Cold versus hot loop removal of medium benign colon polyps
The First Prospective Randomized Trial Comparing Cold and Hot Loop Resection for Removal of Medium-sized Benign Colon Tumors in Moscow, Russia.
This will test whether removing medium-sized (10–14 mm) noncancerous colon polyps with a cold loop or a hot loop is safer and removes the polyp more completely.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Pirogov Russian National Research Medical University Academic / other |
| Locations | 1 site (Moscow) |
| Trial ID | NCT07041255 on ClinicalTrials.gov |
What this trial studies
This is a prospective, randomized, controlled, single-center trial enrolling at least 200 adults with a single non-invasive broad-based colon epithelial lesion measuring 10–14 mm. Participants are randomized to cold endoscopic mucosal resection (cold EMR) or hot EMR, with procedures guided by high-resolution colonoscopy using white and narrow spectrum light with magnification. Key outcomes are completeness of resection (en bloc vs piecemeal; R0 vs R1), depth of resection, immediate and delayed complications (bleeding, perforation, postcoagulation syndrome), and histologic correlation of preoperative endoscopic predictions. Short-term and long-term follow-up will compare recurrence and complication rates between the two techniques.
Who should consider this trial
Good fit: Adults (≥18 years) with a single benign, non-invasive broad-based colon epithelial lesion of type Is or II measuring 10–14 mm who can undergo colonoscopy and provide informed consent are ideal candidates.
Not a fit: Patients with suspected severe dysplasia or invasive cancer, recurrent lesions, inflammatory bowel disease, those on haemodialysis or with uncorrectable coagulopathy, or those unable to undergo colonoscopy are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the results could identify a technique that achieves more complete removal with fewer complications for medium-sized benign colon polyps.
How similar studies have performed: Prior studies have shown cold snare techniques work well for diminutive and small polyps, but randomized data specifically comparing cold versus hot EMR for 10–14 mm broad-based lesions are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * A patient with one benign non-invasive epithelial formation of the colon of type Is and II, measuring 10-14 mm * Age ≥ 18 years. * Signed informed voluntary consent for colonoscopy and removal of formations using the methods under study. Exclusion Criteria: * Reasonable suspicion of severe dysplasia/cancer, including with submucosal invasion based on the results of preoperative assessment (NICE - 3; JNET - 2b and 3; Kudo - Vi and Vn). -. Colonic lesions less than 10 mm * Recurrent lesion. * Presence of widespread malignant tumour in any part of the colon.- Use of other methods of endoscopic removal of the lesion. * IBD. * Patient on haemodialysis * Uncorrectable coagulopathy (INR\> 1.5). * Refusal to participate in the study. * General contraindications to endoscopic examination.
Where this trial is running
Moscow
- Evgeny Gorbachev — Moscow, Russia (Recruiting)
Study contacts
- Study coordinator: Evgeny Fedorov
- Email: efedo@mail.ru
- Phone: +74999369980
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.