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混合式与传统结直肠内镜黏膜下剥离术:一项多中心随机对照试验(短内镜黏膜下剥离术)

Hybrid Versus Conventional Colorectal Endoscopic Submucosal Dissection: A Multicenter Randomized Controlled Trial (Short-Endoscopic Submucosal Dissection).

作者信息

Yang Dennis, Hasan Muhammad K, Jawaid Salmaan, Singh Gurdeep, Xiao Yasi, Khalaf Mai, Tomizawa Yutaka, Sharma Neil S, Draganov Peter V, Othman Mohamed O

机构信息

Center for Interventional Endoscopy, AdventHealth, Orlando, Florida, USA.

Division of Gastroenterology and Hepatology, Baylor College of Medicine, Houston, Texas, USA.

出版信息

Am J Gastroenterol. 2024 Dec 1;119(12):2436-2443. doi: 10.14309/ajg.0000000000002897. Epub 2024 Jun 24.

DOI:10.14309/ajg.0000000000002897
PMID:38912697
Abstract

INTRODUCTION

Hybrid endoscopic submucosal dissection (H-ESD), which utilizes ESD knife along with snare-based resection, has been developed to overcome the technical complexity of conventional ESD (C-ESD). The aim of this study was to compare the therapeutic outcomes of H-ESD vs C-ESD for nonpedunculated colorectal lesions ≥20 mm in size.

METHODS

We conducted a multicenter randomized controlled trial to compare H-ESD and C-ESD (Short-ESD trial). Patients with colorectal lesions between 20 and 50 mm in size were randomly assigned (1:1) to H-ESD or C-ESD. Primary outcome was procedure time/speed. Secondary outcomes were en bloc and complete (R0) resection rates and adverse event rates.

RESULTS

A total of 89 patients (median age 63 years; 49.3% women) with the median polyp size of 30 mm underwent H-ESD (n = 40) and C-ESD (n = 49). The mean procedure time of H-ESD was significantly shorter than that of C-ESD (41.1 ± 16.3 vs 54.3 ± 28.2 minutes; P = 0.007). The en bloc and R0 resection rates trended lower in the H-ESD vs C-ESD groups (77.5% vs 87.8%; P = 0.26% and 72.5% vs 79.6%; P = 0.46) without reaching statistical significance. Adverse event rate was similar between H-ESD and C-ESD (10% vs 8.2%; P = 1.00).

DISCUSSION

Both H-ESD and C-ESD were safe and effective for resection of large colorectal lesions. H-ESD was associated with a shorter procedure time. H-ESD may represent a viable alternative to C-ESD, with the main advantage being easy applicability of a snare-based technique for colorectal lesions. Future studies are needed to further define the most suitable lesions for H-ESD, as to optimize efficiency and safety without compromising resection outcomes. ClinicaTrials.gov NCT NCT05347446.

摘要

引言

混合内镜黏膜下剥离术(H-ESD)利用内镜黏膜下剥离刀结合圈套器切除术,旨在克服传统内镜黏膜下剥离术(C-ESD)的技术复杂性。本研究的目的是比较H-ESD与C-ESD治疗直径≥20mm的无蒂结直肠病变的疗效。

方法

我们进行了一项多中心随机对照试验,比较H-ESD和C-ESD(Short-ESD试验)。将大小在20至50mm之间的结直肠病变患者随机分配(1:1)至H-ESD组或C-ESD组。主要结局是手术时间/速度。次要结局是整块切除率和完整(R0)切除率以及不良事件发生率。

结果

共有89例患者(中位年龄63岁;49.3%为女性),息肉中位大小为30mm,接受了H-ESD(n = 40)和C-ESD(n = 49)。H-ESD的平均手术时间明显短于C-ESD(41.1±16.3分钟对54.3±28.2分钟;P = 0.007)。H-ESD组的整块切除率和R0切除率与C-ESD组相比呈下降趋势(77.5%对87.8%;P = 0.26%以及72.5%对79.6%;P = 0.46),未达到统计学意义。H-ESD和C-ESD的不良事件发生率相似(10%对8.2%;P = 1.00)。

讨论

H-ESD和C-ESD对于切除大的结直肠病变均安全有效。H-ESD的手术时间较短。H-ESD可能是C-ESD的一种可行替代方法,主要优点是基于圈套器的技术对结直肠病变易于应用。未来需要进一步研究以确定最适合H-ESD的病变,从而在不影响切除效果的情况下优化效率和安全性。ClinicalTrials.gov NCT NCT05347446。

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