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)

• Published in: Gastrointestinal endoscopy 2012-04, Vol.75 (4), p.783-789
• Main Authors: Poley, Jan-Werner, MD, Cahen, Djuna L., MD, PhD, Metselaar, Herold J., MD, PhD, van Buuren, Henk R., MD, PhD, Kazemier, Geert, MD, PhD, van Eijck, Casper H.J., MD, PhD, Haringsma, Jelle, MD, Kuipers, Ernst J., MD, PhD, Bruno, Marco J., MD, PhD
• Format: Article
• Language: English
• Subjects: Adult; Aged; Biological and medical sciences; Cholecystectomy - adverse effects; Cholestasis - diagnostic imaging; Cholestasis - etiology; Cholestasis - therapy; Constriction, Pathologic - diagnostic imaging; Constriction, Pathologic - etiology; Constriction, Pathologic - therapy; Device Removal - adverse effects; Device Removal - methods; Digestive system. Abdomen; Endoscopy; Female; Follow-Up Studies; Gastroenterology and Hepatology; Gastroenterology. Liver. Pancreas. Abdomen; Humans; Investigative techniques, diagnostic techniques (general aspects); Liver Transplantation - adverse effects; Liver. Biliary tract. Portal circulation. Exocrine pancreas; Male; Medical sciences; Middle Aged; Other diseases. Semiology; Pancreatitis, Chronic - complications; Radiography; Stents - adverse effects; Time Factors; Treatment Outcome; Young Adult
• ISSN: 0016-5107; 1097-6779
• DOI: 10.1016/j.gie.2011.10.022

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 pl