Endoscopic Resection of Gastrointestinal Neoplasms

NCT ID: NCT04780256

Last Updated: 2025-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-15

Study Completion Date

2025-12-31

Brief Summary

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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

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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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 gastrointestinal wall

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda USL Reggio Emilia - IRCCS

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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IRCCS-AUSL Reggio Emilia

Reggio Emilia, RE, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Paolo Cecinato, MD

Role: CONTACT

+390522296111

Facility Contacts

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Matteo Lucarini, MD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 36542136 (View on PubMed)

Other Identifiers

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CORE 3

Identifier Type: -

Identifier Source: org_study_id

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