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Recruiting NCT04780256

Endoscopic Resection of Gastrointestinal Neoplasms

Observational Endoscopic Mucosal Resection Endoscopic Submucosal Dissection Gastric Neoplasm Colonic Neoplasms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Endoscopic resection.
Who it may be relevant to
Registry conditions: Endoscopic Mucosal Resection, Endoscopic Submucosal Dissection, Gastric Neoplasm, Colonic Neoplasms. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • Procedure Endoscopic resection
    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 g

Primary outcome measures

  • en bloc resection rate [Time frame: one month]
  • complete resection rate [Time frame: one month]
  • recurrence rate [Time frame: one year]
Secondary outcome measures (2)
  • adverse events rate [Time frame: one month]
  • costs [Time frame: one month]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • IRCCS-AUSL Reggio Emilia — Reggio Emilia

Publications

  • 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

Identifiers

NCT: NCT04780256 · CORE 3

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