xty-one patients 17697) were stented after percutaneous
352
E.K Salomonowltz et al." Malignant Blhary O b s t r u c u o n guidewire [4 m) which should be placed deep into the hver periphery via the papilla by the endoscopist. T h e next step includes the insertion of the stent possibly with previous dilatation of the stenosis, if deemed necessary. W h a t e v e r t e c h m q u e ms applied, the distal end of the stem m a y be allowed to project into the d u o d e n u m through the ampulla of Vater.
Results
Clinical
A Fig. 1. A 55-year-old patient with pancreatic carcinoma and liver m e t a s t a s e s . A PTC s h o w s high-grade steno~i~ of the c o m m o n bile duct. B After primary insertion of two overlapping 10-ram Wallstents m the s a m e session as the PTC, there is free t]ow o f contrast material into the d u o d e n u m . The distal end of the stent lies in the papdla.
t r a n s h e p a n c catheter drainage (PTCD) which was left m place for 1-18 days Imean 5.3 days). With our increasing experience, we were able to stent 13 patients m one session, without preceding P T C D (Fig. ~). Six 5tents were imphmted retrograde endoscop~cally 1Fig. 2t. Before i n s e m o n of a stent, the strictures were dilated v,'~th a high-pressure, low-profile angioplasty balloon. Most of the endop r o s t h e s e s did not e x p a n d fully after thexr release and were usually dilated in sitet. Despite potential friction during insertion or withdrawal of the dilatation balloon, no displacement of the e n d o p r o s t h e s e s occurred. In our experience, the stents could not be overdistended, and they reached their maxanal dmmeters within 10 days by t h e m s e l v e s . T h u s , the precise final length of the stent could not be forseen before ~ts maximal dflatatton. After successful d e p l o y m e n t of the stents, temporary external catheters were left m place for 24 h. With increasing experience, primary stent implants were performed without this safety m e a s u r e and without further c o m p l i c a t m n s . The external catheter ~ a s used to obtain a cholangiogram the next day to check satisfactory positron of the stent and the extent o f bile duct dilatatmn. If necesbary, a second stent could then be inserted overlapping with the first one or in Y-form. H o w e v e r , s e c o n d a r y stenting on the day following the primary procedure was performed only once, Sixteen patients (20%) needed more than one stem. In the other 64 patients, only the right or the left main hepatic ducts were drained. In 13 patients, one stent was not sufficient to bypass the malignant stricture and either two overlapping endoprostheses were n e c e s s a r y or the two s t e m s had to be placed in Y- or Hform, either with right and left approach or via sole left or sole right approach only {Fig, 3). Three patients received three stents and in total, 99 stents were implanted. Technical details of the stent have been published e l s e w h e r e [7-9]. The technique of stent d e p l o y m e n t is straightforward, as also described in other c o m m u n i c a t i o n s in Part I of this Special Issue IVol. 15 No. 5). Perc u t a n e o u s stent implantation is performed in a step-by-step procedure. Stent e x p a n s i o n m a y be followed with plain radiographs or sonography, Sonographically, the stent can be seen as a dense band and s o m e t i m e s e v e n the wire m e s h can be appreciated. Endoscopic stent placement necessitates a long exchange
In 70 patients ~88%) the serum bilirubin level decreased by more than 50~. In 5 patients (6%) the bilirubin level fell to normal (3-17/,mol/L) before hospital discharge. In numbers, bilirubin levels ranged from 44 to 614/xmot/L (mean 3121 at hospital admission, from 31 to 521/,mol/L {mean 271) before stent placement, and from 8 to 1 I0/,mol/L (mean 67) at time of hospital discharge. In 5 patients 16%) the bitirubin level did not decrease due to liver failure or liver metastases.
Tectmical Percutaneous insertions of the drainage catheters and placement of the self-expandable endoprostheses were successful in all patients. In London, the stent could not be released completely in 6 patients and had to be removed by withdrawing the introducing catheter through a 9F sheath which prevented damage to the biliary tree. Following removal of the half-open stent, another endoprosthesis was inserted. This technical problem was not encountered in Switzerland. Changes in the design and technical composition of the plastic rolling membrane eliminated these problems in subsequent patients in England.
