Complete Closure After EMR for Colon Polyps

(Closure-RCT Trial)

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Disqualifiers: Inflammatory bowel disease, Poor health, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: During procedure

686 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if closing the area after removing large flat colon polyps reduces complications compared to leaving it open. Participants will have their polyps removed, with some receiving prophylactic defect closure (a preventive measure to close the area) and others not. Researchers will monitor for side effects and observe if the polyps return over time. Individuals with large flat colon polyps scheduled for removal may be suitable candidates for this study. As an unphased trial, this study offers participants the chance to contribute to important research that could enhance future treatment options.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this protocol is safe for patients undergoing EMR for large colorectal polyps?

Research shows that closing the area where a colon polyp is removed can make the procedure safer. Studies have found that using a closure method reduces the risk of issues like delayed bleeding or a tear in the colon wall. For instance, one study found that using clips to close the area after removing a polyp significantly reduced bleeding. Another report noted that closure methods were successful in about 90% of cases, further lowering the chance of bleeding.

If the area is not closed after polyp removal, there is a slightly higher risk of complications. However, severe bleeding remains rare, occurring in only a small percentage of cases. Overall, evidence suggests that closing the area is generally well-tolerated and can help prevent some problems after polyp removal. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the effectiveness of prophylactic defect closure after Endoscopic Mucosal Resection (EMR) for colon polyps. Unlike traditional EMR, which often leaves the resection site open, this approach uses a new generation closure device to potentially prevent complications like bleeding or perforation. This technique could enhance patient safety and recovery time, offering a significant improvement over the current standard of care, which typically involves monitoring and addressing complications after they occur.

What evidence suggests that prophylactic defect closure is effective for reducing adverse events after EMR for large colorectal polyps?

This trial will compare two approaches following Endoscopic Mucosal Resection (EMR) for colon polyps: prophylactic defect closure and no prophylactic defect closure. Research has shown that closing the opening left after polyp removal during EMR can lower the risk of bleeding. One study found that closing this opening successfully reduced the chance of delayed bleeding in about 90% of cases. However, another study found that closing the opening did not significantly reduce bleeding for certain types of polyps. Overall, evidence suggests that closing the opening may help reduce complications like bleeding after EMR for large polyps. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with large, flat colorectal polyps (≥20mm), also known as laterally spreading lesions. Participants should be scheduled for an endoscopic mucosal resection (EMR) and willing to follow up after the procedure. Specific inclusion and exclusion criteria details are not provided.

Inclusion Criteria

Patients providing written and informed consent for study participation

I am having a procedure to remove a large growth in my colon.

Exclusion Criteria

My cancer has spread to the beginning of my large intestine or the end of my small intestine.

Poor general health (American Society of Anesthesiologists classification >III)

My cancer shows clear signs of deep growth into the layers of my gut.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Endoscopic Mucosal Resection (EMR) with or without prophylactic defect closure

During procedure

1 visit (in-person)

Initial Follow-up

Participants are monitored for adverse events and emergency room visits between 14 and 44 days after EMR

4 weeks

1 visit (virtual or phone call)

6-month Follow-up

Participants undergo follow-up colonoscopy to assess for lesion recurrence

6 months

1 visit (in-person)

18-month Follow-up

Participants undergo follow-up colonoscopy to assess for lesion recurrence and histologic evaluation

18 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• No prophylactic defect closure
• Prophylactic defect closure

Trial Overview The study compares two approaches after EMR: one group will have the site where the polyp was removed closed up as a precaution (experimental group), while the other won't have any closure (control group). The aim is to see if closing the defect reduces complications.

How Is the Trial Designed?

Group I: Endoscopic Mucosal Resection (EMR) + prophylactic defect closure (defect closure) Experimental Treatment 1 Intervention

Prophylactic defect closure will be performed using at least one new generation closure device.

Group II: Endoscopic Mucosal Resection (EMR) Active Control 1 Intervention

After performing EMR with thermal ablation, prophylactic defect closure will not be performed.

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials

389

Recruited

143,000+

Published Research Related to This Trial

In a study involving 94 patients who underwent endoscopic mucosal resection (EMR) of large colon polyps, the novel through-the-scope suturing (TTSS) device successfully closed all defects, demonstrating its effectiveness for large lesions.

The rate of delayed bleeding after using TTSS for defect closure was low at 3.2%, indicating that this method may significantly reduce post-EMR complications, although further studies are needed to confirm these results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel through-the-scope suture closure of colonic EMR defects (with video). Bi, D., Zhang, LY., Alqaisieh, M., et al.[2023]

Prophylactic clipping of mucosal defects after removing large, flat, right-sided polyps during endoscopic procedures significantly reduced the incidence of perforations from 4.2% to 0%, based on a study involving 151 polypectomies.

