Colorectal CancerClosure-RCTNCT06807073
Complete Closure After Endoscopic Mucosal Resection of Large Non-Pedunculated Colorectal Polyps
A study testing Prophylactic defect closure and No prophylactic defect closure in people with Colorectal Cancer and Polyp of Colon, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
The goal of this clinical trial is to compare adverse even rates after EMR for large (≥20mm) flat colorectal polyps (so-called laterally spreading lesions, LSLs) when performing complete or no defect closure. It will also evaluate lesion recurrence after EMR for large colorectal LSLs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Polyp of Colon
- What is being tested?
- Prophylactic defect closure and No prophylactic defect closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 686 participants
- Where
- 1 siteCanada
- Study dates
- 27 Feb 2025to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- adult ≥18 years old
- patients undergoing EMR for a large (≥20mm) colorectal LSL
- patients providing written and informed consent for study participation.
Who cannot join
- inflammatory bowel disease;
- non-elective colonoscopy;
- poor general health (American Society of Anesthesiologists classification >III);
- coagulopathy or thrombocytopenia (international normalized ratio ≥1.5 or platelets <50 x 109/L);
- pedunculated polyps (Paris class Ip, Isp);
- overt signs of deep submucosal invasive cancer (JNET 3);
- appendiceal orifice or terminal ileum invasion;
- pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec
Samira Hanin, 514-890-8000 ext. 30916, samira.hanin.chum@ssss.gouv.qc.ca
Daniel von Renteln, MD
About this study
Official title: Complete Closure After Endoscopic Mucosal Resection of Large Non-Pedunculated Colorectal Polyps: A Randomized Controlled Trial
The goal of this clinical trial is to compare adverse even rates after EMR for large (≥20mm) flat colorectal polyps (so-called laterally spreading lesions, LSLs) when performing complete or no defect closure. It will also evaluate lesion recurrence after EMR for large colorectal LSLs.
The hypothesis is that performing complete defect closure following EMR of large colorectal LSLs will result in lower rates of adverse events compared to cases where no defect closure is performed.
Read more
For participants with planned EMR, endoscopists will perform EMRs as per standard of care and:
- prophylactic defect closure will either not be performed (control group), or will be performed (experimental group);
- then, patients will be called between 14 and 44 days after EMR to assess for possible adverse events, and electronic medical files will be verified for emergency room visits and healthcare received for an adverse event;
- finally, patients will undergo follow-up colonoscopy 6 months and 18 months after randomization.
Read the detailed description
This trial is an open-label, two-arm, parallel-group, multicenter, randomized controlled superiority trial. Patients undergoing EMR will be randomized in a 1:1 ratio and assigned to undergo no closure (control group) vs complete defect closure (experimental group).
Participants with planned EMR procedures will be approached by a research assistant before the EMR to request study participation. To mitigate loss to follow-up, patients will be questioned on their preferred contact method with multiple contact methods obtained to adequately reach patients. The importance of follow-up after EMR to detect and treat recurrence will also be highlighted both verbally and in the consent forms during initial patient contact.
Despite being experienced, all endoscopist participants will review dedicated teaching videos showing the standardized EMR approach. Videos demonstrating key technical details defect closure will also be circulated across sites to ensure a standardized approach for both procedures as described in the literature.
- Control group: EMR will be performed as per standard of care with submucosal injection and electrocautery resection of all visually visible polyp tissue using a snare. After performing EMR with thermal ablation, prophylactic defect closure will not be performed. Endoscopists can chose to close defects if there are significant concerns for risk of perforation or active perforation after EMR. When the endoscopist determines that the resection is complete, a tattoo will be placed 3 cm distal to the resected lesion to allow for better identification of the resection site in case of follow-up colonoscopy for delayed bleeding. If multiple large polyps are found and removed, the largest lesion (study polyp) will be marked with two tattoos 3 cm distal and 3 cm proximal to the lesion, to clearly identify the study polyp resection site.
- Experimental group: EMR will be performed as per standard of care with submucosal injection and electrocautery resection of all visually visible polyp tissue using a snare.
After performing EMR with thermal ablation, prophylactic defect closure will be performed. The choice of the number and types of closure devices used to achieve defect closure will be left to endoscopist discretion. If multiple large polyps are found and removed, the largest lesion (study polyp) will be marked with two tattoos 3 cm distal and 3 cm proximal to the lesion, to clearly identify the study polyp resection site. As per standard of care, endoscopists will take a photograph of the lesion before resection for documentation; a photograph of the EMR resection site will be taken before and after defect closure; a photograph of the defect will be taken if emergency colonoscopy is performed to treat delayed bleeding. When more than one lesion meeting inclusion criteria is present in a patient, all lesions 20mm or larger will be photographed next to an open snare to aid in size measurement.
