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临床试验/NCT03180788
NCT03180788撤回不适用

The Impact of Traction Assisted ESD on Procedural Time, En Bloc Resection, Curative Resection and Complication Incidence

Region Skane1 个研究点 分布在 1 个国家开始时间: 2018年1月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
发起方
Region Skane
试验地点
1
主要终点
Procedural time

研究概览

简要总结

The aim of this study is to evaluate the role of traction assisted ESD in comparison to traditional ESD on procedural time and outcome in patients with large, non pedunculated colorectal polyps.

详细描述

Endoscopic polypectomy, has been proven to reduce Colorectal cancer incidence and mortality. Smaller lesions and pedunculated lesions can be removed by conventional polypectomy, Endoscopic mucosa resection (EMR). However, large sessile and flat lesions are difficult to remove En bloc with EMR, resulting in a high level of tumor recurrence. Endoscopic submucosal dissection (ESD) was developed during the 1990s in Japan to achieve En bloc resection of large neoplasms in the stomach but has in recent years also been extended into management of large (>2 cm) and technically challenging colorectal polyps. Large series on the efficacy of ESD in removing benign lesions show high En bloc resection rates resulting in low numbers of recurrences. Traction assisted ESD was developed in Japan to further improve the technique and reduce procedural time, the literature on the efficacy of traction assisted ESD is however scarce and limited to Japanese studies.

The aim in this study is to investigate the impact of this novel technique in comparison to traditional ESD on procedural time, En bloc resection rate, R0 resection rate and complication incidence.

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 (Investigator)

盲法说明

Randomisation to either traction assisted ESD or traditional ESD

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •> 2cm, flat or sessile colorectal polyp

排除标准

  • •Recurrencies.

研究组 & 干预措施

Traction assisted ESD

Experimental

The patients in this Group will undergo traction assisted ESD

干预措施: Traction assisted ESD (Procedure)

Traditional ESD

Active Comparator

The patients in this Group will undergo traditional ESD.

干预措施: Traditional ESD (Procedure)

结局指标

主要结局

Procedural time

时间窗: 280 min, procedural time

Time consumption to complete the resection is measured.

次要结局

  • En bloc resection(280 min, procedural time)
  • Complication incidence(2 weeks, when the timeframe for delayed complications is over.)
  • R0 resection(4-8 weeks, when pathological examination is completed)

研究者

发起方
Region Skane
申办方类型
Other
责任方
Sponsor

研究点 (1)

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