Tsuyoshi Hamada1,2, Hiroyuki Isayama1,3, Yousuke Nakai1, Takuji Iwashita4, Yukiko Ito5, Tsuyoshi Mukai6, Hiroshi Yagioka7, Tomotaka Saito1,8, Osamu Togawa9, Shomei Ryozawa10, Kenji Hirano11, Suguru Mizuno1,12, Natsuyo Yamamoto12, Hirofumi Kogure1, Ichiro Yasuda13, Kazuhiko Koike1. 1. Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo. 2. Department of Oncologic Pathology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, USA. 3. Department of Gastroenterology, Graduate School of Medicine, Juntendo University. 4. First Department of Internal Medicine, Gifu University Hospital. 5. Department of Gastroenterology, Japanese Red Cross Medical Center. 6. Department of Gastroenterology, Gifu Municipal Hospital, Gifu. 7. Department of Gastroenterology, Tokyo Metropolitan Police Hospital. 8. Department of Gastroenterology, JR Tokyo General Hospital. 9. Department of Gastroenterology, Kanto Central Hospital. 10. Department of Gastroenterology, Saitama Medical University International Medical Center, Saitama. 11. Department of Gastroenterology, JCHO Tokyo Takanawa Hospital. 12. Department of Gastroenterology, Toshiba General Hospital, Tokyo. 13. Department of Gastroenterology, Teikyo University Mizonokuchi Hospital, Kanagawa, Japan.
Abstract
BACKGROUND AND AIM: An antireflux metal stent (ARMS) for nonresectable distal malignant biliary obstruction (MBO) may prevent recurrent biliary obstruction (RBO) as a result of duodenobiliary reflux and prolong time to RBO (TRBO). Superiority of ARMS over conventional covered self-expandable metal stents (SEMS) has not been fully examined. METHODS: We conducted a multicenter randomized controlled trial to examine whether TRBO of an ARMS with a funnel-shaped valve was longer than that of a covered SEMS in SEMS-naïve patients. We enrolled 104 patients (52 patients per arm) at 11 hospitals in Japan. Secondary outcomes included causes of RBO, adverse events, and patient survival. RESULTS:TRBO did not differ significantly between the ARMS and covered SEMS groups (median, 251 vs 351 days, respectively; P = 0.11). RBO as a result of biliary sludge or food impaction was observed in 13% and 9.8% of patients who received an ARMS and covered SEMS, respectively (P = 0.83). ARMS was associated with a higher rate of stent migration compared with the covered SEMS (31% vs 12%, P = 0.038). Overall rates of adverse events were 20% and 18% in the ARMS and covered SEMS groups, respectively (P = 0.97). No significant between-group difference in patient survival was observed (P = 0.26). CONCLUSIONS: The current ARMS was not associated with longer TRBO compared with the covered SEMS. Modifications including addition of an anti-migration system are required to use the current ARMS as first-line palliative treatment of distal MBO (UMIN-CTR clinical trial registration number: UMIN000014784).
RCT Entities:
BACKGROUND AND AIM: An antireflux metal stent (ARMS) for nonresectable distal malignant biliary obstruction (MBO) may prevent recurrent biliary obstruction (RBO) as a result of duodenobiliary reflux and prolong time to RBO (TRBO). Superiority of ARMS over conventional covered self-expandable metal stents (SEMS) has not been fully examined. METHODS: We conducted a multicenter randomized controlled trial to examine whether TRBO of an ARMS with a funnel-shaped valve was longer than that of a covered SEMS in SEMS-naïve patients. We enrolled 104 patients (52 patients per arm) at 11 hospitals in Japan. Secondary outcomes included causes of RBO, adverse events, and patient survival. RESULTS: TRBO did not differ significantly between the ARMS and covered SEMS groups (median, 251 vs 351 days, respectively; P = 0.11). RBO as a result of biliary sludge or food impaction was observed in 13% and 9.8% of patients who received an ARMS and covered SEMS, respectively (P = 0.83). ARMS was associated with a higher rate of stent migration compared with the covered SEMS (31% vs 12%, P = 0.038). Overall rates of adverse events were 20% and 18% in the ARMS and covered SEMS groups, respectively (P = 0.97). No significant between-group difference in patient survival was observed (P = 0.26). CONCLUSIONS: The current ARMS was not associated with longer TRBO compared with the covered SEMS. Modifications including addition of an anti-migration system are required to use the current ARMS as first-line palliative treatment of distal MBO (UMIN-CTR clinical trial registration number: UMIN000014784).
Authors: Sang Hoon Kim; Chi Hyuk Oh; Jae Min Lee; Seong Ji Choi; Hyuk Soon Choi; Eun Sun Kim; Bora Keum; Yoon Tae Jeen; Hoon Jai Chun; Hong Sik Lee; Chang Duck Kim Journal: Medicine (Baltimore) Date: 2020-04 Impact factor: 1.817