The study, which included data from 2,464 colonoscopies, demonstrated that clipping did not lead to any post-polypectomy hemorrhages, indicating a safe approach to preventing complications during polypectomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clipping prevents perforation in large, flat polyps. Luba, D., Raphael, M., Zimmerman, D., et al.[2020]

In a study of 458 patients undergoing endoscopic mucosal resection (EMR) of large colorectal polyps, complete closure of the mucosal defect using prophylactic clips was achieved in 68.4% of cases, indicating a significant risk of incomplete closure and potential for delayed bleeding.

Factors that improved the likelihood of complete clip closure included smaller polyp size, good access during the procedure, complete submucosal lifting, en bloc resection, and the presence of serrated histology, suggesting that while some factors can be controlled, many are inherent to the polyp characteristics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors associated with complete clip closure after endoscopic mucosal resection of large colorectal polyps. Ortiz, O., Rex, DK., Grimm, IS., et al.[2022]

In a randomized trial involving 235 patients with large nonpedunculated colorectal lesions, complete closure of mucosal defects using clips after endoscopic mucosal resection (EMR) significantly reduced the incidence of delayed bleeding from 12.1% in the control group to 5% in the clip group.

Successful prevention of delayed bleeding was only achieved when complete closure was accomplished, highlighting the importance of effective clip application in high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clip Closure After Resection of Large Colorectal Lesions With Substantial Risk of Bleeding. Albéniz, E., Álvarez, MA., Espinós, JC., et al.[2019]

Prophylactic closure of mucosal defects after endoscopic resection can effectively prevent postoperative bleeding in colorectal lesions, but is challenging for large defects using conventional clips.

The use of prophylactic closure should be reserved for high-risk patients, particularly those on antithrombotic or antiplatelet medications, due to the associated costs and time requirements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prophylactic Suturing Closure Is Recommended after Endoscopic Treatment of Colorectal Tumors in Patients with Antiplatelet/Anticoagulant Therapy. Sakurai, T., Adachi, T., Kono, M., et al.[2017]

In a randomized controlled trial involving 231 patients undergoing endoscopic mucosal resection (EMR) of large non-pedunculated colorectal polyps, prophylactic clip closure significantly reduced the incidence of clinically significant post-EMR bleeding in the right colon, with a reduction from 10.6% in the control group to 3.4% in the clip group.

The study found no significant differences in adverse events between the clip and control groups, indicating that the use of prophylactic clips is safe and does not increase the risk of complications such as perforation or pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of prophylactic endoscopic clip placement on clinically significant post-endoscopic mucosal resection bleeding in the right colon: a single-centre, randomised controlled trial. Gupta, S., Sidhu, M., Shahidi, N., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8962491/

Prophylactic clip closure for mucosal defects is associated ... Mucosal defect closure using endoscopic clips after endoscopic resection is expected to reduce the rate of delayed bleeding. Several large retrospective studies ...

2. gi.org gi.org/journals-publications/ebgi/abuheija_oct2025/

Does prophylactic clipping prevent delayed bleeding after ... Prophylactic clipping did not reduce delayed bleeding following EMR of large (≥20 mm) proximal nonpedunculated polyps in this pragmatic, ...

3. gut.bmj.com gut.bmj.com/content/74/11/1814

a multicentre randomised controlled trial (EPOC trial) Conclusions Prophylactic clip closure, successfully achieved in approximately 90% of cases, reduced the delayed bleeding rate after resection of colorectal ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0016510725016062

Prophylactic clipping versus no clipping after endoscopic ... PC is cost-saving for large (≥20 mm) proximal colonic polyps and is cost-effective for very large (≥40 mm) polyps regardless of their anatomical ...

5. link.springer.com link.springer.com/article/10.1007/s10620-025-09518-6

Effect of Prophylactic Colon ESD (Endoscopic Submucosal ... 560 patients underwent colon ESD and 364 (71.8%) patients had complete defect closure. Closed group had a significantly lower rate of delayed ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11492945/

Association between prophylactic closure of mucosal ... Prophylactic closure of mucosal defects is beneficial in reducing the incidence of delayed bleeding and delayed perforation after endoscopic resection.

7. sciencedirect.com sciencedirect.com/science/article/pii/S0016510725017225

Safety and efficacy of margin and base ablation after ... Severe postendoscopic bleeding occurred in 2.2% (95% CI, 0.6-5.6), all in proximal polyps that were not clipped. Postprocedural perforation ...

8. giejournal.org giejournal.org/issue/S0016-5107(25)X0005-5?pageStart=9

Published in issue: May 2025 OUTCOMES OF PROPHYLACTIC CLOSURE FOR COLONIC ... OUTCOMES OF UNDERWATER ENDOSCOPIC MUCOSAL RESECTION FOR COLORECTAL POLYPS ≥40 MM IN SIZE: A ...