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Trial Title:
Brief Title : Optimized Endoscopic Submucosal Dissection With Snaring for Colorectal Neoplasm
NCT ID:
NCT01944540
Condition:
Colorectal Neoplasms
Conditions: Official terms:
Neoplasms
Colorectal Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Participant)
Intervention:
Intervention type:
Procedure
Intervention name:
Optimized ESD with snaring
Arm group label:
Optimized ESD with snaring
Intervention type:
Procedure
Intervention name:
Conventional ESD
Arm group label:
conventional ESD
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Asan Medical Center, University of Ulsan College of Medicine
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Jeong-Sik Byeon, MD
Phone:
+82-2-3010-3905
Email:
jsbyeon@amc.seoul.kr
Start date:
August 2013
Lead sponsor:
Agency:
Asan Medical Center
Agency class:
Other
Source:
Asan Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01944540