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Antireflux metal stent vs. conventional covered metal stent for nonresectable distal malignant biliary obstruction: a multicenter randomized controlled trial
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Tsuyoshi Hamada1,
Hiroyuki Isayama1,2,
Kazuhiko Koike1 |
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1Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, 2Department of Gastroenterology, Graduate School of Medicine, Juntendo University |
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| Background: An antireflux metal stent (ARMS) for nonresectable distal malignant biliary obstruction may prevent recurrent biliary obstruction (RBO) caused by the duodenobiliary reflux and thereby provide long time to RBO (TRBO). The superiority of the ARMS over conventional covered self-expandable metal stents (SEMSs) has not 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 patients without a history of SEMS placement. Secondary outcomes included causes of RBO, adverse events, and patient survival. Results: We enrolled 104 patients (52 patients per arm) from September 2014 to June 2016 at 11 tertiary care centers in Japan. The median TRBO did not differ significantly between the ARMS and covered SEMS groups (251 and 351 days, respectively; P = 0.11). RBO due to biliary sludge or food impaction was observed in 13% and 9.8% patients who received an ARMS and covered SEMS, respectively (P = 0.083). The ARMS appeared to be associated with a higher rate of stent migration compared with the covered SEMS (31% vs. 12%, respectively; P = 0.038). No significant between-group difference was observed for adverse events or patient survival. Conclusions: The current ARMS was not associated with longer TRBO compared with the covered SEMS. Further modifications including addition of an anti-migration system are required to justify the use of the current ARMS as a first-line palliative treatment modality for distal malignant biliary obstruction. |
Index Term 1: self-expandable metal stent
Index Term 2: biliary stricture |
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