Antireflux covered metal stent for nonresectable distal malignant biliary obstruction: Multicenter randomized controlled trial

被引：35

作者：

Hamada, Tsuyoshi ^{[1
,13
,14
]}

Isayama, Hiroyuki ^{[1
,2
]}

Nakai, Yousuke ^{[1
]}

Iwashita, Takuji ^{[9
]}

Ito, Yukiko ^{[3
]}

Mukai, Tsuyoshi ^{[10
]}

Yagioka, Hiroshi ^{[4
]}

Saito, Tomotaka ^{[1
,5
]}

Togawa, Osamu ^{[6
]}

Ryozawa, Shomei ^{[11
]}

Hirano, Kenji ^{[7
]}

Mizuno, Suguru ^{[1
,8
]}

Yamamoto, Natsuyo ^{[8
]}

Kogure, Hirofumi ^{[1
]}

Yasuda, Ichiro ^{[12
]}

Koike, Kazuhiko ^{[1
]}

机构：

[1] Univ Tokyo, Grad Sch Med, Dept Gastroenterol, Tokyo, Japan

[2] Juntendo Univ, Grad Sch Med, Dept Gastroenterol, Tokyo, Japan

[3] Japanese Red Cross Med Ctr, Dept Gastroenterol, Tokyo, Japan

[4] Tokyo Metropolitan Police Hosp, Dept Gastroenterol, Tokyo, Japan

[5] JR Tokyo Gen Hosp, Dept Gastroenterol, Tokyo, Japan

[6] Kanto Cent Hosp, Dept Gastroenterol, Tokyo, Japan

[7] JCHO Tokyo Takanawa Hosp, Dept Gastroenterol, Tokyo, Japan

[8] Toshiba Gen Hosp, Dept Gastroenterol, Tokyo, Japan

[9] Gifu Univ Hosp, Dept Internal Med 1, Gifu, Japan

[10] Gifu Municipal Hosp, Dept Gastroenterol, Gifu, Japan

[11] Saitama Med Univ, Int Med Ctr, Dept Gastroenterol, Saitama, Japan

[12] Teikyo Univ, Mizonokuchi Hosp, Dept Gastroenterol, Kawasaki, Kanagawa, Japan

[13] Dana Farber Canc Inst, Dept Oncol Pathol, Boston, MA 02115 USA

[14] Harvard Med Sch, Boston, MA 02115 USA

来源：

DIGESTIVE ENDOSCOPY | 2019年 / 31卷 / 05期

关键词：

common bile duct; endoscopic retrograde cholangiopancreatography; extrahepatic cholestasis; pancreatic neoplasm; stent; PLASTIC STENTS; PALLIATION; STRICTURES; MANAGEMENT; RISK; PLACEMENT; MIGRATION; WALLSTENT; EFFICACY; PATENCY;

D O I：

10.1111/den.13381

中图分类号：

R57 [消化系及腹部疾病];

学科分类号：

摘要：

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-naive 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).

引用

页码：566 / 574

页数：9

共 43 条

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