Adjuvant Thermal Ablation for Colon Polyps

(COSA-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

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: 4

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if adding heat treatment (adjuvant thermal ablation) during the removal of large, flat colon polyps can reduce the likelihood of recurrence. After removing the polyps using a standard method, some participants will receive this additional heat treatment, while others will not, allowing for a comparison of results. The trial targets adults planning to undergo a standard procedure to remove large colon polyps (20 mm or larger). Participants will have follow-up checks to assess the treatment's effectiveness and any side effects. This trial suits those scheduled for non-emergency colon polyp removal. As an unphased trial, it offers a unique opportunity to contribute to medical knowledge and potentially benefit from an innovative treatment approach.

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 adjuvant thermal ablation is safe for colon polyp treatment?

Research shows that heat treatment after removing large colorectal polyps is generally safe. Studies have found that this method helps prevent polyps from returning during follow-up checks.

Potential risks include bleeding, a tear in the colon, pain, or postpolypectomy syndrome, which involves symptoms like belly pain and fever after polyp removal. However, these risks remain mostly theoretical, and studies have not found them to be common.

Overall, evidence suggests that while some risks exist, heat treatment is usually well-tolerated and effective in reducing the chance of polyps returning. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatment for colon polyps, which typically involves endoscopic mucosal resection (EMR) alone, the new approach adds adjuvant thermal ablation to the mix. Researchers are excited about this method because it applies heat to the base and margins of the resection site right after the EMR. This could potentially reduce the risk of polyp regrowth by targeting any residual abnormal tissue that might be left behind. By combining EMR with thermal ablation, this technique aims to improve the thoroughness and effectiveness of polyp removal, offering a more comprehensive treatment option.

What evidence suggests that adjuvant thermal ablation is effective for reducing lesion recurrence in large colorectal polyps?

Research has shown that using heat treatment after removing polyps with a scope can greatly reduce the chances of polyps returning. In this trial, one group will receive endoscopic mucosal resection (EMR) with adjuvant thermal ablation, where heat is applied to the base and outside margins of the resection site. Another group will receive EMR without the adjuvant thermal ablation. One study found that this heat treatment lowered the recurrence of certain types of polyps at the first follow-up check. Another study supported this, showing that applying heat to the edges of the removed area reduced the return of growths without causing more side effects. Additionally, reports indicated low rates of complications like tears, pain, and fever after polyp removal. These findings suggest that heat treatment is a promising way to improve outcomes after removing large polyps in the colon. ^{1 2 3 5 6}

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 non-thermal endoscopic mucosal resection and must not have conditions that exclude them from the study.

Inclusion Criteria

Providing written and informed consent for study participation

I am 18 years old or older.

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

Exclusion Criteria

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

Coagulopathy or thrombocytopenia (international normalized ratio ≥1.5 or platelets <50*10^9/L)

Presence of bulky lesions (granular mixed with ≥10mm module)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo non-thermal endoscopic mucosal resection (EMR) with or without adjuvant thermal ablation

1 day

1 visit (in-person)

Adverse Event Monitoring

Participants are contacted 14-44 days post-EMR to ascertain the occurrence of adverse events

4 weeks

1 contact (virtual)

First Follow-up

Participants undergo a follow-up colonoscopy to assess lesion recurrence

6 months

1 visit (in-person)

Second Follow-up

Participants undergo a second and final colonoscopy to assess lesion recurrence and complete study follow-up

18 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Adjuvant thermal ablation

Trial Overview The study tests if using adjuvant thermal ablation after removing large colorectal polyps can reduce their recurrence. Patients are randomly assigned to either receive additional heat treatment at the removal site or no extra treatment, with follow-ups at 6 and 18 months.

How Is the Trial Designed?

Group I: Endoscopic mucosal resection (EMR) + adjuvant thermal ablation Experimental Treatment 1 Intervention

Adjuvant thermal ablation will be applied to the base and outside margins of the resection site after non-thermal EMR.

Group II: Endoscopic mucosal resection (EMR) Active Control 1 Intervention

After non-thermal EMR, no adjuvant thermal ablation will be performed.

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials

389

Recruited

143,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9576327/

Post-EMR for colorectal polyps, thermal ablation of defects ... Conclusions Thermal ablation of post-EMR defects significantly reduces adenoma recurrence at first surveillance colonoscopy. Introduction.

2. gastrojournal.org gastrojournal.org/article/S0016-5085(21)00571-0/fulltext

Outcomes of Thermal Ablation of the Mucosal Defect ... Thermal ablation of the defect margin after endoscopic mucosal resection (EMR-T) has shown efficacy in a randomized trial in reducing adenoma ...

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

Safety and efficacy of margin and base ablation after ... Postprocedural perforation occurred in 0.6% (95% CI, 0.0-3.1), and postpolypectomy syndrome occurred in 1.7% (95% CI, 0.3-4.8). At SC1, ...

4. mdpi.com mdpi.com/2077-0383/13/5/1298

Efficacy and Safety of Thermal Ablation after Endoscopic ... In conclusion, we demonstrated reduced recurrence of lesions and no increase in adverse events with the use of thermal ablation compared to ...

5. link.springer.com link.springer.com/article/10.1007/s12664-025-01838-9

Updates in the endoscopic management of colorectal polyps Thermal Ablation of mucosal defect margins reduces adenoma recurrence after colonic endoscopic mucosal resection. ... Outcomes of thermal ablation ...

6. gut.bmj.com gut.bmj.com/content/74/1/67.full.pdf

pedunculated colonic polyps on long- term recurrence colonic polyps after endoscopic mucosal resection with adjuvant margin thermal ablation are unknown. ... Outcomes of Thermal Ablation of ...