A Prospective Multicenter Study of "Inside Stents" for Biliary Stricture: Multicenter Evolving Inside Stent Registry (MEISteR).

Hirofumi Kogure,Yousuke Nakai,Tesshin Ban,Akio Katanuma,Kazuya Sugimori,Keiji Hanada,Yoshinobu Okabe,Toru Ueki,Hirotoshi Ishiwatari,Kazumichi Kawakubo,Hiroyuki Isayama,Hironari Kato

doi:10.3390/jcm10132936

Abstract

Background: Endoscopic biliary stent placement is the standard of care for biliary strictures, but stents across the papilla are prone to duodenobiliary reflux, which can cause stent occlusion. Preliminary studies of “inside stents” placed above the papilla showed encouraging outcomes, but prospective data with a large cohort were not reported. Methods: This was a prospective multicenter registry of commercially available inside stents for benign and malignant biliary strictures. Primary endpoint was recurrent biliary obstruction (RBO). Secondary endpoints were technical success of stent placement and removal, adverse events, and stricture resolution. Results: A total of 209 inside stents were placed in 132 (51 benign and 81 malignant) cases with biliary strictures in 10 Japanese centers. During the follow-up period of 8.4 months, RBO was observed in 19% of benign strictures. The RBO rate was 49% in malignant strictures, with the median time to RBO of 4.7 months. Technical success rates of stent placement and removal were both 100%. The adverse event rate was 8%. Conclusion: This prospective multicenter study demonstrated that inside stents above the papilla were feasible in malignant and benign biliary strictures, but a randomized controlled trial is warranted to confirm its superiority to conventional stents across the papilla.

Highlights

Endoscopic biliary stent placement is the standard of care for both malignant and benign biliary strictures
The prior biliary drainage was inside stents in 31, endoscopic nasobiliary drainage (ENBD) tube in 30 patients, conventional plastic stents across the papilla in 7 patients, and percutaneous transhepatic biliary drainage in 1 patient
While planned stent exchange was performed in 80% of benign strictures, on-demand exchange at the time of stent occlusion was selected in 54% of malignant biliary strictures

Summary

Introduction

Endoscopic biliary stent placement is the standard of care for both malignant and benign biliary strictures. Inside stents with a retrieval thread are commercially available in Japan [21], and we conducted this prospective multicenter cohort study to evaluate the safety and effectiveness of these commercially available inside stents in patients with both malignant and benign biliary strictures. Endoscopic biliary stent placement is the standard of care for biliary strictures, but stents across the papilla are prone to duodenobiliary reflux, which can cause stent occlusion. Conclusion: This prospective multicenter study demonstrated that inside stents above the papilla were feasible in malignant and benign biliary strictures, but a randomized controlled trial is warranted to confirm its superiority to conventional stents across the papilla

Methods

Results

Conclusion