Complications In the series of 80 consecutive patients, we observed 10% minor complications in the form of one subcapsular liver hematoma (no further treatment), one subcutaneous bleeding (stopped after insertion of an 8.3F catheter), one hydroptic gallbladder due to obstruction of the cystic duct (relieved by itself), one malposition of the first stent (prompting the insertion of a second stent), one endoprosthesis release far into the duodenum (no ill-effects), one cephalad displacement of an endoprosthesis by a partially deflated angioplasty balloon (a second stent overlapping the first ensured adequate biliary drainage), and one case of blood entering the biliary tree following puncture of a subcutaneous blood vessel (no further treatment). One patient had a small subcutaneous abscess at the catheter entry site.
E.K. Salomonowltz et at." Malignant Biliary Obstruction
353
C
Fig. 2. A 67-year-old patient with pancreatic carcinoma. A ERCP s h o w s subtotal occlusion of the c o m m o n bile duct with massive proximal dilatation or" the bde ducts. B Stent ts mounted on the introducing catheter being placed through the endoscope into the c o m m o n bite duct. Lead markers delineate proximal and distal end of constrained stent ~arrows). C Released but not yet fully expanded stent. D Balloon dilatation for better stent expansion. E The stent is now well expanded. Most of the contrast material has s p o n t a n e o u s l y drained from the bile ducts. There is air m the bile ducts b e c a u s e the distat end o f the stent was placed just at the papilla.
14 patients (17.5%) due to progressive tumor growth after 3-10 months, In 5 of these patients, recurrent jaundice was seemingly due to tumor overgrowth at the proximal mouth of the stent, prompting percutaneous reentry for balloon dilatation of the tumor and/or placement of a second stent. One patient had endoscopic placement of a plastic stent.
Patient Survival
Serious complications included 7 cases of septicemia secondary to cholangitis (treated with antibiotics), 1 cholecystitis (antibiotics), I intrahepatic hematoma (no treatment), 1 bhort-term (1 day) biliovenous fistula, and 1 leakage of bile via the transhepatic tract through the cutaneous puncture for a few days following stent introduction. There were no cases of prolonged hemobilia due to damage of hepatic blood vessels. One cholecystitis occurred with hydrops of the gallbladder and prompted a percutaneous cholecystostomy at 10 days and surgical cholecystectomy another 2 weeks later. In this patient, the hydroptic gallbladder enlargement was possibly related to the stent occluding the cystic duct. This was the only complication necessitating an operative corrective action. The rate of serious complications was 15% (12 cases).
Stent Patency There were no cases of stent migration or occlusion due to bile sludge. Recurrent jaundice occurred in
There was no procedure-related mortality. The 30day mortality rate was 6.25% (5 patients). Fifty-three patients (66%) died between 3 days and t.5 years (mean 133 days after stenting); 27 patients (34%) are still alive after 2-12 months (mean 242 days): 18 of the patients who are still alive (66%) are free of jaundice.
Autopsies Fifteen patients were autopsied. In 3, tumor tissue had grown through the wire mesh after 4-6 months without causing obstruction. In 2 patients, the tumor had grown over the proximal end of the stent without intruding into the stent. When the tumor had grown to the surface of the stented bile duct, debris of necrotic ceils was found at the surface and in the lumen. However, we did not see stent occlusion by tumor bulk ingrowth into the stent. Endoprostheses of patients surviving more than 6 months were found to be covered by fibrous tissue with a mucous coat. In 2 patients who died after more than 1 year, a complete coverage by mucosa was found.
