Randomized multicenter study of multiple plastic stents vs. covered self-expandable metallic stent in the treatment of biliary stricture in chronic pancreatitis

Background and study aims: The use of covered self-expandable metallic stents (cSEMS) in benign biliary indications is evolving. The aim of the study was to assess the safety and feasibility of cSEMS compared with multiple plastic stents in the treatment of benign biliary stricture (BBS) caused by chronic pancreatitis.

Patients and methods: This was a prospective, multicenter, randomized study of 60 patients with BBS caused by chronic pancreatitis. All patients received an initial plastic stent before randomization. At randomization, the stent was replaced either with a single cSEMS or three plastic stents. After 3 months, the position of the cSEMS was checked or another three plastic stents were added. At 6 months after randomization, all stents were removed. Clinical follow-up including abdominal ultrasound and laboratory tests were performed at 6 months and 2 years after stent removal.

Results: Two patients dropped out of the cSEMS group before stent removal. In April 2014, the median follow-up was 40 months (range 1 – 66 months). The 2-year, stricture-free success rate was 90 % (95 % confidence interval [CI] 72 % – 97 %) in the plastic stent group and 92 % (95 %CI 70 % – 98 %) in the cSEMS group (P = 0.405). There was one late recurrence in the plastic stent group 50 months after stent removal. Stent migration occurred three times (10 %) in the plastic stent group and twice in the cSEMS group (7 %; P = 1.000).

Conclusion: A 6-month treatment with either six 10-Fr plastic stents or with one 10-mm cSEMS produced good long-term relief of biliary stricture caused by chronic pancreatitis.

Study registered at ClinicalTrials.gov (NCT01085747).

• References

• 1 Abdallah AA, Krige JE, Bornman PC. Biliary tract obstruction in chronic pancreatitis. HPB (Oxford) 2007; 9: 421-428
• 2 Warshaw AL, Schapiro RH, Ferruci JJ. Persistent obstructive jaundice, cholangitis, and biliary cirrhosis due to common bile duct stenosis in chronic pancreatitis. Gastroenterology 1976; 70: 562-567
• 3 Dumonceau JM, Delhaye M, Tringali A et al. Endoscopic treatment of chronic pancreatitis: European Society of Gastrointestinal Endoscopy (ESGE) clinical guideline. Endoscopy 2012; 44: 784-800
• 4 Kahl S, Zimmermann S, Glasbrenner B et al. Treatment of benign biliary strictures in chronic pancreatitis by self-expandable metal stents. Dig Dis 2002; 20: 199-203
• 5 Pozsar J, Sahin P, Laszlo F et al. Medium-term results of endoscopic treatment of common bile duct strictures in chronic calcifying pancreatitis with increasing numbers of stents. J Clin Gastroenterol 2004; 38: 118-123
• 6 Catalano MF, Linder JD, George S et al. Treatment of symptomatic distal common bile duct stenosis secondary to chronic pancreatitis: comparison of single vs. multiple simultaneous stents. Gastrointest Endosc 2004; 60: 945-952
• 7 Siriwardana HP, Siriwardena AK. Systematic appraisal of the role of metallic endobiliary stents in the treatment of benign bile duct stricture. Ann Surg 2005; 242: 10-19
• 8 van Boeckel PG, Vleggaar FP, Siersema PD. Plastic or metal stents for benign extrahepatic biliary strictures: a systematic review. BMC Gastroenterol 2009; 9: 96
• 9 Judah JR, Draganov PV. Endoscopic therapy of benign biliary strictures. World J Gastroenterol 2007; 13: 3531-3539
• 10 Kahaleh M, Behm B, Clarke BW 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
• 11 Behm B, Brock A, Clarke BW et al. Partially covered self-expandable metallic stents for benign biliary strictures due to chronic pancreatitis. Endoscopy 2009; 41: 547-551
• 12 Ryu CH, Kim MH, Lee SS et al. Temporary placement of fully covered self-expandable metal stents in benign biliary strictures. Korean J Gastroenterol 2013; 62: 49-54
• 13 Irani S, Baron TH, Akbar A et al. Endoscopic treatment of benign biliary strictures using covered self-expandable metal stents (CSEMS). Dig Dis Sci 2014; 59: 152-160
• 14 Haapamaki C, Udd M, Halttunen J et al. Endoscopic treatment of anastomotic biliary complications after liver transplantation using removable, covered, self-expandable metallic stents. Scand J Gastroenterol 2012; 47: 116-121
• 15 Cotton PB, Lehman G, Vennes J et al. Endoscopic sphincterotomy complications and their management: an attempt at consensus. Gastrointest Endosc 1991; 37: 383-393
• 16 Draganov P, Hoffman B, Marsh W et al. Long-term outcome in patients with benign biliary strictures treated endoscopically with multiple stents. Gastrointest Endosc 2002; 55: 680-686
• 17 Costamagna G, Pandolfi M, Mutignani M et al. Long-term results of endoscopic management of postoperative bile duct strictures with increasing numbers of stents. Gastrointest Endosc 2001; 54: 162-168
• 18 Lawrence C, Romagnuolo J, Payne KM et al. Low symptomatic premature stent occlusion of multiple plastic stents for benign biliary strictures: comparing standard and prolonged stent change intervals. Gastrointest Endosc 2010; 72: 558-563
• 19 Kassab C, Prat F, Liguory C et al. Endoscopic management of post-laparoscopic cholecystectomy biliary strictures. Long-term outcome in a multicenter study. Gastroenterol Clin Biol 2006; 30: 124-129
• 20 Kuzela L, Oltman M, Sutka J et al. Prospective follow-up of patients with bile duct strictures secondary to laparoscopic cholecystectomy, treated endoscopically with multiple stents. Hepatogastroenterology 2005; 52: 1357-1361
• 21 Weber A, Zellner S, Wagenpfeil S et al. Long-term follow-up after endoscopic stent therapy for benign biliary strictures. J Clin Gastroenterol 2014; 48: 88-93
• 22 Smith AC, Dowsett JF, Russell RC et al. Randomised trial of endoscopic stenting versus surgical bypass in malignant low bile duct obstruction. Lancet 1994; 344: 1655-1660
• 23 Andersen J, Sorensen S, Kruse A et al. Randomised trial of endoscopic endoprosthesis versus operative bypass in malignant obstructive jaundice. Gut 2003; 30: 1132-1135
• 24 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
• 25 Poley JW, Cahen DL, Metselaar HJ et al. A prospective group sequential study evaluating a new type of fully covered self-expandable metal stent for the treatment of benign biliary strictures (with video). Gastrointest Endosc 2012; 75: 783-789