Complete Closure After EMR for Colon Polyps

(Closure-RCT Trial)

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

Trial Summary

What is the purpose of this 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. 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.

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.

Is prophylactic defect closure after EMR for colon polyps safe?

Prophylactic closure of mucosal defects after removing large colon polyps can help prevent delayed bleeding, which is a common issue. However, closing large defects can be challenging, and while it may prevent bleeding, it does not always guarantee complete closure. The safety of this procedure is generally supported, especially in high-risk cases, but it requires careful consideration of the patient's condition and potential risks. ^{1 2 3 4 5}

How does prophylactic defect closure differ from other treatments for colon polyps after EMR?

Prophylactic defect closure involves using clips to close the mucosal defect after removing large colon polyps, which can help reduce the risk of delayed bleeding. This approach is unique because it specifically targets the prevention of bleeding complications, especially in larger or more difficult-to-reach polyps, compared to other treatments that may not address this risk as directly. ^{1 2 3 5 6}

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Factors associated with complete clip closure after endoscopic mucosal resection of large colorectal polyps. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Novel through-the-scope suture closure of colonic EMR defects (with video). [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Clipping prevents perforation in large, flat polyps. [2020]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Prophylactic Suturing Closure Is Recommended after Endoscopic Treatment of Colorectal Tumors in Patients with Antiplatelet/Anticoagulant Therapy. [2017]

5. United States pubmed.ncbi.nlm.nih.gov

Clip Closure After Resection of Large Colorectal Lesions With Substantial Risk of Bleeding. [2019]

6. Netherlands 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. [2022]