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Clinical Trials/NCT04780256
NCT04780256
Recruiting
Not Applicable

Retrospective Study of Efficacy and Safety of the Endoscopic Removal of Cancerous and Precancerous Lesions of the Upper and Lower Digestive Tract

Azienda USL Reggio Emilia - IRCCS1 site in 1 country2,000 target enrollmentMarch 15, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Endoscopic Mucosal Resection
Sponsor
Azienda USL Reggio Emilia - IRCCS
Enrollment
2000
Locations
1
Primary Endpoint
recurrence rate
Status
Recruiting
Last Updated
7 months ago

Overview

Brief Summary

The study aims to retrospectively investigate the endoscopic resection procedures of cancerous and precancerous lesions of the upper and lower digestive tract in order to evaluate the efficacy and safety outcomes and to compare different resection techniques. In particular, the resection techniques investigated will be mucosectomy, en bloc and piecemeal, endoscopic submucosal dissection (ESD) and its variants, full-thickness resection. The anatomical districts involved will be the esophagus, stomach, duodenum, colon and rectum.

Registry
clinicaltrials.gov
Start Date
March 15, 2021
End Date
December 1, 2025
Last Updated
7 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Azienda USL Reggio Emilia - IRCCS
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 18 years or older
  • all patients who have undergone endoscopic resection of an upper or lower digestive tract tumor

Exclusion Criteria

  • age under 18
  • inability to provide informed consent

Outcomes

Primary Outcomes

recurrence rate

Time Frame: one year

recurrence is the recurrence of the neoplasm at the resection site during follow-up

complete resection rate

Time Frame: one month

the complete resection is the ability to remove the neoplasia with clear margins (R0)

en bloc resection rate

Time Frame: one month

the en bloc resection is the ability to remove the neoplasia in a single piece

Secondary Outcomes

  • adverse events rate(one month)
  • costs(one month)

Study Sites (1)

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