An interventional study of Snare tip soft coagulation in Polyps of Colon and Recurrence, Local Neoplasm, sponsored by Radboud University Medical Center. Status unknown at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-26.
Sponsored by Radboud University Medical Center · Not applicable, Interventional, and Treatment
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.
36 studies on the registry are indexed under Neoplasm Recurrence, Local; 13 are open to participants now.
This study's planned enrollment of 306 is above the median of 237 across 26 interventional studies indexed under Neoplasm Recurrence, Local.
Browse Neoplasm Recurrence, Local studies →Radboud University Medical Center is the lead sponsor of 959 studies on the registry; 134 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Post procedural prophylactic coagulation of the entire margin of the resection site creating a 2-3mm rim.
Procedure: Snare tip soft coagulation
No prophylactic coagulation
Thermal ablation of the entire resection margin
Recurrence
Adenoma recurrence at resection site
Time frame: 6 months
Plan to share: No — There is no particular plan. But the investigators are willing to share the data with colleagues depending which research question they want to answer.
No publications or documents are linked to this record.
This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Radboud University Medical Center