Fully covered self-expandable metallic stents in the management of complex biliary leaks: preliminary data – a case series[1]

Introduction

Biliary leaks typically occur following traumatic injury [1] [2] or surgical intervention, such as cholecystectomy, partial hepatic resection, and liver transplantation. A clinically significant postoperative bile leak occurs in 0.1 % – 0.5 % of open cholecystectomies [3], 0.8 % – 2 % of laparoscopic cholecystectomies [3] [4] [5] [6], about 12 % of cadaveric liver transplantations [7], and 6 % – 14 % of hepatic resections [8].

The role of endoscopic therapy in the treatment of bile leaks is well established. Therapeutic endoscopic retrograde cholangiography (ERC) with biliary sphincterotomy [3] [9], placement of a transpapillary biliary stent [1] [3] [8] [9], or combination biliary sphincterotomy and stenting [3] [9] has become the first-line intervention in the treatment of a bile leak. For high-grade bile leaks, sphincterotomy alone has been shown to be less effective than transpapillary biliary stenting [3], and combined biliary sphincterotomy and transpapillary stenting is preferable in such situations [3] [10]. ERC has been shown to be effective in resolving 70 % – 100 % of postcholecystectomy bile leaks [3] and up to 84 % of bile leaks after cadaveric liver transplant [11]. Large or complex bile leaks require the placement of multiple large stents that span the bile leak and the sphincter of Oddi, but surgery is sometimes still required [3] [11] [12] [13].

Previously, we have described the use of partially covered self-expandable metallic stents (PCMS) in the treatment of complex bile leaks [14] and benign biliary strictures [15]. Although PCMS were effective in resolving bile leaks and benign strictures, they were prone to migration and mucosal hyperplasia at the uncovered ends [14] [15].

Recently, a fully covered self-expandable metallic stent (CSEMS) has become available for endoscopic deployment. This CSEMS has anchoring fins positioned at opposite ends of the stent to reduce stent migration [16] [17].

The aim of this study was to investigate the safety and efficacy of endoscopic temporary placement of a biliary CSEMS in the treatment of complex bile leaks.

1 This work was presented in part at the annual meeting of the American Society of Gastrointestinal Endoscopy, Digestive Diseases Week, May 17 to 22, 2008, San Diego, Calif., USA. Abstract was published in Gastrointest Endosc 2008; 67: AB162.

