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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Colonic Disease
• Intervention / Treatment: Procedure: Procedure: Cold EMR + APC

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

Study Locations

• Italy
  • Milano
    • Rozzano, Milano, Italy, 20089
      • Endoscopy Unit, Gastroenterology Department, Humanitas Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All subjects will be evaluated for post-procedural pain (using a VAS scale) and need for pain-killers. As part of the standard care, the patient will receive a 30-day post procedure follow-up phone call or an ambulatory evaluation will be arranged 30-days after the endoscopic procedure, to discuss the histologic results and schedule a standard follow-up colonoscopy procedure after the initial procedure. The investigators will measure the post procedural pain in the first four weeks after treatment, the need for pain-killers and, should these occur, the adverse events (included fever, hematochezia, need for hospital admission). The rate of recurrence will be calculated by endoscopic visualization of the EMR site at the follow-up (T1:3-6 months; T2 11-13Months) using endoscopic magnification and electronic chromoendoscopy.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of procedure	Complete resection of polyp	1 day
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
Rate of post-polipectomy syndrome	The post-polipectomy syndrome is defined by the presence of fever or abdominal pain	1 day
perforation	Rate of perforation and delayed perforation	1 day
Time	Average time of procedure and polyp resection time	1 day

Collaborators and Investigators

• Sponsor: Istituto Clinico Humanitas

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: May 24, 2024
• First Submitted That Met QC Criteria: May 24, 2024
• First Posted (Actual): May 30, 2024

Study Record Updates

• Last Update Posted (Actual): May 30, 2024
• Last Update Submitted That Met QC Criteria: May 24, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Colonic Diseases
• Other Study ID Numbers: Cold-EMR plus APC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No