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临床试验/NCT07490574
NCT07490574已完成不适用

UNDERWATER VERSUS CONVENTIONAL ENDOSCOPIC SUBMUCOSAL DISSECTION FOR COLORECTAL NEOPLASIA: A MULTICENTER, RANDOMISED CONTROLLED TRIAL

University of Roma La Sapienza1 个研究点 分布在 1 个国家目标入组 295 人开始时间: 2024年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
295
试验地点
1
主要终点
En bloc resection rate

研究概览

简要总结

Colorectal endoscopic submucosal dissection (ESD) enables en bloc resection of large superficial colorectal neoplasia but remains technically demanding and may be limited by suboptimal visualization, intraprocedural bleeding, smoke accumulation, and prolonged procedural time. Underwater ESD (UESD), performed under saline immersion rather than gas insufflation, has been proposed as a strategy to improve the operative field and facilitate submucosal dissection.

This prospective, multicenter, open-label, randomized controlled trial was designed to compare UESD with conventional gas-assisted ESD (GESD) for colorectal neoplasia referred for ESD across Italian tertiary centers. The primary objective was to assess non-inferiority of UESD versus GESD in terms of en bloc resection. Secondary objectives included comparison of histological resection quality, procedural efficiency, intraprocedural events, procedural field visualization, and post-procedural adverse events.

详细描述

Colorectal ESD is an established organ-preserving technique for the en bloc resection of superficial colorectal neoplasia, particularly when conventional endoscopic mucosal resection is unlikely to achieve complete single-piece excision. However, colorectal ESD is technically demanding because of the thin colonic wall, unstable scope position, narrow submucosal space, intraprocedural bleeding, smoke generation, and difficulty in maintaining a stable dissection plane.

Underwater ESD has emerged as a modified operative environment in which luminal insufflation is discontinued and the target segment is immersed in saline. Saline immersion may improve visualization of the submucosal layer and of submucosal vessels, limit smoke persistence in the operative field, and facilitate more stable dissection. Although initial retrospective and comparative experiences have suggested procedural advantages of underwater ESD, high-quality randomized comparative data remain limited, particularly in Western multicenter practice.

This study was therefore designed as a prospective multicenter randomized trial across Italian tertiary referral centers to compare underwater ESD with conventional gas-assisted ESD for colorectal neoplasia referred for ESD. Patients were allocated 1:1 to either UESD or GESD. The primary endpoint was en bloc resection. Secondary endpoints included R0 resection, procedural time, dissection speed, intraprocedural bleeding, need for hemostatic forceps, smoke interference, vessel visualization, cutting-plane visualization, post-procedural pain, post-ESD coagulation syndrome, perforation, and delayed bleeding. The technical conduct of ESD apart from the assigned luminal environment was left to expert operator discretion in order to preserve real-world tertiary-center practice.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 19 years or older
  • Colorectal neoplastic lesion referred for endoscopic submucosal dissection
  • Lesion considered amenable to en bloc endoscopic resection by ESD according to expert pre-procedural endoscopic assessment
  • Written informed consent provided

排除标准

  • Known or suspected deep invasive neoplasia
  • Inflammatory bowel disease
  • Uninterrupted antithrombotic therapy
  • Known coagulopathy
  • Any clinical or lesion-related condition considered unsuitable for colorectal ESD by the treating endoscopist

结局指标

主要结局

En bloc resection rate

时间窗: During the index procedure

Proportion of lesions resected in a single specimen.

次要结局

  • Intraprocedural bleeding rate(During the index procedure)
  • Use of hemostatic forceps(During the index procedure)
  • R0 resection rate(During index procedure and histopathological assessment within 30 days)
  • Procedural time(During the index procedure)
  • Dissection speed(During the index procedure)
  • Smoke interference(During the index procedure)
  • Vessel visualization score(Immediately after the index procedure)
  • Cutting-plane visualization score(Immediately after the index procedure)
  • Post-procedural abdominal pain(15, 30, and 60 minutes after the procedure)
  • Post-ESD coagulation syndrome (PECS)(Within 7 days)
  • Perforation rate(From procedure to 30 days)
  • Delayed bleeding rate(From procedure to 30 days)

研究者

发起方
University of Roma La Sapienza
申办方类型
Other
责任方
Principal Investigator
主要研究者

Giulio Antonelli

MD, PhD

University of Roma La Sapienza

研究点 (1)

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