Efficacy and Safety of ESD for the Treatment of Superficial Gastric Neoplasms

July 3, 2023 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Efficacy and Safety of Endoscopic Submucosal Dissection for the Treatment of Superficial Gastric Neoplasms - An Italian Society of Digestive Endoscopy (SIED) Study

Endoscopic submucosal dissection (ESD) is the technique that has replaced surgery in the treatment of early neoplastic lesions of the stomach (LNPS). ESD of LNPS allows: a) less invasiveness compared to surgery; b) greater chances of "en bloc" resection and R0 resection compared to mucosectomy for lesions larger than 15 mm. Recent 2015 ESGE guidelines provide precise recommendations for the use of ESD in the treatment of LNPS, but Italy lacks prospective data on the efficacy and safety of ESD in a large sample of patients. A multicenter prospective observational study to create a database on the use of ESD in LNPS is essential to provide information regarding the efficacy and safety of ESD in Italy. This database would also provide information regarding the criteria applied in the use of ESD in the treatment of early gastric neoplasia

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

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

  • Italy
      • Rome, Italy
        • Recruiting
        • Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

All patients with gastric superficial neoplasms that can be treated by ESD according to ESGE guidelines or with gastric neoplasm outside of latest ESD guidelines criteria that are unfit for surgery.

Description

Inclusion Criteria:

  • Age > 18 years old
  • Endoscopic and histologic diagnosis of gastric superficial neoplasm that can be treated by ESD according to ESGE guidelines.
  • Gastric neoplasm outside of latest ESD guidelines criteria in patients unfit for surgery

Exclusion Criteria:

  • Final diagnosis of non neoplastic lesion.
  • Gastric neoplasm outside of latest ESD guidelines criteria in patients fit for surgery
  • Evidence of muscolar layer invasion or limph nodes or other organs metastasis at EUS or TC when performed.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
En bloc resection rate
Time Frame: 10 years
removal of the lesion into a single piece.
10 years
R0 resection rate
Time Frame: 10 years
complete removal of the tumor with histologically lateral and vertical margins of the specimen free from dysplasia
10 years
Curative resection rate
Time Frame: 10 years
R0 resection with combined microstaging parameters not suggestive for high metastatic potential risk.
10 years
Complication rate
Time Frame: 10 years
bleeding, perforation and stenosis.
10 years
Recurrence rate
Time Frame: 10 years
dysplastic tissue at the site of resection at follow-up endoscopy.
10 years

Collaborators and Investigators

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

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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)

December 12, 2021

Primary Completion (Estimated)

December 12, 2024

Study Completion (Estimated)

December 12, 2031

Study Registration Dates

First Submitted

March 2, 2023

First Submitted That Met QC Criteria

July 3, 2023

First Posted (Actual)

July 5, 2023

Study Record Updates

Last Update Posted (Actual)

July 5, 2023

Last Update Submitted That Met QC Criteria

July 3, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4349

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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