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| Name | Class |
|---|---|
| Maas Hospital Pantein | OTHER |
| Evangelisches Krankenhaus Düsseldorf | OTHER |
| Catharina Ziekenhuis Eindhoven | OTHER |
| Bernhoven Hospital |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EMR plus snare tip soft coagulation | Experimental | Post procedural prophylactic coagulation of the entire margin of the resection site creating a 2-3mm rim. |
|
| Standard EMR | No Intervention | No prophylactic coagulation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Snare tip soft coagulation | Procedure | Thermal ablation of the entire resection margin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence | Adenoma recurrence at resection site | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gijs Kemper, MD | Contact | 31 614945308 | gijs.kemper@radboudumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Peter Siersema | Radboud University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboudumc | Recruiting | Nijmegen | Gelderland | 6525 | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38368409 | Derived | Kemper G, Gerges C, Schoon EJ, Schreuder RM, Schrauwen RRW, Epping LSM, Beyna T, Drenth JPH, Gundug U, Siersema PD, van Geenen EJM; ENDOCARE study group. Recurrences of advanced sessile and lateral spreading colorectal adenoma after endoscopic mucosal resection (EMR) thermal ablation versus no adjuvant therapy (RESPECT): a protocol of an international randomized controlled trial. Trials. 2024 Feb 17;25(1):132. doi: 10.1186/s13063-024-07915-2. |
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There is no particular plan. But the investigators are willing to share the data with colleagues depending which research question they want to answer.
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| ID | Term |
|---|---|
| D003111 | Colonic Polyps |
| D009364 | Neoplasm Recurrence, Local |
| ID | Term |
|---|---|
| D007417 | Intestinal Polyps |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| OTHER |
| Maasstad Hospital | OTHER |
| St Jansdal Hospital | OTHER |
| Bravis Hospital | OTHER |
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| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |