Brief Title : Optimized Endoscopic Submucosal Dissection With Snaring for Colorectal Neoplasm
Primary Purpose
Colorectal Neoplasms
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Optimized ESD with snaring
Conventional ESD
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Neoplasms
Eligibility 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
Sites / Locations
- Asan Medical Center, University of Ulsan College of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
conventional ESD
Optimized ESD with snaring
Arm Description
Conventional ESD arm indicates the group in which conventional ESD method is applied for the dissection of colorectal neoplasm.
Optimized ESD with snaring arm indicates the group in which optimized ESD with snaring method is applied for the dissection of colorectal neoplasm.
Outcomes
Primary Outcome Measures
procedure time
En Bloc resection rate
Secondary Outcome Measures
histologic complete resection rate
complication rate
perforation rate, bleeding rate
Full Information
NCT ID
NCT01944540
First Posted
September 13, 2013
Last Updated
September 16, 2013
Sponsor
Asan Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01944540
Brief Title
Brief Title : Optimized Endoscopic Submucosal Dissection With Snaring for Colorectal Neoplasm
Official Title
Comparison of Coventional Endoscopic Submucosal Dissection and Optimized Endoscopic Submucosal Dissection With Snaring for Colorectal Neoplasm
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Unknown status
Study Start Date
August 2013 (undefined)
Primary Completion Date
March 2014 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
conventional ESD
Arm Type
Active Comparator
Arm Description
Conventional ESD arm indicates the group in which conventional ESD method is applied for the dissection of colorectal neoplasm.
Arm Title
Optimized ESD with snaring
Arm Type
Experimental
Arm Description
Optimized ESD with snaring arm indicates the group in which optimized ESD with snaring method is applied for the dissection of colorectal neoplasm.
Intervention Type
Procedure
Intervention Name(s)
Optimized ESD with snaring
Intervention Type
Procedure
Intervention Name(s)
Conventional ESD
Primary Outcome Measure Information:
Title
procedure time
Time Frame
8 months
Title
En Bloc resection rate
Time Frame
8 months
Secondary Outcome Measure Information:
Title
histologic complete resection rate
Time Frame
8 months
Title
complication rate
Description
perforation rate, bleeding rate
Time Frame
8 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeong-Sik Byeon, MD
Phone
+82-2-3010-3905
Email
jsbyeon@amc.seoul.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeong-Sik Byoen, MD
Organizational Affiliation
Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center, University of Ulsan College of Medicine
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeong-Sik Byeon, MD
Phone
+82-2-3010-3905
Email
jsbyeon@amc.seoul.kr
12. IPD Sharing Statement
Citations:
PubMed Identifier
26320696
Citation
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.
Results Reference
derived
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Brief Title : Optimized Endoscopic Submucosal Dissection With Snaring for Colorectal Neoplasm
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