Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05930860

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

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Italy

Location status: Recruiting

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Endoscopic submucosal dissection

Procedure

Endoscopic Submucosal Dissection

Primary outcomes

  1. En bloc resection rate

    Time frame: 10 years

    removal of the lesion into a single piece.

  2. R0 resection rate

    Time frame: 10 years

    complete removal of the tumor with histologically lateral and vertical margins of the specimen free from dysplasia

  3. Curative resection rate

    Time frame: 10 years

    R0 resection with combined microstaging parameters not suggestive for high metastatic potential risk.

  4. Complication rate

    Time frame: 10 years

    bleeding, perforation and stenosis.

  5. Recurrence rate

    Time frame: 10 years

    dysplastic tissue at the site of resection at follow-up endoscopy.

Study contacts

Contact information is provided by the study sponsor or research team.

Federico Barbaro

CONTACT

[email protected]

3921101013

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2031
First posted
Jul 5, 2023
Registry last updated
Mar 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.