References

• 1 Bridges A, Wilcox C M, Varadarajulu S. Endoscopic management of traumatic bile leaks.  Gastrointestinal endoscopy. 2007;  65 1081-1085
• 2 Lubezky N, Konikoff F M, Rosin D. et al . Endoscopic sphincterotomy and temporary internal stenting for bile leaks following complex hepatic trauma.  Br J Surg. 2006;  93 78-81
• 3 Sandha G S, Bourke M J, Haber G B, Kortan P P. Endoscopic therapy for bile leak based on a new classification: results in 207 patients.  Gastrointest Endosc. 2004;  60 567-574
• 4 Barkun A N, Rezieg M, Mehta S N. et al . Postcholecystectomy biliary leaks in the laparoscopic era: risk factors, presentation, and management. McGill Gallstone Treatment Group.  Gastrointest Endosc. 1997;  45 277-282
• 5 Trondsen E, Ruud T E, Nilsen B H. et al . Complications during the introduction of laparoscopic cholecystectomy in Norway. A prospective multicentre study in seven hospitals.  Eur J Surg. 1994;  160 145-151
• 6 Albasini J L, Aledo V S, Dexter S P. et al . Bile leakage following laparoscopic cholecystectomy.  Surg Endosc. 1995;  9 1274-1278
• 7 Shah J N, Ahmad N A, Shetty K. et al . Endoscopic management of biliary complications after adult living donor liver transplantation.  Am J Gastroenterol. 2004;  99 1291-1295
• 8 Bhattacharjya S, Puleston J, Davidson B R, Dooley J S. Outcome of early endoscopic biliary drainage in the management of bile leaks after hepatic resection.  Gastrointest Endosc. 2003;  57 526-530
• 9 Kaffes A J, Hourigan L, De uca N. et al . Impact of endoscopic intervention in 100 patients with suspected postcholecystectomy bile leak.  Gastrointest Endosc. 2005;  61 269-275
• 10 Simmons D T, Petersen B T, Gostout C J. et al . Risk of pancreatitis following endoscopically placed large-bore plastic biliary stents with and without biliary sphincterotomy for management of postoperative bile leaks.  Surg Endosc. 2008;  22 1459-1463
• 11 Pfau P R, Kochman M L, Lewis J D. et al . Endoscopic management of postoperative biliary complications in orthotopic liver transplantation.  Gastrointest Endosc. 2000;  52 55-63
• 12 Lillemoe K D, Melton G B, Cameron J L. et al . Postoperative bile duct strictures: management and outcome in the 1990 s.  Ann Surg. 2000;  232 430-441
• 13 Katsinelos P, Kountouras J, Paroutoglou G. et al . A comparative study of 10-Fr vs. 7-Fr straight plastic stents in the treatment of postcholecystectomy bile leak.  Surg Endosc. 2008;  22 101-106
• 14 Kahaleh M, Sundaram V, Condron S L. et al . Temporary placement of covered self-expandable metallic stents in patients with biliary leak: midterm evaluation of a pilot study.  Gastrointest Endosc. 2007;  66 52-59
• 15 Kahaleh M, Behm B, Clarke B W. et al . Temporary placement of covered self-expandable metal stents in benign biliary strictures: a new paradigm? (with video).  Gastrointest Endosc. 2008;  67 446-454
• 16 Bezzi M, Zolovkins A, Cantisani V. et al . New ePTFE/FEP-covered stent in the palliative treatment of malignant biliary obstruction.  J Vasc Interv Radiol. 2002;  13 581-589
• 17 Kuo M D, Lopresti D C, Gover D D. et al . Intentional retrieval of viabil stent-grafts from the biliary system.  J Vasc Interv Radiol. 2006;  17 389-397
• 18 Leung J W, Del avero G, Cotton P B. Endoscopic biliary prostheses: a comparison of materials.  Gastrointestinal endoscopy. 1985;  31 93-95
• 19 Soderlund C, Linder S. Covered metal versus plastic stents for malignant common bile duct stenosis: a prospective, randomized, controlled trial.  Gastrointest Endosc. 2006;  63 986-995
• 20 Davids P H, Groen A K, Rauws E A. et al . Randomised trial of self-expanding metal stents versus polyethylene stents for distal malignant biliary obstruction.  Lancet. 1992;  340 1488-1492
• 21 Knyrim K, Wagner H J, Pausch J, Vakil N. A prospective, randomized, controlled trial of metal stents for malignant obstruction of the common bile duct.  Endoscopy. 1993;  25 207-212
• 22 Prat F, Chapat O, Ducot B. et al . A randomized trial of endoscopic drainage methods for inoperable malignant strictures of the common bile duct.  Gastrointest Endosc. 1998;  47 1-7
• 23 Kaassis M, Boyer J, Dumas R. et al . Plastic or metal stents for malignant stricture of the common bile duct? Results of a randomized prospective study.  Gastrointest Endosc. 2003;  57 178-182
• 24 Condron S, Wang A, Morris T, Yeaton P. Pathological analysis of covered self-expanding metallic stents after pancreaticobiliary extraction.  Gastrointest Endosc. 2008;  67 AB233

1 This work was presented in part at the annual meeting of the American Society of Gastrointestinal Endoscopy, Digestive Diseases Week, May 17 to 22, 2008, San Diego, Calif., USA. Abstract was published in Gastrointest Endosc 2008; 67: AB162.