Recurrences After Standard EMR vs Plus Thermal Ablation EMR

Study Overview
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Brief Summary
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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
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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.

Official Title
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Recurrences After Standard EMR vs Plus Thermal Ablation EMR of Advanced Sessile and Lateral Spreading Colorectal Adenoma

Conditions
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Polyps of Colon, Recurrence, Local Neoplasm

Intervention / Treatment
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* Procedure: Snare tip soft coagulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EMR plus snare tip soft coagulation<br>Post procedural prophylactic coagulation of the entire margin of the resection site creating a 2-3mm rim. | Procedure: Snare tip soft coagulation<br>* Thermal ablation of the entire resection margin<br>|
| No Intervention: Standard EMR<br>No prophylactic coagulation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence | Adenoma recurrence at resection site | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Snare tip soft coagulation, EMR