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
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 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Italy | IRCCS-AUSL Reggio Emilia | Reggio Emilia | RE |
Lead Sponsor | Collaborator |
---|---|
Arcispedale Santa Maria Nuova-IRCCS |
Italy,
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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