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

NCT01944540 | Unknown

• 1 other identifier: optESDs2013AMC
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Neoplasms

Outcome Measures

Primary Outcomes (2)

• procedure time

  8 months

• En Bloc resection rate

  8 months

Secondary Outcomes (2)

• histologic complete resection rate

  8 months

• complication rate

  8 months

Study Arms (2)

conventional ESD

ACTIVE COMPARATOR

Conventional ESD arm indicates the group in which conventional ESD method is applied for the dissection of colorectal neoplasm.

Procedure: Conventional ESD

Optimized ESD with snaring

EXPERIMENTAL

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

Procedure: Optimized ESD with snaring

Interventions

Optimized ESD with snaring PROCEDURE

Optimized ESD with snaring

Conventional ESD PROCEDURE

conventional ESD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center, University of Ulsan College of Medicine

Seoul, South Korea

RECRUITING

Related Publications (1)

• Bae JH, Yang DH, Lee S, Soh JS, Lee S, Lee HS, Lee HJ, Park SH, Kim KJ, Ye BD, Myung SJ, Yang SK, Byeon JS. Optimized hybrid endoscopic submucosal dissection for colorectal tumors: a randomized controlled trial. Gastrointest Endosc. 2016 Mar;83(3):584-92. doi: 10.1016/j.gie.2015.06.057. Epub 2015 Aug 28.

  PMID: 26320696 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Jeong-Sik Byoen, MD

  Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeong-Sik Byeon, MD

CONTACT

+82-2-3010-3905; jsbyeon@amc.seoul.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asan Medical Center

Study Record Dates

• First Submitted: September 13, 2013
• First Posted: September 17, 2013
• Study Start: August 1, 2013
• Primary Completion: March 1, 2014
• Last Updated: September 17, 2013

Record last verified: 2013-09

Locations

KR (1)