Abstract
BackgroundEndoscopic treatment of post-cholecystectomy biliary strictures (PCBS) with multiple plastic biliary stents placed sequentially is a minimally invasive alternative to surgery but requires multiple interventions. Temporary placement of a single fully-covered self-expanding metal stent (FCSEMS) may offer safe and effective treatment with fewer re-interventions. Long-term effectiveness of treatment with FCSEMS to obtain PCBS resolution has not yet been studied.MethodsIn this prospective multi-national study in patients with symptomatic benign biliary strictures (N = 187) due to various etiologies received a FCSEMS with scheduled removal at 6–12 months and were followed for 5 years. We report here long-term outcomes of the subgroup of patients with PCBS (N = 18). Kaplan Meier analyses assessed long-term freedom from re-stenting. Adverse events were documented.ResultsEndoscopic removal of the FCSEMS was achieved in 83.3% (15/18) of patients after median indwell of 10.9 (range 0.9–13.8) months. In the remaining 3 patients (16.7%), the FCSEMS spontaneously migrated and passed without complications. At the end of FCSEMS indwell, 72% (13/18) of patients had stricture resolution. At 5 years after FCSEMS removal, 84.6% (95% CI 65.0–100.0%) of patients who had stricture resolution at FCSEMS removal remained stent-free. In addition, at 75 months after FCSEMS placement, the probability of remaining stent-free was 61.1% (95% CI 38.6–83.6%) for all patients. Stent or removal related serious adverse events occurred in 38.9% (7/18) all resolved without sequalae.ConclusionsIn patients with symptomatic PCBS, temporary placement of a single FCSEMS intended for 10–12 months indwell is associated with long-term stricture resolution up to 5 years. Temporary placement of a single FCSEMS may be considered for patients with PCBS not involving the main hepatic confluence.Trial registration numbersNCT01014390; CTRI/2012/12/003166; Registered 17 November 2009.
Highlights
Endoscopic treatment of post-cholecystectomy biliary strictures (PCBS) with multiple plastic biliary stents placed sequentially is a minimally invasive alternative to surgery but requires multiple interventions
Post-operative benign biliary strictures (BBS) most typically result from bile duct injury during cholecystectomy, with post-cholecystectomy biliary strictures (PCBS) occurring in 0–0.6% of laparoscopic cholecystectomy cases [3,4,5]
We previously reported the results of a prospective, non-randomized study assessing the placement of a biliary fully-covered self-expanding metal stent (FCSEMS) (WallFlex Biliary RX Stent; Boston Scientific, Natick, MA) with intended indwell for 6–12 months, in 187 patients with BBS secondary to chronic pancreatitis, or anastomotic BBS after orthotopic liver transplantation, or caused by bile duct injury during cholecystectomy (PCBS)
Summary
Endoscopic treatment of post-cholecystectomy biliary strictures (PCBS) with multiple plastic biliary stents placed sequentially is a minimally invasive alternative to surgery but requires multiple interventions. Temporary placement of a single fully-covered self-expanding metal stent (FCSEMS) may offer safe and effective treatment with fewer re-interventions. Endotherapy of BBS may include any combination of ductal dilation with biliary balloons and extended duration endoscopic stenting. The latter involves placement of multiple plastic stents (MPS) and subsequent MPS exchanges every 3 to 4 months for approximately 1 year, or temporary placement of a fully covered self-expanding metal stent (FCSEMS). These endoscopic treatment modalities are all focused on reestablishing luminal patency. PCBSs may cause chronic cholestasis and jaundice, recurrent cholangitis, and secondary biliary cirrhosis, all of which can lead to serious and even fatal outcomes
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