Retrospective Study of Efficacy and Safety of the Endoscopic Removal of Cancerous and Precancerous Lesions of the Upper and Lower Digestive Tract
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 2,000
- Locations
- 1
- Primary Endpoint
- recurrence rate
Study 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)