Endoscopic Resection of Gastrointestinal Neoplasms

NCT04780256 — Recruiting, 2000 participants, Azienda USL Reggio Emilia - IRCCS

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

Registry	NCT04780256
Status	Recruiting
Study type	Observational
Enrollment	2000 (Estimated)
Sponsor	Azienda USL Reggio Emilia - IRCCS (Other gov)
Conditions	Endoscopic Mucosal Resection, Endoscopic Submucosal Dissection, Gastric Neoplasm, Colonic Neoplasms, Esophageal Neoplasms, Duodenal Neoplasms
Interventions	Endoscopic resection (Procedure)
Dates	start 2021-03-15, primary completion 2025-12-01 (estimated), completion 2025-12-01 (estimated), first posted 2021-03-03, last updated 2025-10-03
Locations	1 site in Italy

-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.

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+Arms and interventions

Endoscopic resection (Procedure): 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

+Outcome measures

Primary outcomes

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

Secondary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to 100 Years

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

+Locations (1)

Facility	City	Country	Status
IRCCS-AUSL Reggio Emilia	Reggio Emilia, RE	Italy	Recruiting

+Publications

Results publication: Cecinato P, Lisotti A, Azzolini F, Lucarini M, Bassi F, Fusaroli P, Sassatelli R. Left colonic localization, non-granular morphology, and pit pattern independently predict submucosal fibrosis of naive colorectal neoplasms before endoscopic submucosal dissection. Surg Endosc. 2023 Apr;37(4):3037-3045. doi: 10.1007/s00464-022-09828-0. Epub 2022 Dec 21. PMID 36542136