Recurrences After Standard EMR vs Plus Thermal Ablation EMR

Not Applicable

Recruiting

• Conditions: Recurrence, Local Neoplasm; Polyps of Colon
• Interventions: Procedure: Snare tip soft coagulation

• Registration Number: NCT05121805
• Lead Sponsor: Radboud University Medical Center

Brief Summary

The primary objective of this trial is to investigate whether thermal ablation EMR with soft tip snare coagulation (STSC) reduces the recurrence rate of lateral spreading or sessile polyps ≥20mm compared to standard EMR.

Detailed Description

Rationale:

Lowering the EMR recurrence rate will potentially lead to fewer colonoscopies resulting in less additional costs, less compliance burdens and less exposure to possible procedure related risks.

Objective:

To investigate whether thermal ablation EMR with snare tip soft coagulation (STSC) reduces the recurrence rate of lateral spreading or sessile polyps ≥20mm compared to standard EMR.

Study design:

This study entails a patient-blinded multicenter prospective randomized controlled trial that will be conducted between January 2022 and May 2025 in 1 academic and 7 non-academic hospitals in The Netherlands and it will take place in the outpatient clinics of the participating centers.

Study population:

All patients aged ≥ 18 years with proven colorectal sessile of lateral spreading polyps (Paris classification 0-IIa/b/c, Is) with a diameter of ≥ 20mm requiring piecemeal resection with EMR are eligible for inclusion.

Intervention:

Snare tip soft coagulation of the entire EMR margin is a technique for the removal of potential residual adenoma.

Main study endpoint:

Polyp recurrence after 6 months follow up. Recurrence is evaluated histologically and endoscopically with biopsies taken during follow up colonoscopy.

Study Timeline

• Study First Submitted: 2021-11-04
• Study First Submitted QC: 2021-11-04
• Study First Posted: 2021-11-16
• Study Start: 2022-03-17
• Status Verified: 2023-03
• Last Update Submitted: 2023-12-19
• Last Update Posted: 2023-12-26
• Primary Completion: 2024-04
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 306

Inclusion Criteria

• Proven colorectal sessile or lateral spreading polyps with a diameter of ≥ 20mm requiring piecemeal resection with EMR.

Exclusion Criteria

• Previously attempted intervention
• Polyps with any signs of invasive malignancy
• Presence or suspicion of inflammatory bowel disease
• En bloc resection
• Incomplete resection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EMR plus snare tip soft coagulation	Snare tip soft coagulation	Post procedural prophylactic coagulation of the entire margin of the resection site creating a 2-3mm rim.

Primary Outcome Measures

Name	Time	Method
Recurrence	6 months	Adenoma recurrence at resection site

Trial Locations

Locations (1)

Radboudumc; 🇳🇱 Nijmegen, Gelderland, Netherlands