Endoscopic Submucosal Dissection (ESD) Versus Endoscopic Mucosal Resection (EMR) for Large Non Pedunculated Colonic Adenomas: a Randomized Comparative Trial (RESECT COLON)
Primary Purpose
Colonic Polyp
Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Experimental procedure : ESD
Comparison procedure: WF-piece meal EMR
Sponsored by
About this trial
This is an interventional treatment trial for Colonic Polyp focused on measuring Colonic Polyp, large non pedunculated, colonic adenoma, Endoscopic submucosal dissection, Endoscopic Mucosal Resection
Eligibility Criteria
Inclusion Criteria:
- Patient suffering from non-pedunculated polyp suspected larger than 25 mm in the colon
- Colon localization beyond 15 cm of the anal margin.
- Indication for endoscopic treatment
- Patients aged ≥ 18 years old
- Patients able to fill in questionnaires written in French
Exclusion Criteria:
- Prior endoscopic resection attempt
- Contra-indication to colonoscopy
- Contra-indication to general anesthesia
- Inability to stop antiplatelet agents and anti-coagulant according to the European Society of Gastro-Intestinal Endoscopy guidelines.
- Recurrent adenoma: post-endoscopic or surgical resection
- Pregnant or lactating women
- Genetic polyposis (Familial Adenomatous Polyposis, Lynch Syndrome, Peutz-Jeghers Syndrome)
- Inability to provide informed consent
- Patient under legal protection and or deprived of liberty by judicial or administrative decision
- Patient already participating in an interventional clinical research protocol
- Patient who cannot be followed for the duration of the study
- Non-pedunculated polyp ≤ 25 mm
- More than one lesion > 25 mm that fulfilled the inclusion criteria
- Suspicion of deep submucosal cancer by analysis of macroscopic appearance (Paris 0-III), vascular pattern and pit pattern (SANO IIIB, KUDO Vn)
- Non granular pseudodepressed Laterally spreading tumors due to the high risk of nonvisible submucosal cancer
- Polyp involving the appendice deeply (type 2 or 3 of classification of Toyonaga)
- Polyp inside the ileo-caecal valvula
- Tattoing under the lesionInflammatory Bowel Disease with expected fibrosis (Crohn disease or ulcerative colitis)
- Colon localization < 15 cm of the anal margin.
- Polyp invading a diverticulum
- Pedunculated polyp
- Absence of lesion
Sites / Locations
- University Hospital, Limoges
- Jean Mermoz Hospital
- Edouard Herriot Hospital
- Nancy University Hospital
- Cochin Hospital
- Pontchaillou Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Endoscopic submucosal dissection (ESD)
Endoscopic Mucosal Resection (WF-piece meal EMR)
Arm Description
Outcomes
Primary Outcome Measures
Compare recurrence rate at follow-up colonoscopy
Compare between two groups
Secondary Outcome Measures
Proportion of R0 resection rate
Compare between two groups
Cumulative complications rate after treatment
Compare between two groups
Endoscopic curative resection rate without surgery
Compare between two groups
Quality of life over time
Compare between two groups at Month 1, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36
Cost-effectiveness ratio
Compare between two groups
Cost-utility ratio
Compare between two groups
Cumulative surgical referral rate
Compare between two groups
Compare the proportion of technical failure
Compare between two groups
Full Information
NCT ID
NCT03962868
First Posted
May 22, 2019
Last Updated
May 30, 2023
Sponsor
University Hospital, Limoges
1. Study Identification
Unique Protocol Identification Number
NCT03962868
Brief Title
Endoscopic Submucosal Dissection (ESD) Versus Endoscopic Mucosal Resection (EMR) for Large Non Pedunculated Colonic Adenomas: a Randomized Comparative Trial
Acronym
RESECT COLON
Official Title
Endoscopic Submucosal Dissection (ESD) Versus Endoscopic Mucosal Resection (EMR) for Large Non Pedunculated Colonic Adenomas: a Randomized Comparative Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 17, 2019 (Actual)
Primary Completion Date
September 28, 2021 (Actual)
Study Completion Date
April 28, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Limoges
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Initially developed in Japan for the treatment of endemic superficial gastric cancers, endoscopic submucosal dissection (ESD) allows resection of pre-neoplastic and neoplastic lesions of the digestive tract into a single fragment. It allows a perfect pathological analysis, and decreases the rate of recurrence of the adenoma to less than 2% However, this procedure, which is technically more challenging, is also more risky (perforation rate at 4% vs. 1% for WF-EMR) and longer. Submucosal dissection is also more expensive in terms of equipment, but this difference can be offset by the cost of the high number of iterative colonoscopies required in patients who have had endoscopic resection by WF-EMR.
Scientific debate is agitating the Western world1,2 and Japanese experts do not perform WF-EMR anymore, whereas no comparative prospective study has compared these two procedures.
