Department of Gastroenterology, Sendai City Medical Center, Sendai, Japan.
Department of Gastroenterology, Sendai City Medical Center, Sendai, Japan.
Gastrointest Endosc. 2023 Aug;98(2):211-221.e3. doi: 10.1016/j.gie.2023.03.007. Epub 2023 Mar 11.
The efficacy of the suprapapillary placement of inside plastic stents (iPSs) for unresectable malignant hilar biliary obstructions (MHOs) is unknown compared with that of uncovered inside metal stents (iMSs). This randomized controlled trial was designed to evaluate the outcomes of endoscopic placement of these stents for unresectable MHOs.
This open-label, randomized study was conducted at 12 Japanese institutions. The enrolled patients with unresectable MHOs were allocated to iPS and iMS groups. The primary outcome was defined as the time to recurrent biliary obstruction in patients for whom the intervention was both technically and clinically successful.
Among 87 enrollments, 38 patients in the iPS group and 46 patients in the iMS group were analyzed. Technical success rates were 100% (38 of 38) and 96.6% (44 of 46), respectively (P = 1.00). After transferring 1 unsuccessful iMS-group patient to the iPS group (since iPSs were deployed), the clinical success rates were 90.0% (35 of 39) for the iPS group and 88.9% (40 of 45) for the iMS group from a per-protocol analysis (P = 1.00). Among the patients with clinical success, the median times to recurrent biliary obstruction were 250 (95% confidence interval, 85-415) and 361 (95% confidence interval, 107-615) days (log-rank test, P = .34). No differences were detected in rates of adverse events.
This Phase II randomized trial did not show any statistically significant difference in stent patency between suprapapillary plastic versus metal stents. Considering the potential advantages of plastic stents for malignant hilar obstruction, these findings suggest that suprapapillary plastic stents could be a viable alternative to metal stents for this condition.
与 uncovered inside metal stents（iMSs）相比，对于无法切除的恶性肝门胆管梗阻（MHOs），经内镜放置 suprapapillary 内置塑料支架（iPSs）的疗效尚不清楚。本随机对照试验旨在评估这些支架治疗无法切除的 MHOs 的结果。
这是一项在日本 12 家机构进行的开放标签、随机研究。将患有无法切除的 MHOs 的入组患者分配到 iPS 和 iMS 组。主要结局定义为干预技术和临床均成功的患者再次发生胆道梗阻的时间。
在 87 例入组患者中，38 例患者进入 iPS 组，46 例患者进入 iMS 组。技术成功率分别为 100%（38/38）和 96.6%（44/46）（P=1.00）。将 iMS 组 1 例不成功的患者转至 iPS 组（因 iPS 已植入）后，从意向治疗分析来看，iPS 组的临床成功率为 90.0%（35/39），iMS 组为 88.9%（40/45）（P=1.00）。在临床成功的患者中，复发性胆道梗阻的中位时间分别为 250（95%置信区间，85-415）和 361（95%置信区间，107-615）天（对数秩检验，P=0.34）。不良事件发生率无差异。
这项 II 期随机试验未显示支架通畅率在经内镜 suprapapillary 塑料支架与金属支架之间存在统计学显著差异。考虑到恶性肝门部梗阻中塑料支架的潜在优势，这些发现表明，对于这种情况，经内镜 suprapapillary 塑料支架可能是金属支架的可行替代方案。
