Trials / Unknown
UnknownNCT05121805
Recurrences After Standard EMR vs Plus Thermal Ablation EMR
Recurrences After Standard EMR vs Plus Thermal Ablation EMR of Advanced Sessile and Lateral Spreading Colorectal Adenoma
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 306 (estimated)
- Sponsor
- Radboud University Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Snare tip soft coagulation | Thermal ablation of the entire resection margin |
Timeline
- Start date
- 2022-03-17
- Primary completion
- 2024-04-01
- Completion
- 2024-09-01
- First posted
- 2021-11-16
- Last updated
- 2023-12-26
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT05121805. Inclusion in this directory is not an endorsement.