354
E.K. Salomonowltz et al.: Mahgnant Blhary Obstruction Discussion
7jr
9
,
~.~
B
Fig, 3, A 60-year-old female patient with obstructive jaundice from cholanglocarcinoma (Ktatzkin tumor). A Percutaneous transpapfltary internal/external drainage shows tight s~enosls at the bifurcation involving two major right hepatic ducts. No opaclfication of the left hepatic duct could be seen. B A 10-ram stent was placed on the right side and a safety drain was left for 1 day. Percutaneous cholangiogram demonstrates a stenotic inflow of a cranial right hepatic duct into the stented common hepatic duct, whereas the left duct again is not opacified. C Although bilirubin levels fell, pruritus persisted becau.~e the left hepatic duct was also drained. The figure shows balloon dilatation of the hepatic bifurcation over a guidewire advanced through the first stent into the duodenum. D A second 6-ram stent was placed from the left with good drainage through both stents. E The patient survived with normal bilirubin levels for 4 months Autopsy specimen shows the left-sided stent Iwhite arrows) passing through the dilated mesh into the right-sided stent (black arrows). Both stents are widely patent (cut open).
Biliary endoprostheses of the self-expanding wire mesh design offer specific advantages when compared with plastic stents [4, 8, 10]. Specifically, the small size for introduction of the Wallstent (F-7) allows the deployment of the endoprosthesis via a relatively small tract through the liver. The endoprosthesis expands to a large lumen of6-10 mm and dislocation is very unlikely. The wire mesh allows stenting of multiple ducts. The stents may be placed parallel to each other or in a tandem fashion. We have even placed one stent through another by puncturing and dilating the mesh without ill effects. Within several months, mucosa will cover the inner surface of the stent with a natural lining. Colonization of the stent by bacteria may pose specific problems [1 I, 12]. In our patients, however, this seemingly was of no importance. Adequate bile flow minimizes the danger of local cholangitis. We have not registered patient discomfort, once the stent is in place. The complication rate is relatively low. Even if occlusion by tumor ingrowth or by bile encrustation occurs, a second balloon dilatation may be performed and even a second stent placed through the first. We have no definite answer as to what degree mucosal hyperplasia may occlude stents that are placed through malignant lesions. Although stent designs with fewer metal struts and less traumatic outward radial force may cause less mucosal reaction, a tighter mesh design hinders tumor ingrowth and a greater outward radial force may cause local tumor necrosis and thus prolong lumen patency. Experimental work presently concentrates on coated stents which might even incorporate local antitumor substances [13]. In our experience, aggressive stenting is indicated in malignant disease. To prevent tumor overgrowth we place multiple stents or stent multiple ducts. Endoscopic stents have advantages for distal common bile-duct lesions. With endoscopy, less pain and, possibly, fewer complications are to be anticipated and we employ this technique whenever possible. The Walfstent has some disadvantages~ First, the foreshortening of the stent depending on the degree of expansion; this may be important for stents to be released exactly at the papilla. The delicate stent is barely visible during deployment and high resolution fluoroscopic equipment should be used. Second, once the stent is in place, it is not exchangeable. Third, the metal endoprosthesis is expensive, especially when compared with conventional plastic biliary endoprostheses, which, when occluded, may be replaced by the endoscopist [3, 8]. Transpapillary placement of some of our stents did not cause any
E.K. Salomonow~tz et al . Mahgnant Bfliary Ob~tructlon
ill effects. Specifically, we could not demonstrate a rise of pancreatic enzymes, and no clinical pancreatitis occurred. One symptomatic superficial ulceration of the duodenal wall could be demonstrated at autopsy. One serious complication in the form of cholecystitis followed by hydrops of the gallbladder could have been caused by compression of the distal cystic duct by the relatively large caliber of the endoprosthesis and its outward radial force. The valve of Heister has a spiral form to keep the cystic duct open, and cystic duct occlusions usually occur by impacted stones or local inflammatory or desmoplastic reaction (R. Greening, personal communication). In our patient, the cholecystitis occurred within 48 h after stent placement, and the development of inflammatory reaction is very unlikely. Thus, we assume that by an error during stent placement, the proximal end of the stent with its spiculated struts had tacked down the cystic duct lumen. In conclusion, large bore self-expandable stainless steel biliary endoprostheses seem to provide a better long-term patency when compared with conventional stents and cause less discomfort for the patient. The small caliber of the constrained stent allows an easy passage through the liver and decreases the rate of possible complications. With increasing experience, one-step transhepatic procedures will become more frequent resulting in a shorter patient hospital stay and lower costs. AU, no~,'ledgmet~t. This work wab supported by the LudwlgBoltzmann-lnstitute Vienna.