- 6-month \& 18-month follow-up colonoscopies: To mitigate loss to follow-up, patients will be questioned on their preferred contact method with multiple contact methods obtained to adequately reach patients. The importance of follow-up after EMR to detect and treat recurrence will also be highlighted both verbally and in the consent forms during initial patient contact. Patients will be sent a reminder that they will soon receive an invitation to undergo follow-up through their preferred contact method. If patients do not undergo follow-up after invitation, a research assistant will contact patients by phone to answer any concerns they might have at that time.
At follow-up colonoscopies, endoscopists will identify the resection scar tangential to the tattoo placed at the initial EMR. The resection scars will be observed under white light and digital chromoendoscopy to assess for visual recurrence. For all patients, four random biopsies will be taken at the resection scar. If visual recurrence is present, the lesions will be resected using the method deemed most appropriate by the endoscopist at the time and pathologically evaluated for histologic recurrence.
- Conditions
- Colorectal Cancer, Polyp of Colon
- Being tested
- Prophylactic defect closure, No prophylactic defect closure
- Medical subject headings
- Colorectal Neoplasms, Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prophylactic defect closureProcedure or surgery
Endoscopists will use at least one new generation closure device to approximate the healthy mucosal surrounding the submucosal defect to ensure complete defect closure. Adequate apposition of the mucosal defect margins will be achieved when no visible submucosal areas >3 mm along the closure line are present.
No prophylactic defect closureProcedure or surgery
After performing EMR with thermal ablation, prophylactic defect closure will not be performed.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic Mucosal Resection (EMR) + prophylactic defect closure (defect closure) | Experimental | Prophylactic defect closure will be performed using at least one new generation closure device. |
| Endoscopic Mucosal Resection (EMR) | Active comparator | After performing EMR with thermal ablation, prophylactic defect closure will not be performed. Receives: Procedure: No prophylactic defect closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delayed bleeding
Defined as blood per rectum resulting in emergency room visit, unplanned hospitalization; endoscopic, radiologic, or surgical intervention.
Measured: 14 days
Delayed perforation
Defined as endoscopic or radiologic evidence of air or luminal contents outside the gastrointestinal tract
Measured: 14 days
Secondary outcomes (4)
Any delayed bleeding
Defined as blood per rectum after the procedure
Measured: 14 days
Clinically significant delayed bleeding in the proximal colon
Defined as proximal to the splenic flexure
Measured: 14 days
Clinically significant delayed bleeding in the distal colon
The distal colon is defined as splenic flexure and distal
Measured: 14 days
Lesion recurrence
Lesion recurrence at 6 months' follow-up defined by pathology-confirmed hyperplastic, serrated or adenomatous histology at the tattooed resection site
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start27 Feb 2025
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 686 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
- Sponsor type
- University, hospital or other
- Collaborators
- Dartmouth-Hitchcock Medical Center, Charles LeMoyne Hospital, London Health Sciences Centre, St. Paul's Hospital, Canada, University of Toronto, Froedtert Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06807073
- Sponsor's protocol ID
- 2025-12350
- Other IDs
- 2025
- Acronym
- Closure-RCT
- Status last verified
- Apr 2026
- First submitted
- 29 Jan 2025
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complete Closure After Endoscopic Mucosal Resection of Large Non-Pedunculated Colorectal Polyps: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06807073
- Acronym / sponsor ID
- Closure-RCT / 2025-12350
- Conditions
- Colorectal Cancer, Polyp of Colon
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 686 participants (estimated)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Collaborators
- Dartmouth-Hitchcock Medical Center, Charles LeMoyne Hospital, London Health Sciences Centre, St. Paul's Hospital, Canada, University of Toronto, Froedtert Hospital
- Study start
- 27 Feb 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 4 Feb 2025 (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.
The goal of this clinical trial is to compare adverse even rates after EMR for large (≥20mm) flat colorectal polyps (so-called laterally spreading lesions, LSLs) when performing complete or no defect closure. It will also evaluate lesion recurrence after EMR for large colorectal LSLs.
The hypothesis is that performing complete defect closure following EMR of large colorectal LSLs will result in lower rates of adverse events compared to cases where no defect closure is performed.
For participants with planned EMR, endoscopists will perform EMRs as per standard of care and:
- prophylactic defect closure will either not be performed (control group), or will be performed (experimental group);
- then, patients will be called between 14 and 44 days after EMR to assess for possible adverse events, and electronic medical files will be verified for emergency room visits and healthcare received for an adverse event;
- finally, patients will undergo follow-up colonoscopy 6 months and 18 months after randomization.
Detailed description
This trial is an open-label, two-arm, parallel-group, multicenter, randomized controlled superiority trial. Patients undergoing EMR will be randomized in a 1:1 ratio and assigned to undergo no closure (control group) vs complete defect closure (experimental group).
Participants with planned EMR procedures will be approached by a research assistant before the EMR to request study participation. To mitigate loss to follow-up, patients will be questioned on their preferred contact method with multiple contact methods obtained to adequately reach patients. The importance of follow-up after EMR to detect and treat recurrence will also be highlighted both verbally and in the consent forms during initial patient contact.
