Su1430 Stent Removability and Mid-Term Stricture Resolution After Multi-Month Metal Stenting of Benign Biliary Strictures: Interim Report From an International Prospective Trial in 187 Patients

Stent Removability and Mid-Term Stricture Resolution After Multi-Month Metal Stenting of Benign Biliary Strictures: Interim Report From an International Prospective Trial in 187 Patients Guido Costamagna*, D. Nageshwar Reddy, Andreas Puspok, Thierry Ponchon, Marco J. Bruno, Michael J. Bourke, Horst Neuhaus, Andre Roy, FerraN GonzaLez-Huix, Alan N. Barkun, Paul P. Kortan, Claudio Navarrete, Jacques M. Deviere Digestive Endoscpy Unit Universita Cattolica del Sacro Cuore, Rome, Italy; Asian Institute of Gastroenterology, Hyderabad, India; Medical University of Vienna, Vienna, Austria; Hopital Edouard Herriot, Lyon, France; Erasmus Medical Center, Rotterdam, Netherlands; Westmead Hospital, Westmead, NSW, Australia; EVK Krankenhaus Dusseldorf, Dusseldorf, Germany; Montreal-Saint-Luc Hospital, Montreal, QC, Canada; Hospital Universitari Doctor Josep Trueta, Girona, Spain; McGill University Hospital, Montreal, QC, Canada; St. Michael’s Hospital, Toronto, ON, Canada; Clinica Alemana de Santiago, Santiago, Chile; Erasme Hospital, Brussels, Belgium Background and Aims: Use of fully-covered self-expanding metal stents (FCSEMS) for treatment of benign biliary strictures is becoming more broadly adopted but long term prospective effectiveness data are needed. Methods: FCSEMS (WallFlex Biliary RX Fully Covered Stent, Boston Scientific, Natick, MA) were placed in 187 patients (pts) with benign biliary strictures associated with chronic pancreatitis (CP, 127), liver transplantation (OLT, 42), and post-operative complications (PO, 18). Strictures could be naive or previously dilated using plastic stents. Per protocol (PP) FCSEMS indwell was 11 months in CP and PO pts and 5 months in OLT pts, with a planned 5 year post removal follow-up (f/ u). Endpoints include stent removability (primary) defined as ability to remove FCSEMS endoscopically without stent-removal-related adverse event (AE), stricture resolution and AEs. This report includes removability results for all pts and stricture resolution for subset of pts with at least 1 year of f/u based on enrollment dates. Results and Discussion: Mean age 54 years, 145/187 (78%) male. At least 1 prior plastic stent in 139 (74%) pts. Removability could be assessed in 171 (91%) pts as 16 pts were discontinued early due to unrelated death or progression to cancer (9) or to loss to f/u (7). All 171 stents were removed endoscopically (154) or passed spontaneously (17). Five endoscopic removals required a stent-in-stent technique. Removability was confirmed in 164 (96%) pts. There were 7 stent-removal-related AEs: cholangitis (4), pancreatitis (1), self-limiting bleed (1) and RUQ pain (1). To-date, of the 171 pts, 95 have at least 1 year f/u (53 CP, 33 OLT and 9 PO). PP stent removal took place in 72 (76%) pts (44 CP, 22 OLT, 6 PO). Early stent removal (15) or complete distal migration (8) occurred in 23 (24%) pts (9 CP, 11 OLT, 3 PO) with stricture resolution in 6 pts and immediate restenting in 17 pts. In total stent-related AEs were cholangitis (14), cholestasis (5), RUQ pain (3), pancreatitis (3), biliary leaks (1) with no stent-related deaths. After PP FCSEMS removal with mean f/u to date of 569 days ( 103), there was overall stricture resolution in 55 (76%) pts, namely in 35 (80%) CP pts, 15 (68%) OLT pts and 5 (83%) PO pts. F/u is ongoing. Updated results will be presented. Conclusion: Endoscopic FCSEMS removal after up to a year of indwell in benign biliary strictures was possible with acceptable complication profile. Preliminary stricture resolution rates with mean f/u of 18 months appears promising, particularly in CP related and PO biliary strictures. Longer follow-up is required.