for
Radlotoglcal
Tumor
Diagno>is,
355 References
1. Coons HG (1989) Self-expanding stainless steel biliary stents. Radiology 170:979-983 2. Gitlams A, Dick R, Dooley JS, Wallsten H, EI-Dm A (1990) Self-expandable stainless steel braided endoprosthesis for biliary strictures. Radiology 174:137-140 3. Hmbregtse K, Cheng J, Coene PPLO. Fockens P, Tytgat GNJ I19891 Endoscopic placement of expandable metal stents for biliary strictures--A preliminary report on experience with 33 patients. Endoscopy 21.280-282 4. Irving JD, Adam A, Dick R, Dondelinger RF, Lunderquist A, Roche A tl989) Gianturco expandable metallic biliary stents: Results of a European clinical trial. Radiology 172:321-326 5. McLean GK, Burke DR 11989) Role of endoprostheses in the management of malignant biliary obstructmn. Radiology 170.961-967 6. Ro,,,Sl P, Bezzi M, Salvatori FM, Macmoni Francesca, Porcaro ML 11990) Recurrent benign biliary strictures" Management with self-expanding metallic stents. Radmlogy 175:661-665 7 Dick R, GIIlams A. Dooley JS, Hobbs KEF {19891 Stainless steel mesh stents for blliary strictures J lntervent Radiol 4:95-98 8. Neuhau~ H, Hagenmuller F, Gnebel M, Rotter M, Classen M 119901 Endoskopische und perkutane Implantatton setbstexpan-dlerender Endoprothesen bei biliaren Stenosen. Dtsch Med Wschr 115:1299-1306 9. Zollikofer CL, Largiader 1. Br0hlmann WF. Uhtschmld GK, Marty AH t 1988) Endovascular stentmg of veins and grafts: Prehmmary clinical experience. Radiology 167:707-712 10. Mueller PR, Ferruccl JT, Teplick SK, van Sonnenberg E, Haskin PH, Butch RJ. Papanicolaou N (1985) Blhary btent endoprosthe~is: Analysis of complications in 113 patients. Radiology 156:637-639 I1 Groen AKH. Out T, Hmbregtse K, Deizenne B, Hoek FJ~ Tytgat GNJ (1987) Characterization of the content of occluded bihary endopro~theses. Endoscopy 19:57-59 12 Leung JMV, Ling TKW. Kung JLS, Vallance-Owen J (1988l The rote of bacteria in the blockage of blllary stents. Gastromtest Endos 34:19-22 13 Roeren T, Brambs HJ, Richter GM. Kauffmann GW (19907 Coated balloon-expandable ~tent for percutaneous treatment of malignant biliary obstructton. Radiology 177(B):238-239
CardioUascular andInterventional
Rad gy
9 Springer-Verlag New York Inc. 1992
Biliary System Malignant Biliary Obstruction: Treatment with Self-Expandable Stainless Steel Endoprosthesis Erich K. Salomonowitz,~ Andreas Adam,: F r a n c e s c o Antonucci,~ Gerd S t u c k m a n n . and Christoph L. Zollikofer ~ tDepartment of Radiology, Kantonsspital Wmterthur. Switzerland: and -'Department of Diagnostic Radiology, Royal Postgraduate Medical School. Hammersmith Ho,',pital, London, England
Abstract. Metal e n d o p r o s t h e s e s of the Wallstent type were successfully inserted percutaneously and endoscopicatly in 80 consecutive patients with malignant obstructive biliary stenoses, who were followed for up to 18 months, The indication for treatment was jaundice due to malignant biliary obstruction. R e p e a t radiological investigations were performed if the patient had s y m p t o m s suggesting stent occlusion. After stent implantation. 