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Clinical Trials/NCT01944540
NCT01944540
Unknown
Not Applicable

Comparison of Coventional Endoscopic Submucosal Dissection and Optimized Endoscopic Submucosal Dissection With Snaring for Colorectal Neoplasm

Asan Medical Center1 site in 1 country70 target enrollmentAugust 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colorectal Neoplasms
Sponsor
Asan Medical Center
Enrollment
70
Locations
1
Primary Endpoint
procedure time
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2013
End Date
March 2014
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jeong-Sik Byeon

Asan Medical Center

Asan Medical Center

Eligibility Criteria

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

Outcomes

Primary Outcomes

procedure time

Time Frame: 8 months

En Bloc resection rate

Time Frame: 8 months

Secondary Outcomes

  • histologic complete resection rate(8 months)
  • complication rate(8 months)

Study Sites (1)

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