Observational Recruiting
NCT04780256 on ClinicalTrials.gov
Endoscopic Resection of Gastrointestinal Neoplasms
Official title: Retrospective Study of Efficacy and Safety of the Endoscopic Removal of Cancerous and Precancerous Lesions of the Upper and Lower Digestive Tract
- Sponsor: IRCCS Ospedale San Raffaele
- Enrollment: 2000 (Estimated)
- Study start: 2021-03-15 (Actual)
- Primary completion: 2025-12-01 (Estimated)
- Study completion: 2025-12-01 (Estimated)
- Allocation: N/a
- InterventionModel: N/a
- Masking: None
- PrimaryPurpose: Other
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.
Conditions
- Endoscopic Mucosal Resection
- Endoscopic Submucosal Dissection
- Gastric Neoplasm
- Colonic Neoplasms
- Esophageal Neoplasms
- Duodenal Neoplasms
Intervention / Treatment
- Procedure: Endoscopic resection
Primary Outcome Measures
-
en bloc resection rate
(one month)
the en bloc resection is the ability to remove the neoplasia in a single piece -
complete resection rate
(one month)
the complete resection is the ability to remove the neoplasia with clear margins (R0) -
recurrence rate
(one year)
recurrence is the recurrence of the neoplasm at the resection site during follow-up
Countries
Italy
Locations and Investigators
-
IRCCS-AUSL Reggio Emilia, Reggio Emilia, Italy (Recruiting)
- Matteo Lucarini, MD