88% of patients d e m o n s t r a t e d a serum bilirubin decrease by more than 50%. We o b s e r v e d a 15% rate of serious complications, including a 10% rate of chotangitis with septicemia. There were no cases of stent migration or occlusion due to encrustation of bile. Recurrent jaundice occurred in 17.5% of patients due to progressive t u m o r growth after 3-10 months. In 5 of these patients, t u m o r o v e r g r o w t h was redilated and/ or restented. O f the 80 patients, 34% are alive after 2-12 months (mean: 242 days): of these, two-thirds are free of jaundice, Sixty-six percent of patients died between 3 days and 1.5 years (mean: 133 days), Although a u t o p s y investigations revealed the possibility of t u m o r growth onto the inner surface of the stent, through the mesh of the endoprosthesis, no stent occlusion by t u m o r ingrowth into the lumen occurred. Self-expandable stainless steel endoprostheses provide good palliation in patients with malignant obstructive jaundice.
Key words: Bile d u c t s - - I n t e r v e n t i o n a l procedures N N e o p l a s m s N Prostheses - - Stenoses, obstructions
Address reprint requests to: Erich K. Salomonowitz. M.D., Central Department of Radiology, A.o. KH St.Polten, Probst F/~hrer
Str. 4, A-3100 St.Potten. Austria
Biliary e n d o p r o s t h e s e s are a c c e p t e d alternatives to surgical palliation of malignant obstructive jaundice [1-4]. Short biliary stenoses, isolated stenoses due to previous surgical interventions, and inoperable malignant conditions m a y be considered absolute indications for p e r c u t a n e o u s stent treatment [5, 6]. Self-expandable biliary e n d o p r o s t h e s e s achieve satisfactory internal drainage of the biliary tree without the physical and psychological problems associated with external catheters and are less prone to migration or occlusion by sludge when c o m p a r e d with internal stents, P e r c u t a n e o u s insertion is less traumatic because self-expandable e n d o p r o s t h e s e s can be inserted with catheters of relatively small caliber but when released, expand to a large lumen resulting in sufficient drainage. We have used Watlstent e n d o p r o s t h e s e s (Medinvent SA, Lausanne, Switzerland) in 80 consecutive patients o v e r a period of 48 m o n t h s in our two institutions in Winterthur, Switzerland and L o n d o n , England. Here, we analyze our results.
Patients and Methods The 80 patients ranged in age from 22 to 93 years (mean 69 years). In 53 patients (66%). the level of obstruction was at the liver hilum. The most common histological diagnosis and indication for stenting was obstruction due to cholangiocarcinoma (33 patients, 41%). Other diagnoses included pancreatic, gallbladder, and hepatocellular carcinoma: 12 patients 115,QI had metastases at the liver hilum from gastric or colonic carcinoma. The indication for treatment was jaundice in all patmnts and the diagnosis was based on blopsy and radiological appearance of the stenotic lesion. Li~er thnction tests, including serum bilirubin levels, were used to monitor the success of stenting. Repeat radiological investigations were performed only if the patient had symptoms suggesting stem occlusion. Otherwise. patients were seen at intervals of several months S~xty-one patients 17697) were stented after percutaneous
352
E.K Salomonowltz et al." Malignant Blhary O b s t r u c u o n guidewire [4 m) which should be placed deep into the hver periphery via the papilla by the endoscopist. T h e next step includes the insertion of the stent possibly with previous dilatation of the stenosis, if deemed necessary. W h a t e v e r t e c h m q u e ms applied, the distal end of the stem m a y be allowed to project into the d u o d e n u m through the ampulla of Vater.
