Efficacy, Safety and Recurrence After Cold-EMR Plus APC for Large Colonic Lesions

Not yet recruiting

• Conditions: Colonic Disease

• Registration Number: NCT06435377
• Lead Sponsor: Istituto Clinico Humanitas

Brief Summary

This prospective observational study aims to evaluate the efficacy, safety and recurrence of cold-snaring for large colonic lesions combined with argon plasma coagulation of the resection bed.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-24
• Study First Submitted QC: 2024-05-24
• Last Update Submitted: 2024-05-24
• Study First Posted: 2024-05-30
• Last Update Posted: 2024-05-30
• Study Start: 2024-07-01
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• All patients aged ≧ 18 years undergoing colonoscopy for any indication (screening, anemia, surveillance, or scheduled to undergo endoscopic mucosal resection)
• Lesions of 20 mm and larger.
• All colonic lesions removed using COLD-EMR technique, presenting both adenomatous (Kudo IIIL/IIIS pit pattern)
• Patients who were able to provide written informed consent

Exclusion Criteria

• Suspected lesions for submucosal invasion (e.g., Kudo V or Paris 0-IIa-IIc with non-granular surface)
• Lesions with a wide Paris 0-Is component (>10mm) that could increase the risk of submucosal invasion and could limit the mechanical cutting of the snare
• Pedunculated polyps
• Active/quiescent colitis
• Rectal lesions
• Residual or recurrent adenoma after endoscopic mucosal resection

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Residual	1 day	Evaluation of residual in the biopsy of the defect after the cold-EMR. The specimen will be evaluated independently from the polyp sample.
Recurrence	1 year	The recurrence rate of adenomas at the site of any qualifying, previously resected lesions is measured after 3-6 and 12 months.

Secondary Outcome Measures

Name	Time	Method
perforation	1 day	Rate of perforation and delayed perforation
Efficacy of procedure	1 day	Complete resection of polyp
Rate of delayed bleeding of the patient	1 day	Delayed-bleeding, defined was defined as clinical evidence of bleeding (hematemesis, hematochezia or melena or a decrease of hemoglobin concentration \> 2g/dL, which required transfusion or endoscopic reintervention with hemostasis within 30 days of hospital discharge)
Time	1 day	Average time of procedure and polyp resection time
Rate of post-polipectomy syndrome	1 day	The post-polipectomy syndrome is defined by the presence of fever or abdominal pain

Trial Locations

Locations (1)

Endoscopy Unit, Gastroenterology Department, Humanitas Research Hospital; 🇮🇹 Rozzano, Milano, Italy