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

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ClinicalTrials.gov Identifier: NCT01944540
Recruitment Status : Unknown
Verified September 2013 by Jeong-Sik Byeon, Asan Medical Center.
Recruitment status was:  Recruiting
First Posted : September 17, 2013
Last Update Posted : September 17, 2013
Sponsor:
Information provided by (Responsible Party):
Jeong-Sik Byeon, 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.


Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Procedure: Optimized ESD with snaring Procedure: Conventional ESD Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Comparison of Coventional Endoscopic Submucosal Dissection and Optimized Endoscopic Submucosal Dissection With Snaring for Colorectal Neoplasm
Study Start Date : August 2013
Estimated Primary Completion Date : March 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: conventional ESD
Conventional ESD arm indicates the group in which conventional ESD method is applied for the dissection of colorectal neoplasm.
Procedure: Conventional ESD
Experimental: 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.
Procedure: Optimized ESD with snaring



Primary Outcome Measures :
  1. procedure time [ Time Frame: 8 months ]
  2. En Bloc resection rate [ Time Frame: 8 months ]

Secondary Outcome Measures :
  1. histologic complete resection rate [ Time Frame: 8 months ]
  2. complication rate [ Time Frame: 8 months ]
    perforation rate, bleeding rate



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01944540


Contacts
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Contact: Jeong-Sik Byeon, MD +82-2-3010-3905 jsbyeon@amc.seoul.kr

Locations
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Korea, Republic of
Asan Medical Center, University of Ulsan College of Medicine Recruiting
Seoul, Korea, Republic of
Contact: Jeong-Sik Byeon, MD    +82-2-3010-3905    jsbyeon@amc.seoul.kr   
Sponsors and Collaborators
Asan Medical Center
Investigators
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Principal Investigator: Jeong-Sik Byoen, MD Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jeong-Sik Byeon, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01944540     History of Changes
Other Study ID Numbers: optESDs2013AMC
First Posted: September 17, 2013    Key Record Dates
Last Update Posted: September 17, 2013
Last Verified: September 2013

Additional relevant MeSH terms:
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Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases