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

Colorectal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01944540
• Other study ID #: optESDs2013AMC
• Status: Recruiting
• Phase: N/A
• First received: September 13, 2013
• Last updated: September 16, 2013
• Start date: August 2013

Study information

• Verified date: September 2013
• Source: Asan Medical Center
• Contact: Jeong-Sik Byeon, MD
• Phone: +82-2-3010-3905
• Email: jsbyeon[@]amc.seoul.kr
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Neoplasms

Intervention

Procedure:
• Optimized ESD with snaring

• Conventional ESD

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center, University of Ulsan College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	procedure time		8 months	No
Primary	En Bloc resection rate		8 months	No
Secondary	histologic complete resection rate		8 months	No
Secondary	complication rate	perforation rate, bleeding rate	8 months	Yes