Recurrences After Standard EMR vs Plus Thermal Ablation EMR (RESPECT)

Radboud University Medical Center

Status: Enrolling

Conditions: Recurrence, Local Neoplasm; Polyps of Colon

Treatments: Procedure: Snare tip soft coagulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05121805

NL7463209120

Details and patient eligibility

About

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.

Full 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.

Enrollment: 306 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

306 participants in 2 patient groups

EMR plus snare tip soft coagulation

Experimental group

Description:

Post procedural prophylactic coagulation of the entire margin of the resection site creating a 2-3mm rim.

Treatment:

Procedure: Snare tip soft coagulation

Standard EMR

No Intervention group

Description:

No prophylactic coagulation