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NCT04780256 Clinical Trial

Endoscopic Resection of Gastrointestinal Neoplasms

Esophageal Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04780256
Other study ID # CORE 3
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 15, 2021
Est. completion date December 2022

Study information
Verified date July 2021
Source Arcispedale Santa Maria Nuova-IRCCS
Contact Paolo Cecinato, MD
Phone +393476117414
Email paolo.cecinato@ausl.re.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 2000
Est. completion date December 2022
Est. primary completion date December 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Endoscopic resection
The endoscopic resection is the procedure that allows to remove cancerous or precancerous conditions of digestive tract. Endoscopic resection can be preformed by several techniques: Endoscopic mucosal resection (EMR): it allows to remove mucosal lesions Endoscopic submucosal dissection: it allows to remove mucosal lesions that involved submucosal layer and large lesions Full-thickness resection: it allows to remove infiltrating lesions by the resection of a little piece of the entire gastrointestinal wall

Locations
Country Name City State
Italy IRCCS-AUSL Reggio Emilia Reggio Emilia RE

Sponsors (1)
Lead Sponsor Collaborator
Arcispedale Santa Maria Nuova-IRCCS

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary en bloc resection rate the en bloc resection is the ability to remove the neoplasia in a single piece one month
Primary complete resection rate the complete resection is the ability to remove the neoplasia with clear margins (R0) one month
Primary recurrence rate recurrence is the recurrence of the neoplasm at the resection site during follow-up one year
Secondary adverse events rate complication rate, early or late, related to the procedure used for endoscopic resection one month
Secondary costs evaluation of the costs incurred to perform the endoscopic resection one month
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