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Antireflux covered metal stent for nonresectable distal malignant biliary obstruction: Multicenter randomized controlled trial
Author(s) -
Hamada Tsuyoshi,
Isayama Hiroyuki,
Nakai Yousuke,
Iwashita Takuji,
Ito Yukiko,
Mukai Tsuyoshi,
Yagioka Hiroshi,
Saito Tomotaka,
Togawa Osamu,
Ryozawa Shomei,
Hirano Kenji,
Mizuno Suguru,
Yamamoto Natsuyo,
Kogure Hirofumi,
Yasuda Ichiro,
Koike Kazuhiko
Publication year - 2019
Publication title -
digestive endoscopy
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.5
H-Index - 56
eISSN - 1443-1661
pISSN - 0915-5635
DOI - 10.1111/den.13381
Subject(s) - medicine , stent , adverse effect , randomized controlled trial , multicenter trial , surgery , multicenter study
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: UMIN 000014784).