Department of Gastroenterology and Nephrology, Graduate School of Medicine, Chiba University, Chiba, Japan.
Department of Gastroenterology, Tokai University Hospital, Iseahara, Japan.
Scand J Gastroenterol. 2021 Oct;56(10):1229-1235. doi: 10.1080/00365521.2021.1938207. Epub 2021 Aug 10.
The treatment result of the uncovered metallic stent (uncovered MS) and covered metallic stent (covered MS) for unresectable malignant distal biliary obstruction is controversial. This time, we conducted this study to compare the efficacies and complication rates of uncovered MS and covered MS in unresectable malignant distal biliary obstructions at a prospective randomized multicenter trial.
From April 2014 to September 2018, patients with unresectable malignant distal biliary obstruction were randomly assigned to 2 groups: the uncovered MS group and the covered MS group.
92 treatment results patients were discussed. 48 patients were assigned to the uncovered MS group and 44 cases were assigned to the covered MS group. Both groups showed a drainage effect. No significant difference was found in the drainage effect between the 2 groups. The number of stent occlusion was significantly greater ( = .0467) in uncovered MS (43.8%) comparing with those in covered MS (22.7%). As the cause of stent occlusion, tumor ingrowth was significantly greater ( < .001) in the uncovered MS group (35.4%) than in the covered MS group (2.3%). The median stent patency period was significantly longer ( = .0112) in the covered MS group (455 days) than that of the uncovered MS group (301 days). A significant difference in the median survival period was not found between the 2 groups.
Covered MS showed the possibility of extending the stent patency period by suppressing tumor ingrowth more than uncovered MS does. The UMIN Clinical Trial Registry number is UMIN000015093.
对于无法切除的恶性远端胆道梗阻，uncovered MS（无覆膜金属支架）和 covered MS（覆膜金属支架）的治疗效果存在争议。本研究旨在通过前瞻性随机多中心试验，比较无法切除的恶性远端胆道梗阻患者使用 uncovered MS 和 covered MS 的疗效和并发症发生率。
自 2014 年 4 月至 2018 年 9 月，将无法切除的恶性远端胆道梗阻患者随机分为 2 组：uncovered MS 组和 covered MS 组。
共讨论了 92 例治疗结果患者。48 例患者被分配到 uncovered MS 组，44 例患者被分配到 covered MS 组。两组均显示出引流效果。两组间引流效果无显著差异。uncovered MS 组支架闭塞的数量明显更多（=0.0467）（43.8%），而 covered MS 组支架闭塞的数量明显较少（22.7%）。作为支架闭塞的原因，uncovered MS 组（35.4%）的肿瘤生长明显多于 covered MS 组（2.3%）。covered MS 组的中位支架通畅期明显较长（=0.0112）（455 天），而 uncovered MS 组的中位支架通畅期明显较短（301 天）。两组的中位生存时间无显著差异。
覆膜 MS 可通过抑制肿瘤生长，比 uncovered MS 更有可能延长支架通畅期。UMIN 临床试验注册编号为 UMIN000015093。