Results
Clinical
A Fig. 1. A 55-year-old patient with pancreatic carcinoma and liver m e t a s t a s e s . A PTC s h o w s high-grade steno~i~ of the c o m m o n bile duct. B After primary insertion of two overlapping 10-ram Wallstents m the s a m e session as the PTC, there is free t]ow o f contrast material into the d u o d e n u m . The distal end of the stent lies in the papdla.
t r a n s h e p a n c catheter drainage (PTCD) which was left m place for 1-18 days Imean 5.3 days). With our increasing experience, we were able to stent 13 patients m one session, without preceding P T C D (Fig. ~). Six 5tents were imphmted retrograde endoscop~cally 1Fig. 2t. Before i n s e m o n of a stent, the strictures were dilated v,'~th a high-pressure, low-profile angioplasty balloon. Most of the endop r o s t h e s e s did not e x p a n d fully after thexr release and were usually dilated in sitet. Despite potential friction during insertion or withdrawal of the dilatation balloon, no displacement of the e n d o p r o s t h e s e s occurred. In our experience, the stents could not be overdistended, and they reached their maxanal dmmeters within 10 days by t h e m s e l v e s . T h u s , the precise final length of the stent could not be forseen before ~ts maximal dflatatton. After successful d e p l o y m e n t of the stents, temporary external catheters were left m place for 24 h. With increasing experience, primary stent implants were performed without this safety m e a s u r e and without further c o m p l i c a t m n s . The external catheter ~ a s used to obtain a cholangiogram the next day to check satisfactory positron of the stent and the extent o f bile duct dilatatmn. If necesbary, a second stent could then be inserted overlapping with the first one or in Y-form. H o w e v e r , s e c o n d a r y stenting on the day following the primary procedure was performed only once, Sixteen patients (20%) needed more than one stem. In the other 64 patients, only the right or the left main hepatic ducts were drained. In 13 patients, one stent was not sufficient to bypass the malignant stricture and either two overlapping endoprostheses were n e c e s s a r y or the two s t e m s had to be placed in Y- or Hform, either with right and left approach or via sole left or sole right approach only {Fig, 3). Three patients received three stents and in total, 99 stents were implanted. Technical details of the stent have been published e l s e w h e r e [7-9]. The technique of stent d e p l o y m e n t is straightforward, as also described in other c o m m u n i c a t i o n s in Part I of this Special Issue IVol. 15 No. 5). Perc u t a n e o u s stent implantation is performed in a step-by-step procedure. Stent e x p a n s i o n m a y be followed with plain radiographs or sonography, Sonographically, the stent can be seen as a dense band and s o m e t i m e s e v e n the wire m e s h can be appreciated. Endoscopic stent placement necessitates a long exchange
In 70 patients ~88%) the serum bilirubin level decreased by more than 50~. In 5 patients (6%) the bilirubin level fell to normal (3-17/,mol/L) before hospital discharge. In numbers, bilirubin levels ranged from 44 to 614/xmot/L (mean 3121 at hospital admission, from 31 to 521/,mol/L {mean 271) before stent placement, and from 8 to 1 I0/,mol/L (mean 67) at time of hospital discharge. In 5 patients 16%) the bitirubin level did not decrease due to liver failure or liver metastases.
Tectmical Percutaneous insertions of the drainage catheters and placement of the self-expandable endoprostheses were successful in all patients. In London, the stent could not be released completely in 6 patients and had to be removed by withdrawing the introducing catheter through a 9F sheath which prevented damage to the biliary tree. Following removal of the half-open stent, another endoprosthesis was inserted. This technical problem was not encountered in Switzerland. Changes in the design and technical composition of the plastic rolling membrane eliminated these problems in subsequent patients in England.
Complications In the series of 80 consecutive patients, we observed 10% minor complications in the form of one subcapsular liver hematoma (no further treatment), one subcutaneous bleeding (stopped after insertion of an 8.3F catheter), one hydroptic gallbladder due to obstruction of the cystic duct (relieved by itself), one malposition of the first stent (prompting the insertion of a second stent), one endoprosthesis release far into the duodenum (no ill-effects), one cephalad displacement of an endoprosthesis by a partially deflated angioplasty balloon (a second stent overlapping the first ensured adequate biliary drainage), and one case of blood entering the biliary tree following puncture of a subcutaneous blood vessel (no further treatment). One patient had a small subcutaneous abscess at the catheter entry site.
