Endoscopic Resection of Gastrointestinal Neoplasms

• Conditions: Endoscopic Mucosal Resection; Colonic Neoplasms; Esophageal Neoplasms; Duodenal Neoplasms; Endoscopic Submucosal Dissection; Gastric Neoplasm

• Registration Number: NCT04780256
• Lead Sponsor: Arcispedale Santa Maria Nuova-IRCCS

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-28
• Study First Submitted QC: 2021-02-28
• Study First Posted: 2021-03-03
• Study Start: 2021-03-15
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-19
• Last Update Posted: 2021-07-21
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
recurrence rate	one year	recurrence is the recurrence of the neoplasm at the resection site during follow-up
complete resection rate	one month	the complete resection is the ability to remove the neoplasia with clear margins (R0)
en bloc resection rate	one month	the en bloc resection is the ability to remove the neoplasia in a single piece

Secondary Outcome Measures

Name	Time	Method
adverse events rate	one month	complication rate, early or late, related to the procedure used for endoscopic resection
costs	one month	evaluation of the costs incurred to perform the endoscopic resection

Trial Locations

Locations (1)

IRCCS-AUSL Reggio Emilia; 🇮🇹 Reggio Emilia, RE, Italy