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Clinical Trials/NCT06435377
NCT06435377
Not yet recruiting
Not Applicable

Prospective Observational Study APC AND BIOPSY POST COLD-EMR IN COLONIC LESIONS

Istituto Clinico Humanitas1 site in 1 country60 target enrollmentJuly 1, 2024
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ConditionsColonic Disease

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colonic Disease
Sponsor
Istituto Clinico Humanitas
Enrollment
60
Locations
1
Primary Endpoint
Residual
Status
Not yet recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2024
End Date
June 30, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Istituto Clinico Humanitas
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Residual

Time Frame: 1 day

Evaluation of residual in the biopsy of the defect after the cold-EMR. The specimen will be evaluated independently from the polyp sample.

Recurrence

Time Frame: 1 year

The recurrence rate of adenomas at the site of any qualifying, previously resected lesions is measured after 3-6 and 12 months.

Secondary Outcomes

  • perforation(1 day)
  • Efficacy of procedure(1 day)
  • Rate of delayed bleeding of the patient(1 day)
  • Time(1 day)
  • Rate of post-polipectomy syndrome(1 day)

Study Sites (1)

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