E.K. Salomonowltz et at." Malignant Biliary Obstruction
353
C
Fig. 2. A 67-year-old patient with pancreatic carcinoma. A ERCP s h o w s subtotal occlusion of the c o m m o n bile duct with massive proximal dilatation or" the bde ducts. B Stent ts mounted on the introducing catheter being placed through the endoscope into the c o m m o n bite duct. Lead markers delineate proximal and distal end of constrained stent ~arrows). C Released but not yet fully expanded stent. D Balloon dilatation for better stent expansion. E The stent is now well expanded. Most of the contrast material has s p o n t a n e o u s l y drained from the bile ducts. There is air m the bile ducts b e c a u s e the distat end o f the stent was placed just at the papilla.
14 patients (17.5%) due to progressive tumor growth after 3-10 months, In 5 of these patients, recurrent jaundice was seemingly due to tumor overgrowth at the proximal mouth of the stent, prompting percutaneous reentry for balloon dilatation of the tumor and/or placement of a second stent. One patient had endoscopic placement of a plastic stent.
Patient Survival
Serious complications included 7 cases of septicemia secondary to cholangitis (treated with antibiotics), 1 cholecystitis (antibiotics), I intrahepatic hematoma (no treatment), 1 bhort-term (1 day) biliovenous fistula, and 1 leakage of bile via the transhepatic tract through the cutaneous puncture for a few days following stent introduction. There were no cases of prolonged hemobilia due to damage of hepatic blood vessels. One cholecystitis occurred with hydrops of the gallbladder and prompted a percutaneous cholecystostomy at 10 days and surgical cholecystectomy another 2 weeks later. In this patient, the hydroptic gallbladder enlargement was possibly related to the stent occluding the cystic duct. This was the only complication necessitating an operative corrective action. The rate of serious complications was 15% (12 cases).
Stent Patency There were no cases of stent migration or occlusion due to bile sludge. Recurrent jaundice occurred in
There was no procedure-related mortality. The 30day mortality rate was 6.25% (5 patients). Fifty-three patients (66%) died between 3 days and t.5 years (mean 133 days after stenting); 27 patients (34%) are still alive after 2-12 months (mean 242 days): 18 of the patients who are still alive (66%) are free of jaundice.
Autopsies Fifteen patients were autopsied. In 3, tumor tissue had grown through the wire mesh after 4-6 months without causing obstruction. In 2 patients, the tumor had grown over the proximal end of the stent without intruding into the stent. When the tumor had grown to the surface of the stented bile duct, debris of necrotic ceils was found at the surface and in the lumen. However, we did not see stent occlusion by tumor bulk ingrowth into the stent. Endoprostheses of patients surviving more than 6 months were found to be covered by fibrous tissue with a mucous coat. In 2 patients who died after more than 1 year, a complete coverage by mucosa was found.
354
E.K. Salomonowltz et al.: Mahgnant Blhary Obstruction Discussion
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9
,
~.~
B
Fig, 3, A 60-year-old female patient with obstructive jaundice from cholanglocarcinoma (Ktatzkin tumor). A Percutaneous transpapfltary internal/external drainage shows tight s~enosls at the bifurcation involving two major right hepatic ducts. No opaclfication of the left hepatic duct could be seen. B A 10-ram stent was placed on the right side and a safety drain was left for 1 day. Percutaneous cholangiogram demonstrates a stenotic inflow of a cranial right hepatic duct into the stented common hepatic duct, whereas the left duct again is not opacified. C Although bilirubin levels fell, pruritus persisted becau.~e the left hepatic duct was also drained. The figure shows balloon dilatation of the hepatic bifurcation over a guidewire advanced through the first stent into the duodenum. D A second 6-ram stent was placed from the left with good drainage through both stents. E The patient survived with normal bilirubin levels for 4 months Autopsy specimen shows the left-sided stent Iwhite arrows) passing through the dilated mesh into the right-sided stent (black arrows). Both stents are widely patent (cut open).
