Cold versus hot loop removal of medium benign colon polyps
Official title: The First Prospective Randomized Trial Comparing Cold and Hot Loop Resection for Removal of Medium-sized Benign Colon Tumors in Moscow, Russia.
Run by Pirogov Russian National Research Medical University · NCT07041255 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 100 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Pirogov Russian National Research Medical University Academic / other |
| Locations | 1 site (Moscow) |
| Status | Recruiting |
| Started | November 25, 2023 |
| Main results expected | October 10, 2025 |
| Study ends | September 30, 2026 |
| Registry record updated | June 27, 2025 |
| Trial ID | NCT07041255 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
Evgeny Gorbachev
Moscow, Russia Recruiting
Study contacts
- Study coordinator: Evgeny Fedorov
- Email: efedo@mail.ru
- Phone: +74999369980
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.