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

NCT ID: NCT01944540

Last Updated: 2013-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Brief Summary

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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

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Conditions

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Colorectal Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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conventional ESD

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

Group Type ACTIVE_COMPARATOR

Conventional ESD

Intervention Type PROCEDURE

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.

Group Type EXPERIMENTAL

Optimized ESD with snaring

Intervention Type PROCEDURE

Interventions

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Optimized ESD with snaring

Intervention Type PROCEDURE

Conventional ESD

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jeong-Sik Byeon

Asan Medical Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeong-Sik Byoen, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Asan Medical Center, University of Ulsan College of Medicine

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jeong-Sik Byeon, MD

Role: CONTACT

Phone: +82-2-3010-3905

Email: [email protected]

Facility Contacts

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Jeong-Sik Byeon, MD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 26320696 (View on PubMed)

Other Identifiers

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optESDs2013AMC

Identifier Type: -

Identifier Source: org_study_id