Actively Recruiting

Age: 18Years +
All Genders
NCT05930860

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

Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-03-14

200

Participants Needed

1

Research Sites

521 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Italy

Actively Recruiting

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Research Team

F

Federico Barbaro

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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