Colonic PolypRESECT COLONNCT03962868
Endoscopic Submucosal Dissection (ESD) Versus Endoscopic Mucosal Resection (EMR) for Large Non Pedunculated Colonic Adenomas: a Randomized Comparative Trial
A study testing Experimental procedure : ESD and Comparison procedure: WF-piece meal EMR in people with Colonic Polyp, run by University Hospital, Limoges at 6 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonic Polyp
- What is being tested?
- Experimental procedure : ESD and Comparison procedure: WF-piece meal EMR
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 6 sitesFrance
- Study dates
- 17 Sep 2019to 19 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 23Show fewer
- 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 lesion
- Inflammatory 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
University Hospital, Limoges
Limoges, France, 87042
Jean Mermoz Hospital
Lyon, France, 69008
Edouard Herriot Hospital
Lyon, 69437
Nancy University Hospital
Nancy, 54500
Cochin Hospital
Paris, 75014
Pontchaillou Hospital
Rennes, 35033
About this study
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.
- Conditions
- Colonic Polyp
- Being tested
- Experimental procedure : ESD, Comparison procedure: WF-piece meal EMR
- Keywords
- Colonic Polyp, large non pedunculated, colonic adenoma, Endoscopic submucosal dissection, Endoscopic Mucosal Resection
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental procedure : ESDProcedure or surgery
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%)
Comparison procedure: WF-piece meal EMRProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic submucosal dissection (ESD) | Experimental | Not described Receives: Procedure: Experimental procedure : ESD |
| Endoscopic Mucosal Resection (WF-piece meal EMR) | Active comparator | Not described Receives: Procedure: Comparison procedure: WF-piece meal EMR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare recurrence rate at follow-up colonoscopy
Compare between two groups
Measured: Month 6
Secondary outcomes (8)
Proportion of R0 resection rate
Compare between two groups
Measured: Month 1
Cumulative complications rate after treatment
Compare between two groups
Measured: Month 1
Endoscopic curative resection rate without surgery
Compare between two groups
Measured: Month 36
Quality of life over time
Compare between two groups at Month 1, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36
Measured: Month 36
Cost-effectiveness ratio
Compare between two groups
Measured: Month 36
Cost-utility ratio
Compare between two groups
Measured: Month 36
Cumulative surgical referral rate
Compare between two groups
Measured: Month 36
Compare the proportion of technical failure
Compare between two groups
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2019
- Study start17 Sep 2019
- Primary completion28 Sep 2021
- Study completion19 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colonic PolypStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03962868
- Sponsor's protocol ID
- 87RI18_0002 (RESECT COLON)
- Acronym
- RESECT COLON
- Status last verified
- Jan 2026
- First submitted
- 22 May 2019
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jacques J, Schaefer M, Wallenhorst T, Rosch T, Lepilliez V, Chaussade S, Rivory J, Legros R, Chevaux JB, Leblanc S, Rostain F, Barret M, Albouys J, Belle A, Labrunie A, Preux PM, Lepetit H, Dahan M, Ponchon T, Crepin S, Marais L, Magne J, Pioche M. Endoscopic En Bloc Versus Piecemeal Resection of Large Nonpedunculated Colonic Adenomas : A Randomized Comparative Trial. Ann Intern Med. 2024 Jan;177(1):29-38. doi: 10.7326/M23-1812. Epub 2023 Dec 12.
PubMed 38079634
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Submucosal Dissection (ESD) Versus Endoscopic Mucosal Resection (EMR) for Large Non Pedunculated Colonic Adenomas: a Randomized Comparative Trial
- ClinicalTrials.gov ID
- NCT03962868
- Acronym / sponsor ID
- RESECT COLON / 87RI18_0002 (RESECT COLON)
- Conditions
- Colonic Polyp
- Keywords
- Colonic Polyp, large non pedunculated, colonic adenoma, Endoscopic submucosal dissection, Endoscopic Mucosal Resection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- 17 Sep 2019 (actual)
- Primary completion
- 28 Sep 2021 (actual)
- Study completion
- 19 Mar 2025 (actual)
- First posted
- 24 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoscopic submucosal dissection (ESD) | Experimental | Procedure: Experimental procedure : ESD |
| Endoscopic Mucosal Resection (WF-piece meal EMR) | Active comparator | Procedure: Comparison procedure: WF-piece meal EMR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental procedure : ESDESD 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%) | Procedure or surgery | Endoscopic submucosal dissection (ESD) |
| Comparison procedure: WF-piece meal EMRWF-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). | Procedure or surgery | Endoscopic Mucosal Resection (WF-piece meal EMR) |
Primary outcome
Compare recurrence rate at follow-up colonoscopy
Time frame: Month 6
Compare between two groups
8 secondary outcomes
Proportion of R0 resection rate
Time frame: Month 1
Cumulative complications rate after treatment
Time frame: Month 1
Endoscopic curative resection rate without surgery
Time frame: Month 36
Quality of life over time
Time frame: Month 36
Cost-effectiveness ratio
Time frame: Month 36
Cost-utility ratio
Time frame: Month 36
Cumulative surgical referral rate
Time frame: Month 36
Compare the proportion of technical failure
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Derived from this study: PubMed 38079634Jacques J, Schaefer M, Wallenhorst T, Rosch T, Lepilliez V, Chaussade S, Rivory J, Legros R, Chevaux JB, Leblanc S, Rostain F, Barret M, Albouys J, Belle A, Labrunie A, Preux PM, Lepetit H, Dahan M, Ponchon T, Crepin S, Marais L, Magne J, Pioche M. Endoscopic En Bloc Versus Piecemeal Resection of Large Nonpedunculated Colonic Adenomas : A Randomized Comparative Trial. Ann Intern Med. 2024 Jan;177(1):29-38. doi: 10.7326/M23-1812. Epub 2023 Dec 12.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental procedure : ESD and Comparison procedure: WF-piece meal EMR in people with Colonic Polyp, run by University Hospital, Limoges at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare recurrence rate at follow-up colonoscopy (time frame: Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03962868, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026; AzTrials last refreshed its copy on 31 Oct 2026.