Status:
NOT_YET_RECRUITING
Hot EMR vs Underwater Cold EMR for Large Colonic Adenomas
Lead Sponsor:
Istituto Clinico Humanitas
Conditions:
Colonic Neoplasms
Colonic Adenoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This randomized, multi-center trial aims to evaluate the advantages of underwater cold endoscopic mucosal resection technique (CS-EMR) in comparison to the conventional endoscopic mucosal resection te...
Detailed Description
Endoscopic mucosal resection stands as one of the most commonly employed techniques for the removal of gastrointestinal lesions, particularly within the colon. "Piece-meal" endoscopic mucosal resectio...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- all patients ≥ 18 years of age undergoing colonoscopy for any indication (screening, anaemia, surveillance)
- patients who were able to give informed written consent.
- Exclusion criteria:
- lesions suspicious for submucosal invasion (e.g. Kudo V or Paris 0-IIa-IIc with nongranular surface).
- lesions with large (\>10 mm) Paris 0-Is component that could compromise the nodular en-bloc resection and increase risk of submucosal invasion.
- suspected sessile serrated adenomas (SSAs) according to traditional features such as adherent surface mucus, cloud-like surface, interruption of mucosal vessels, Kudo II-o pit pattern.
- pedunculated polyps
- active/quiescent colitis
- patients with other lesions resected by hot snare during the same procedure.
- rectal lesions
- residual or recurrent adenoma after endoscopic mucosal resection
Exclusion
Key Trial Info
Start Date :
April 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
330 Patients enrolled
Trial Details
Trial ID
NCT06217250
Start Date
April 15 2024
End Date
January 1 2026
Last Update
April 18 2024
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