Department of Internal Medicine II-Gastroenterology and Geriatrics, Faculty of Medicine and Dentistry, Palacky University Olomouc and University Hospital Olomouc, Olomouc, Czech Republic.
Beskydske Gastrocentrum, Frydek-Mistek Hospital, Frydek-Mistek, Czech Republic; Faculty of Medicine, University of Ostrava, Ostrava, Czech Republic.
Gastrointest Endosc. 2023 Jun;97(6):1070-1080. doi: 10.1016/j.gie.2022.12.026. Epub 2023 Jan 13.
Lumen-apposing metal stents (LAMSs) have proven to be effective for drainage of pancreatic walled-off necrosis (WON), although associated adverse events (AEs) have been reported. Anchoring coaxial double-pigtail plastic stents (DPSs) within LAMSs have been proposed to prevent LAMS-related AEs but have not been assessed in prospective studies. We aimed to evaluate the utility of such measures with a randomized controlled trial.
We randomly assigned consecutive patients with WON indications for drainage to EUS-guided transluminal drainage using LAMSs with (group A) or without (group B) DPSs. All LAMSs were to be removed after 3 weeks had elapsed from the index procedure with a preceding CT to decide whether additional steps needed to be taken (eg, transluminal necrosectomy or placing transluminal plastic stents in patients with incomplete resolution of WON). The main outcomes were failure of the index method, defined as necessity of reintervention (endoscopic, percutaneous, or surgical) before LAMS removal because of LAMS-related AEs and/or clinical deterioration; AE rates; and mortality with the LAMS in place. Variables were evaluated using the Mann-Whitney U test, χ test, or Fisher exact test as appropriate. P < .05 was considered significant.
Sixty-seven patients (37.3% women; mean age, 54 ± 14.4 years) underwent LAMS placement with (n = 34) or without (n = 33) DPS placement in 2 tertiary centers. Baseline characteristics including demographics, etiology, comorbidity, and clinical presentation (sterile vs infected necrosis) were comparable between both groups. The technical success rate in placing LAMSs and DPSs was 100%. The global rate of AEs was significantly lower in group A versus group B (20.7% vs 51.5%, respectively; P = .008). Stent occlusion was the most frequently observed AE (14.7% vs 36.3%, P = .042). Failure of the index method was lower in group A versus group B (29.4% vs 48.5%, respectively; P = .109); however, the difference did not achieve statistical significance. The same applied to the mortality rate with LAMSs in place (2.9% vs 12.1%, P = .197).
The addition of a coaxial DPS within a LAMS was associated with a significantly lower global rate of AEs and stent occlusion rate in EUS-guided drainage of WON. (Clinical trial registration number: NCT03923686.).
腔内置入型金属支架（LAMS）已被证明对胰腺包裹性坏死（WON）的引流有效，尽管已有相关不良事件（AE）的报道。在 LAMS 内锚定同轴双猪尾塑料支架（DPS）被提议用于预防与 LAMS 相关的 AE，但尚未在前瞻性研究中进行评估。我们旨在通过随机对照试验来评估这些措施的实用性。
我们连续随机分配有 WON 引流适应证的患者进行 EUS 引导下经腔引流，使用带有（A 组）或不带有（B 组）DPS 的 LAMS。所有 LAMS 均在指数操作后 3 周内取出，同时进行 CT 检查，以决定是否需要进一步治疗（例如，经腔内坏死组织清除术或在 WON 不完全缓解的患者中放置经腔内塑料支架）。主要结局是索引方法失败，定义为由于与 LAMS 相关的 AE 和/或临床恶化而需要（内镜、经皮或手术）再次干预之前 LAMS 取出；AE 发生率；以及 LAMS 在位时的死亡率。使用 Mann-Whitney U 检验、χ检验或 Fisher 确切检验评估变量，P<.05 被认为具有统计学意义。
在 2 个三级中心，共 67 例患者（37.3%为女性；平均年龄 54±14.4 岁）接受了 LAMS 放置，其中 34 例（n=34）放置了 DPS，33 例（n=33）未放置 DPS。两组之间的基线特征包括人口统计学、病因、合并症和临床表现（无菌性与感染性坏死）均相似。LAMS 和 DPS 放置的技术成功率均为 100%。A 组的总体 AE 发生率明显低于 B 组（分别为 20.7%和 51.5%，P=.008）。支架闭塞是最常观察到的 AE（14.7% vs 36.3%，P=.042）。A 组索引方法失败的发生率低于 B 组（分别为 29.4%和 48.5%，P=.109）；然而，差异没有达到统计学意义。同样适用于 LAMS 在位时的死亡率（分别为 2.9%和 12.1%，P=.197）。
在 EUS 引导下引流 WON 时，在 LAMS 内增加同轴 DPS 与 AE 发生率和支架闭塞率的显著降低相关。（临床试验注册号：NCT03923686.）
