Recurrences After Standard EMR vs Plus Thermal Ablation EMR
NCT ID: NCT05121805
Last Updated: 2023-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
306 participants
INTERVENTIONAL
2022-03-17
2024-09-30
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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EMR plus snare tip soft coagulation
Post procedural prophylactic coagulation of the entire margin of the resection site creating a 2-3mm rim.
Snare tip soft coagulation
Thermal ablation of the entire resection margin
Standard EMR
No prophylactic coagulation
No interventions assigned to this group
Interventions
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Snare tip soft coagulation
Thermal ablation of the entire resection margin
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Polyps with any signs of invasive malignancy
* Presence or suspicion of inflammatory bowel disease
* En bloc resection
* Incomplete resection
18 Years
ALL
No
Sponsors
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Maas Hospital Pantein
OTHER
Evangelisches Krankenhaus Düsseldorf
OTHER
Catharina Ziekenhuis Eindhoven
OTHER
Bernhoven Hospital
OTHER
Maasstad Hospital
OTHER
St Jansdal Hospital
OTHER
Bravis Hospital
OTHER
Radboud University Medical Center
OTHER
Responsible Party
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Principal Investigators
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Peter Siersema
Role: PRINCIPAL_INVESTIGATOR
Radboud University Medical Center
Locations
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Radboudumc
Nijmegen, Gelderland, Netherlands
Countries
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Central Contacts
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Facility Contacts
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Gijs Kemper
Role: primary
References
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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.
Other Identifiers
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NL7463209120
Identifier Type: -
Identifier Source: org_study_id