Biliary endoprostheses of the self-expanding wire mesh design offer specific advantages when compared with plastic stents [4, 8, 10]. Specifically, the small size for introduction of the Wallstent (F-7) allows the deployment of the endoprosthesis via a relatively small tract through the liver. The endoprosthesis expands to a large lumen of6-10 mm and dislocation is very unlikely. The wire mesh allows stenting of multiple ducts. The stents may be placed parallel to each other or in a tandem fashion. We have even placed one stent through another by puncturing and dilating the mesh without ill effects. Within several months, mucosa will cover the inner surface of the stent with a natural lining. Colonization of the stent by bacteria may pose specific problems [1 I, 12]. In our patients, however, this seemingly was of no importance. Adequate bile flow minimizes the danger of local cholangitis. We have not registered patient discomfort, once the stent is in place. The complication rate is relatively low. Even if occlusion by tumor ingrowth or by bile encrustation occurs, a second balloon dilatation may be performed and even a second stent placed through the first. We have no definite answer as to what degree mucosal hyperplasia may occlude stents that are placed through malignant lesions. Although stent designs with fewer metal struts and less traumatic outward radial force may cause less mucosal reaction, a tighter mesh design hinders tumor ingrowth and a greater outward radial force may cause local tumor necrosis and thus prolong lumen patency. Experimental work presently concentrates on coated stents which might even incorporate local antitumor substances [13]. In our experience, aggressive stenting is indicated in malignant disease. To prevent tumor overgrowth we place multiple stents or stent multiple ducts. Endoscopic stents have advantages for distal common bile-duct lesions. With endoscopy, less pain and, possibly, fewer complications are to be anticipated and we employ this technique whenever possible. The Walfstent has some disadvantages~ First, the foreshortening of the stent depending on the degree of expansion; this may be important for stents to be released exactly at the papilla. The delicate stent is barely visible during deployment and high resolution fluoroscopic equipment should be used. Second, once the stent is in place, it is not exchangeable. Third, the metal endoprosthesis is expensive, especially when compared with conventional plastic biliary endoprostheses, which, when occluded, may be replaced by the endoscopist [3, 8]. Transpapillary placement of some of our stents did not cause any
E.K. Salomonow~tz et al . Mahgnant Bfliary Ob~tructlon
ill effects. Specifically, we could not demonstrate a rise of pancreatic enzymes, and no clinical pancreatitis occurred. One symptomatic superficial ulceration of the duodenal wall could be demonstrated at autopsy. One serious complication in the form of cholecystitis followed by hydrops of the gallbladder could have been caused by compression of the distal cystic duct by the relatively large caliber of the endoprosthesis and its outward radial force. The valve of Heister has a spiral form to keep the cystic duct open, and cystic duct occlusions usually occur by impacted stones or local inflammatory or desmoplastic reaction (R. Greening, personal communication). In our patient, the cholecystitis occurred within 48 h after stent placement, and the development of inflammatory reaction is very unlikely. Thus, we assume that by an error during stent placement, the proximal end of the stent with its spiculated struts had tacked down the cystic duct lumen. In conclusion, large bore self-expandable stainless steel biliary endoprostheses seem to provide a better long-term patency when compared with conventional stents and cause less discomfort for the patient. The small caliber of the constrained stent allows an easy passage through the liver and decreases the rate of possible complications. With increasing experience, one-step transhepatic procedures will become more frequent resulting in a shorter patient hospital stay and lower costs. AU, no~,'ledgmet~t. This work wab supported by the LudwlgBoltzmann-lnstitute Vienna.
for
Radlotoglcal
Tumor
Diagno>is,
355 References
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