Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, South Korea.
Department of Internal Medicine, Catholic University of Daegu School of Medicine, Daegu, South Korea.
Surg Endosc. 2021 Aug;35(8):4124-4133. doi: 10.1007/s00464-020-07869-x. Epub 2020 Aug 13.
Stent migration is one of the main drawbacks of covered self-expandable metal stent (SEMSs), occurring in up to 40% of malignant colorectal obstruction management cases. Various types of covered SEMSs have been developed to reduce this risk. We aimed to compare the effectiveness and complication rates of the flare-type covered SEMS (Flare) with those of the double-layered covered SEMS (ComVi).
We performed a prospective, randomized study in four tertiary referral centers between July 2016 and April 2018. Patients with malignant colorectal obstruction were eligible for the study. The primary outcome was migration rate as observed within the first month. Rates of technical success, clinical success, and complications within the first month were also assessed.
A total of 60 patients were included (mean age, 70.5 ± 12.5 years; male, 31 [51.7%]). Flare and ComVi stents were applied in 30 patients each. The Flare and ComVi groups showed comparable technical success rates (90% [27/30] vs. 96.7% [29/30], p = 0.605) and clinical success rates (85.2% [23/27] vs. 75.9% [22/29], p = 0.589). Migration occurred in three (11.1%) and four (13.8%) cases in the Flare and ComVi groups, respectively, without significant difference (p = 0.99), and the risk of other complications, including perforation and re-obstruction, did not differ between the two groups.
Our study indicates that both flare-shape and double-layered covered SEMSs are equally effective options for the management of malignant colorectal obstruction with low migration rates when compared with previously reported migration risk of covered SEMS.
支架迁移是覆盖自膨式金属支架（SEMS）的主要缺点之一，在多达 40%的恶性结直肠梗阻管理病例中发生。已经开发了各种类型的覆盖 SEMS 以降低这种风险。我们旨在比较 flare 型覆盖 SEMS（Flare）与双层覆盖 SEMS（ComVi）的有效性和并发症发生率。
我们在 2016 年 7 月至 2018 年 4 月期间在四个三级转诊中心进行了一项前瞻性、随机研究。患有恶性结直肠梗阻的患者符合研究条件。主要结果是在第一个月内观察到的迁移率。还评估了第一个月内的技术成功率、临床成功率和并发症发生率。
共有 60 名患者入选（平均年龄 70.5±12.5 岁；男性 31 名[51.7%]）。Flare 和 ComVi 支架分别应用于 30 名患者。Flare 和 ComVi 组的技术成功率（90%[27/30]与 96.7%[29/30]，p=0.605）和临床成功率（85.2%[23/27]与 75.9%[22/29]，p=0.589）相当。在 Flare 和 ComVi 组中，分别有 3 例（11.1%）和 4 例（13.8%）发生迁移，但无显著差异（p=0.99），并且两组之间其他并发症（包括穿孔和再梗阻）的风险也没有差异。
我们的研究表明，与先前报道的覆盖 SEMS 迁移风险相比，flare 型和双层覆盖 SEMS 对于恶性结直肠梗阻的管理都是同样有效的选择，其迁移率较低。
