Fully Covered Self-Expandable Metal Stents for the Treatment of Leak After Oncologic Gastroesophageal Surgery: A Cohort Study.

IF 1 Q4 PHARMACOLOGY & PHARMACY Reviews on recent clinical trials Pub Date : 2025-01-01 DOI:10.2174/0115748871324401250114101416
Carmelo Luigiano, Milena Di Leo, Marco Magistroni, Giuseppe Iabichino, Monica Arena, Pierluigi Consolo, Maria Angela Palamara, Ludovico Abenavoli, Luca De Luca
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Abstract

Background: Anastomotic leakages are one of the most frequent complications of gastroesophageal surgery with a high mortality.

Objective: This study aimed to assess the efficacy and safety of endoscopic therapy using fully covered self-expanding metal stents (FC-SEMS) for the management of anastomotic leaks.

Methods: In this cohort study, all patients with leak after oncological gastroesophageal surgery treated with FC-SEMS were included. Procedures were performed by one expert endoscopist in three Italian endoscopic units. The primary outcome was clinical success defined as complete resolution of clinical and laboratory manifestations of sepsis with radiological evidence of leak closure. Secondary outcomes were technical success, stent-related adverse events (AEs), and mortality.

Results: 28 patients (21.4% female, mean age 64.3 years) were included in the study, of whom 17 (60.7%) had undergone total gastrectomy, 9 (32.1%) Ivor-Lewis procedure, and 2 (7.1%) extended gastrectomy (transhiatal-abdominal approach). The leaks were located in esophagogastric anastomosis in 5 patients (17.9%), esophagojejunal anastomosis in 19 (67.9%), and esophagus in 4 (14.3%). A total of 34 stents were placed (mean of 1.2 per patient). Technical success of stent placement was achieved in all cases (100%). Clinical success was observed in 78.6% of patients. Stent-related early AEs occurred in 9 patients (32.1%, all were migration). Late AEs occurred in 21.4%, which all were treated endoscopically.

Conclusion: Stenting therapy using FC-SEMS is a safe and effective modality for the management of anastomotic leaks.

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全覆盖自扩展金属支架治疗肿瘤胃食管手术后渗漏:一项队列研究。
背景:吻合口瘘是胃食管手术最常见的并发症之一,死亡率高。目的:本研究旨在评估内镜下全覆盖自扩张金属支架(FC-SEMS)治疗吻合口瘘的疗效和安全性。方法:本队列研究纳入所有经FC-SEMS治疗的肿瘤胃食管手术后发生漏的患者。手术由一名内窥镜专家在三个意大利内窥镜单位进行。主要结果是临床成功,定义为脓毒症的临床和实验室表现完全解决,放射学证据表明泄漏闭合。次要结局是技术成功、支架相关不良事件(ae)和死亡率。结果:28例患者(女性21.4%,平均年龄64.3岁)纳入研究,其中17例(60.7%)行全胃切除术,9例(32.1%)行Ivor-Lewis手术,2例(7.1%)行扩大胃切除术(经腹入路)。食管胃吻合口5例(17.9%),食管空肠吻合口19例(67.9%),食管4例(14.3%)。总共放置了34个支架(平均每个患者1.2个)。所有病例(100%)支架置入技术成功。临床成功率为78.6%。9例患者发生支架相关的早期不良事件(32.1%,均为迁移)。21.4%发生晚期ae,均经内镜治疗。结论:FC-SEMS支架治疗吻合口瘘是一种安全有效的治疗方法。
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来源期刊
Reviews on recent clinical trials
Reviews on recent clinical trials PHARMACOLOGY & PHARMACY-
CiteScore
3.10
自引率
5.30%
发文量
44
期刊介绍: Reviews on Recent Clinical Trials publishes frontier reviews on recent clinical trials of major importance. The journal"s aim is to publish the highest quality review articles in the field. Topics covered include: important Phase I – IV clinical trial studies, clinical investigations at all stages of development and therapeutics. The journal is essential reading for all researchers and clinicians involved in drug therapy and clinical trials.
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