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

Colonic Disease Clinical Trial

— EMR+APC  

Official title:

Prospective Observational Study APC AND BIOPSY POST COLD-EMR IN COLONIC LESIONS

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06435377
• Other study ID #: Cold-EMR plus APC
• Status: Not yet recruiting
• Start date: July 1, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: May 2024
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colonic Disease
• Colonic Diseases

Intervention

Procedure:
• Procedure: Cold EMR + APC
Initial submucosal injection of saline solution and methylene blue, followed by 'piece-meal' resection using a dedicated cold snare Biopsy of the resection bed Ablation of the defect using argon plasma coagulation (APC).

Locations

Country	Name	City	State
Italy	Endoscopy Unit, Gastroenterology Department, Humanitas Research Hospital	Rozzano	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Residual	Evaluation of residual in the biopsy of the defect after the cold-EMR. The specimen will be evaluated independently from the polyp sample.	1 day
Primary	Recurrence	The recurrence rate of adenomas at the site of any qualifying, previously resected lesions is measured after 3-6 and 12 months.	1 year
Secondary	Efficacy of procedure	Complete resection of polyp	1 day
Secondary	Rate of delayed bleeding of the patient	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)	1 day
Secondary	Rate of post-polipectomy syndrome	The post-polipectomy syndrome is defined by the presence of fever or abdominal pain	1 day
Secondary	perforation	Rate of perforation and delayed perforation	1 day
Secondary	Time	Average time of procedure and polyp resection time	1 day