Back to resultsConventional Endoscopic Mucosal Resection vs Underwater Resection for Colorectal Non-pedunculated Colorectal Lesions
Primary Purpose
Adenoma, Colorectal Neoplasms
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Conventional Endoscopic Mucosal Resection
Underwater Endoscopic Mucosal Resection
Sponsored by
About this trial
This is an interventional treatment trial for Adenoma
Eligibility Criteria
Inclusion Criteria:
- Patients age >18 years with sessile or flat Colorectal Lesions (measuring between 10 and 40mm), who consent to this study
Exclusion Criteria:
- Patients who refuse to participate in the study.
- Patients with pedunculated, depressed or mixed lesions.
- Patients with lesions smaller than 10 mm or larger than 40 mm.
- Patients with lesions that are inflammatory, neuroendocrine or stromal at the pathology.
- Patients with lesions that were submitted to prior attempt to endoscopic resection.
Sites / Locations
- Instituto do Cancer do Estado de Sao Paulo
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Conventional Mucosal Resection
Underwater Mucosal Resection
Arm Description
C-EMR will be made with saline injection with the indigo carmine.
UW-EMR will be made after the complete filling of lumen with water.
Outcomes
Primary Outcome Measures
Technical success rate
Safety (incidence of complications);
Local recurrence.
Secondary Outcome Measures
Resection rate en bloc
Time of resection
Sydney resection ratio (characterized by the following equation - lesion size in millimeters
Full Information
NCT ID
NCT03021135
First Posted
November 4, 2016
Last Updated
June 30, 2023
Sponsor
Instituto do Cancer do Estado de São Paulo
Collaborators
University of Sao Paulo
1. Study Identification
Unique Protocol Identification Number
NCT03021135
Brief Title
Conventional Endoscopic Mucosal Resection vs Underwater Resection for Colorectal Non-pedunculated Colorectal Lesions
Official Title
Conventional Endoscopic Mucosal Resection (With Submucosal Injection) Versus Underwater Endoscopic Mucosal Resection (Without Submucosal Injection) for Colorectal Non-pedunculated Colorectal Lesions
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
June 7, 2018 (Actual)
Primary Completion Date
January 19, 2022 (Actual)
Study Completion Date
January 19, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto do Cancer do Estado de São Paulo
Collaborators
University of Sao Paulo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Randomized, comparative and prospective study between Conventional Endoscopic Mucosal Resection for the removal of flat or sessile colorectal lesions without previous attempt to resection.
Detailed Description
This prospective randomized trial was conducted in 2 academic services: Instituto do Câncer do Estado de São Paulo and Centro de Diagnóstico em Gastroenterologia, both linked to the University of São Paulo. The clinical study was performed in accordance to the Declaration of Helsinki.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenoma, Colorectal Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
105 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional Mucosal Resection
Arm Type
Active Comparator
Arm Description
C-EMR will be made with saline injection with the indigo carmine.
Arm Title
Underwater Mucosal Resection
Arm Type
Experimental
Arm Description
UW-EMR will be made after the complete filling of lumen with water.
Intervention Type
Procedure
Intervention Name(s)
Conventional Endoscopic Mucosal Resection
Other Intervention Name(s)
EMR
Intervention Description
Conventional Endoscopic Mucosal Resection
Intervention Type
Procedure
Intervention Name(s)
Underwater Endoscopic Mucosal Resection
Other Intervention Name(s)
U-EMR
Intervention Description
Underwater Endoscopic Mucosal Resection
Primary Outcome Measure Information:
Title
Technical success rate
Time Frame
three years
Title
Safety (incidence of complications);
Time Frame
three years
Title
Local recurrence.
Time Frame
Four years
Secondary Outcome Measure Information:
Title
Resection rate en bloc
Time Frame
three years
Title
Time of resection
Time Frame
Three years
Title
Sydney resection ratio (characterized by the following equation - lesion size in millimeters
Time Frame
Three years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients age >18 years with sessile or flat Colorectal Lesions (measuring between 10 and 40mm), who consent to this study
Exclusion Criteria:
Patients who refuse to participate in the study.
Patients with pedunculated, depressed or mixed lesions.
Patients with lesions smaller than 10 mm or larger than 40 mm.
Patients with lesions that are inflammatory, neuroendocrine or stromal at the pathology.
Patients with lesions that were submitted to prior attempt to endoscopic resection.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luciano Lenz, PhD
Organizational Affiliation
Cancer Institute of the state of São Paulo (ICESP)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto do Cancer do Estado de Sao Paulo
City
Sao Paulo
ZIP/Postal Code
01246-000
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://doi.org/10.1016/j.gie.2022.10.033
Description
Results
Learn more about this trial
Conventional Endoscopic Mucosal Resection vs Underwater Resection for Colorectal Non-pedunculated Colorectal Lesions
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