Endoscopic Resection of Gastrointestinal Neoplasms

September 30, 2025 updated by: Azienda USL Reggio Emilia - IRCCS

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 96 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients> 18 years of age who have undergone endoscopic resection of cancerous or pre-cancerous lesions of the digestive tract will be included in the study

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adverse events rate
Time Frame: one month
complication rate, early or late, related to the procedure used for endoscopic resection
one month
costs
Time Frame: one month
evaluation of the costs incurred to perform the endoscopic resection
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda USL Reggio Emilia - IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2021

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

February 28, 2021

First Submitted That Met QC Criteria

February 28, 2021

First Posted (Actual)

March 3, 2021

Study Record Updates

Last Update Posted (Estimated)

October 3, 2025

Last Update Submitted That Met QC Criteria

September 30, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CORE 3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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