Brief Title : Optimized Endoscopic Submucosal Dissection With Snaring for Colorectal Neoplasm

Not Applicable

• Conditions: Colorectal Neoplasms
• Interventions: Procedure: Conventional ESD; Procedure: Optimized ESD with snaring

• Registration Number: NCT01944540
• Lead Sponsor: Asan Medical Center

Brief Summary

This study is aimed to analyze the outcomes after conventional endoscopic submucosal dissection (ESD) and optimized ESD with snaring (oESD-S) for colorectal neoplasm that is more than 20 mm in diameter of laterllay spreading tumor or flat elevated lesion without stalk.

Optimized ESD with snaring means submucosal dissection followed by snaring when narrowed circumference of the remained submucosal tissue beneath the lesion is less than 5 mm in diameter with snaring, then resected by using an electric current.

The investigators expect optimized ESD with snaring can provide more time-saving procedure with comparable en-bloc resection rate and perforation rate, when compared with the conventional ESD method.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Status Verified: 2013-09
• Study First Submitted: 2013-09-13
• Study First Submitted QC: 2013-09-16
• Last Update Submitted: 2013-09-16
• Study First Posted: 2013-09-17
• Last Update Posted: 2013-09-17
• Primary Completion: 2014-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• colorectal laterally spreading tumor that is more than 20 mm in diameter
• other elevated or flat colorectal neoplasm without stalk, that is more than 20 mm in diameter

Exclusion Criteria

• colorectal neoplasms that are proven or suspected to be invaded more than submucosal invasion
• colorectal neoplasms that have severe fibrosis beneath the target lesion
• patient's refusal to participate this study
• less than 18 years old
• subjects who cannot consent voluntarily due to the communication difficulty

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conventional ESD	Conventional ESD	Conventional ESD arm indicates the group in which conventional ESD method is applied for the dissection of colorectal neoplasm.
Optimized ESD with snaring	Optimized ESD with snaring	Optimized ESD with snaring arm indicates the group in which optimized ESD with snaring method is applied for the dissection of colorectal neoplasm.

Primary Outcome Measures

Name	Time	Method
En Bloc resection rate	8 months
procedure time	8 months

Secondary Outcome Measures

Name	Time	Method
histologic complete resection rate	8 months
complication rate	8 months	perforation rate, bleeding rate

Trial Locations

Locations (1)

Asan Medical Center, University of Ulsan College of Medicine; 🇰🇷 Seoul, Korea, Republic of