Hirofumi Kogure1, Hironari Kato2, Kazumichi Kawakubo3, Hirotoshi Ishiwatari4, Akio Katanuma5, Yoshinobu Okabe6, Toru Ueki7, Tesshin Ban8, Keiji Hanada9, Kazuya Sugimori10, Yousuke Nakai1,11, Hiroyuki Isayama1,12. 1. Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo 113-8655, Japan. 2. Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama 700-8558, Japan. 3. Department of Gastroenterology and Hepatology, Hokkaido University Graduate School of Medicine, Sapporo 060-8648, Japan. 4. Department of Medical Oncology and Hematology, Sapporo Medical University School of Medicine, Sapporo 060-8543, Japan. 5. Center for Gastroenterology, Teine-Keijinkai Hospital, Sapporo 006-0811, Japan. 6. Division of Gastroenterology, Department of Medicine, Kurume University of Medicine, Kurume 830-0011, Japan. 7. Department of Internal Medicine, Fukuyama City Hospital, Fukuyama 721-8511, Japan. 8. Department of Gastroenterology, Nagoya Daini Red Cross Hospital, Nagoya 466-8650, Japan. 9. Department of Gastroenterology, Onomichi General Hospital, Onomichi 722-8508, Japan. 10. Division of Gastroenterology, Yokohama City University Graduate School of Medicine, Yokohama 232-0024, Japan. 11. Department of Endoscopy and Endoscopic Surgery, Graduate School of Medicine, The University of Tokyo, Tokyo 113-8655, Japan. 12. Department of Gastroenterology, Graduate School of Medicine, Juntendo University, Tokyo 113-8431, Japan.
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.
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.