Despite being experienced, all endoscopist participants will review dedicated teaching videos showing the standardized EMR approach. Videos demonstrating key technical details defect closure will also be circulated across sites to ensure a standardized approach for both procedures as described in the literature.
- Control group: EMR will be performed as per standard of care with submucosal injection and electrocautery resection of all visually visible polyp tissue using a snare. After performing EMR with thermal ablation, prophylactic defect closure will not be performed. Endoscopists can chose to close defects if there are significant concerns for risk of perforation or active perforation after EMR. When the endoscopist determines that the resection is complete, a tattoo will be placed 3 cm distal to the resected lesion to allow for better identification of the resection site in case of follow-up colonoscopy for delayed bleeding. If multiple large polyps are found and removed, the largest lesion (study polyp) will be marked with two tattoos 3 cm distal and 3 cm proximal to the lesion, to clearly identify the study polyp resection site.
- Experimental group: EMR will be performed as per standard of care with submucosal injection and electrocautery resection of all visually visible polyp tissue using a snare.
After performing EMR with thermal ablation, prophylactic defect closure will be performed. The choice of the number and types of closure devices used to achieve defect closure will be left to endoscopist discretion. If multiple large polyps are found and removed, the largest lesion (study polyp) will be marked with two tattoos 3 cm distal and 3 cm proximal to the lesion, to clearly identify the study polyp resection site. As per standard of care, endoscopists will take a photograph of the lesion before resection for documentation; a photograph of the EMR resection site will be taken before and after defect closure; a photograph of the defect will be taken if emergency colonoscopy is performed to treat delayed bleeding. When more than one lesion meeting inclusion criteria is present in a patient, all lesions 20mm or larger will be photographed next to an open snare to aid in size measurement.
- 6-month \& 18-month follow-up colonoscopies: To mitigate loss to follow-up, patients will be questioned on their preferred contact method with multiple contact methods obtained to adequately reach patients. The importance of follow-up after EMR to detect and treat recurrence will also be highlighted both verbally and in the consent forms during initial patient contact. Patients will be sent a reminder that they will soon receive an invitation to undergo follow-up through their preferred contact method. If patients do not undergo follow-up after invitation, a research assistant will contact patients by phone to answer any concerns they might have at that time.
At follow-up colonoscopies, endoscopists will identify the resection scar tangential to the tattoo placed at the initial EMR. The resection scars will be observed under white light and digital chromoendoscopy to assess for visual recurrence. For all patients, four random biopsies will be taken at the resection scar. If visual recurrence is present, the lesions will be resected using the method deemed most appropriate by the endoscopist at the time and pathologically evaluated for histologic recurrence.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoscopic Mucosal Resection (EMR) + prophylactic defect closure (defect closure) | Experimental | –Prophylactic defect closure will be performed using at least one new generation closure device. |
| Endoscopic Mucosal Resection (EMR) | Active comparator | Procedure: No prophylactic defect closureAfter performing EMR with thermal ablation, prophylactic defect closure will not be performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adult ≥18 years old
- patients undergoing EMR for a large (≥20mm) colorectal LSL
- patients providing written and informed consent for study participation.
Key exclusion criteria (8 listed)
- inflammatory bowel disease;
- non-elective colonoscopy;
- poor general health (American Society of Anesthesiologists classification >III);
- coagulopathy or thrombocytopenia (international normalized ratio ≥1.5 or platelets <50 x 109/L);
- pedunculated polyps (Paris class Ip, Isp);
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 |
|---|---|---|
| Prophylactic defect closureEndoscopists will use at least one new generation closure device to approximate the healthy mucosal surrounding the submucosal defect to ensure complete defect closure. Adequate apposition of the mucosal defect margins will be achieved when no visible submucosal areas >3 mm along the closure line are present. | Procedure or surgery | – |
| No prophylactic defect closureAfter performing EMR with thermal ablation, prophylactic defect closure will not be performed. | Procedure or surgery | Endoscopic Mucosal Resection (EMR) |
Primary outcome
Delayed bleeding
Time frame: 14 days
Defined as blood per rectum resulting in emergency room visit, unplanned hospitalization; endoscopic, radiologic, or surgical intervention.
Delayed perforation
Time frame: 14 days
Defined as endoscopic or radiologic evidence of air or luminal contents outside the gastrointestinal tract
4 secondary outcomes
Any delayed bleeding
Time frame: 14 days
Clinically significant delayed bleeding in the proximal colon
Time frame: 14 days
Clinically significant delayed bleeding in the distal colon
Time frame: 14 days
Lesion recurrence
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures and appendices).
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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.
Centre Hospitalier de l'Université de Montréal
Montreal, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prophylactic defect closure and No prophylactic defect closure in people with Colorectal Cancer and Polyp of Colon, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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 3 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delayed bleeding (time frame: 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Sep 2026.