We therefore propose to compare these two endoscopic resection strategies in terms of recurrence rate at 6 months and to estimate the differential cost-effectiveness and cost-utility ratios over a 36-month time horizon.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Polyp
Keywords
Colonic Polyp, large non pedunculated, colonic adenoma, Endoscopic submucosal dissection, Endoscopic Mucosal Resection
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
360 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Endoscopic submucosal dissection (ESD)
Arm Type
Experimental
Arm Title
Endoscopic Mucosal Resection (WF-piece meal EMR)
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Experimental procedure : ESD
Intervention Description
ESD is a new endoscopic resection procedure that allows en-bloc resection for large superficial colorectal neoplasms. It used dedicated devices and consists in a deep submucosal dissection under the lesion after surelevation thanks to submucosal fluid injection and mucosal incision all around the lesion. The en bloc resection allows a perfect pathological analysis and a very low risk of recurrence (<1.5%)
Intervention Type
Procedure
Intervention Name(s)
Comparison procedure: WF-piece meal EMR
Intervention Description
WF-piece meal EMR is an older endoscopic resection technique. After surelevation of the lesion thanks to fluid submucosal injection, the precancerous lesion is resected in several pieces using a polypectomy snare. At the end of the procedure when macroscopically visible adenoma has been totally resected a snare tip coagulation of the margin of the scar is performed to destroy potential non visible residual adenoma. This procedure is quicker, safer than ESD but result in more recurrent disease (from 10 to 30% for lesions larger than 25 mm).
Primary Outcome Measure Information:
Title
Compare recurrence rate at follow-up colonoscopy
Description
Compare between two groups
Time Frame
Month 6
Secondary Outcome Measure Information:
Title
Proportion of R0 resection rate
Description
Compare between two groups
Time Frame
Month 1
Title
Cumulative complications rate after treatment
Description
Compare between two groups
Time Frame
Month 1
Title
Endoscopic curative resection rate without surgery
Description
Compare between two groups
Time Frame
Month 36
Title
Quality of life over time
Description
Compare between two groups at Month 1, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36
Time Frame
Month 36
Title
Cost-effectiveness ratio
Description
Compare between two groups
Time Frame
Month 36
Title
Cost-utility ratio
Description
Compare between two groups
Time Frame
Month 36
Title
Cumulative surgical referral rate
Description
Compare between two groups
Time Frame
Month 36
Title
Compare the proportion of technical failure
Description
Compare between two groups
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient suffering from non-pedunculated polyp suspected larger than 25 mm in the colon
Colon localization beyond 15 cm of the anal margin.
Indication for endoscopic treatment
Patients aged ≥ 18 years old
Patients able to fill in questionnaires written in French
Exclusion Criteria:
Prior endoscopic resection attempt
Contra-indication to colonoscopy
Contra-indication to general anesthesia
Inability to stop antiplatelet agents and anti-coagulant according to the European Society of Gastro-Intestinal Endoscopy guidelines.
Recurrent adenoma: post-endoscopic or surgical resection
Pregnant or lactating women
Genetic polyposis (Familial Adenomatous Polyposis, Lynch Syndrome, Peutz-Jeghers Syndrome)
Inability to provide informed consent
Patient under legal protection and or deprived of liberty by judicial or administrative decision
Patient already participating in an interventional clinical research protocol
Patient who cannot be followed for the duration of the study
Non-pedunculated polyp ≤ 25 mm
More than one lesion > 25 mm that fulfilled the inclusion criteria
Suspicion of deep submucosal cancer by analysis of macroscopic appearance (Paris 0-III), vascular pattern and pit pattern (SANO IIIB, KUDO Vn)
Non granular pseudodepressed Laterally spreading tumors due to the high risk of nonvisible submucosal cancer
Polyp involving the appendice deeply (type 2 or 3 of classification of Toyonaga)
Polyp inside the ileo-caecal valvula
Tattoing under the lesionInflammatory Bowel Disease with expected fibrosis (Crohn disease or ulcerative colitis)
Colon localization < 15 cm of the anal margin.
Polyp invading a diverticulum
Pedunculated polyp
Absence of lesion
Facility Information:
Facility Name
University Hospital, Limoges
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Jean Mermoz Hospital
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
Edouard Herriot Hospital
City
Lyon
ZIP/Postal Code
69437
Country
France
Facility Name
Nancy University Hospital
City
Nancy
ZIP/Postal Code
54500
Country
France
Facility Name
Cochin Hospital
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Pontchaillou Hospital
City
Rennes
ZIP/Postal Code
35033
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Endoscopic Submucosal Dissection (ESD) Versus Endoscopic Mucosal Resection (EMR) for Large Non Pedunculated Colonic Adenomas: a Randomized Comparative Trial
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