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)

Jan-werner Poley, Djuna Cahen, Herold Metselaar, Henk van Buuren, G Kazemier, Casper van Eijck, J Haringsma, Ernst Kuipers, Marco Bruno

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Background: Fully-covered self expandable metal stems (fcSEMSs) are an alternative to progressive plastic stenting for the treatment of benign biliary strictures (BBS) with the prospect of a higher treatment efficacy and the need for fewer ERCPs, thereby reducing the burden for patients and possibly costs. Key to this novel treatment is safe stent removal. Objective: To investigate the feasibility and safety of stem removal of a fcSEMS with a proximal retrieval lasso: a long wire thread integrated in the proximal ends of the wire mesh that hangs freely in the stem lumen. Pulling it enables gradual removal of the stent inside-out. A secondary aim was success of stricture resolution. Design: Non-randomized, prospective follow-up study with 3 sequential cohorts of 8 patients with BBS. Setting: Academic tertiary referral center. Patients: Eligible patients had strictures either postsurgical (post-cholecystectomy (LCx) or liver transplantation (OLT)), due to chronic pancreatitis (CP), or papillary stenosis (PF). Strictures had to be located at least 2 cm below the liver hilum. All patients had one plastic stent in situ across the stricture and had not undergone previous treatment with either multiple plastic stents or fcSEMS. Interventions: The first cohort of patients underwent stent placement for 2 months, followed by 3 months if the stricture had not resolved. The second and third cohort started with 3 months and 4 months, respectively, both followed by another 4 months if indicated. Treatment success was defined by stricture resolution at cholangiography, the ability to pass an inflated extraction balloon and clinical follow-up (at least 6 months). Main outcome measurement: safety of stem removal. Secondary outcomes were complications and successful stricture resolution. Results: A total of 23 patients (11 female; 20-67 yrs) were eligible for final analysis. One Patient developed a malignant neuroendocrine tumor in the setting of CP. Strictures were caused by CP (13), OLT (6), LCx (3) and PF (1). In total 39 fcSEMS were placed and removed. Removals were easy and without complications. Transient pain after insertion was common (13 of 23/56%) but was easily managed by analgesics in all patients. Other complications were cholecystitis (1), cholangitis due to stent Limitations: Small number of patients with regard to secondary outcomes. Conclusion: Removal of a new type of fcSEMS with a proximal retrieval lasso in patients with BBS proved easy and uncomplicated. Treatment success for CP strictures was higher compared to what is known from results of progressive plastic stenting protocols. For other indications treatment success was comparable to progressive plastic stenting, but with the prospect of fewer ERCP procedures. (Gastrointest Endosc 2012;75:783-9.)
Original languageUndefined/Unknown
Pages (from-to)783-789
Number of pages7
JournalGastrointestinal Endoscopy
Issue number4
Publication statusPublished - 2012

Research programs

  • EMC MM-03-47-11
  • EMC MM-04-20-01
  • EMC MM-04-20-02-A

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