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Endoscopic Resection of Gastrointestinal Neoplasms

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04780256
Enrollment
2000
Registered
2021-03-03
Start date
2021-03-15
Completion date
2025-12-31
Last updated
2025-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endoscopic Mucosal Resection, Endoscopic Submucosal Dissection, Gastric Neoplasm, Colonic Neoplasms, Esophageal Neoplasms, Duodenal Neoplasms

Keywords

Endoscopic mucosal resection (EMR), Endoscopic submucosal dissection (ESD), Endoscopic full thickness resection (EFTR), Colorectal ESD, Colorectal EMR

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.

Interventions

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: 1. Endoscopic mucosal resection (EMR): it allows to remove mucosal lesions 2. Endoscopic submucosal dissection: it allows to remove mucosal lesions that involved submucosal layer and large lesions 3. Full-thickness resection: it allows to remove infiltrating lesions by the resection of a little piece of the entire gastrointestinal wall

Sponsors

Azienda USL Reggio Emilia - IRCCS
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
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

Design outcomes

Primary

MeasureTime frameDescription
en bloc resection rateone monththe en bloc resection is the ability to remove the neoplasia in a single piece
complete resection rateone monththe complete resection is the ability to remove the neoplasia with clear margins (R0)
recurrence rateone yearrecurrence is the recurrence of the neoplasm at the resection site during follow-up

Secondary

MeasureTime frameDescription
adverse events rateone monthcomplication rate, early or late, related to the procedure used for endoscopic resection
costsone monthevaluation of the costs incurred to perform the endoscopic resection

Countries

Italy

Contacts

Primary ContactPaolo Cecinato, MD
paolo.cecinato@ausl.re.it+390522296111

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026