Efficacy, Safety and Recurrence After Cold-EMR Plus APC for Large Colonic Lesions

NCT ID: NCT06435377

Last Updated: 2024-05-30

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-01

Study Completion Date

2025-06-30

Brief Summary

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This prospective observational study aims to evaluate the efficacy, safety and recurrence of cold-snaring for large colonic lesions combined with argon plasma coagulation of the resection bed.

Detailed Description

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Conditions

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Colonic Disease

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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Procedure: Cold EMR + APC

* Initial submucosal injection of saline solution and methylene blue, followed by 'piece-meal' resection using a dedicated cold snare
* Biopsy of the resection bed
* Ablation of the defect using argon plasma coagulation (APC).

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* All patients aged ≧ 18 years undergoing colonoscopy for any indication (screening, anemia, surveillance, or scheduled to undergo endoscopic mucosal resection)
* Lesions of 20 mm and larger.
* All colonic lesions removed using COLD-EMR technique, presenting both adenomatous (Kudo IIIL/IIIS pit pattern)
* Patients who were able to provide written informed consent

Exclusion Criteria

* Suspected lesions for submucosal invasion (e.g., Kudo V or Paris 0-IIa-IIc with non-granular surface)
* Lesions with a wide Paris 0-Is component (\>10mm) that could increase the risk of submucosal invasion and could limit the mechanical cutting of the snare
* Pedunculated polyps
* Active/quiescent colitis
* Rectal lesions
* Residual or recurrent adenoma after endoscopic mucosal resection
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istituto Clinico Humanitas

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Endoscopy Unit, Gastroenterology Department, Humanitas Research Hospital

Rozzano, Milano, Italy

Site Status

Countries

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Italy

Other Identifiers

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Cold-EMR plus APC

Identifier Type: -

Identifier Source: org_study_id

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