RESPECT: Recurrences After Standard EMR vs Plus Thermal Ablation EMR
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 2021 and May 2023 in 1 academic and 3 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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: EMR plus snare tip soft coagulation Post procedural prophylactic coagulation of the entire margin of the resection site creating a 2-3mm rim. |
Procedure: Snare tip soft coagulation
Thermal ablation of the entire resection margin
|
| No Intervention: Standard EMR No prophylactic coagulation |
Outcome Measures
Primary Outcome Measures
- Recurrence [6 months]
Adenoma recurrence at resection site
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Radboudumc | Nijmegen | Gelderland | Netherlands | 6525 |
Sponsors and Collaborators
- Radboud University Medical Center
- Maas Hospital Pantein
- Evangelisches Krankenhaus Düsseldorf
- Catharina Ziekenhuis Eindhoven
- Bernhoven Hospital
Investigators
- Principal Investigator: Peter Siersema, Radboud University Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NL7463209120