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)

Background: Fully-covered self expandable metal stents (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 stent 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 stent 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 stent 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 migration (1, stent replaced) or stent clogging (2, managed endoscopically) and worsening of CP (2). In these patients, the fcSEMS was removed and replaced after pancreatic sphincterotomy and PD stent placement. Median follow-up was 15 months (range 11-25). Overall treatment success was 61% (14/23); in the CP group 46%, in the remaining patients 80% (p = 0.11). Patients with stricture resolution after removal of the first stent (n = 7; success 6/7) showed a trent towards a more sustained treatment success than patients who needed a 2nd stent placement (n = 16; success 8/16); p = 0.12). 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.

• View at Publisher
• View at Pubmed
• View at Scopus
• View at Web of Science