Brief Title : Optimized Endoscopic Submucosal Dissection With Snaring for Colorectal Neoplasm
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|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|
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
- procedure time [ Time Frame: 8 months ]
- En Bloc resection rate [ Time Frame: 8 months ]
- histologic complete resection rate [ Time Frame: 8 months ]
- complication rate [ Time Frame: 8 months ]perforation rate, bleeding rate
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
|Contact: Jeong-Sik Byeon, MDfirstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator:||Jeong-Sik Byoen, MD||Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea|