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

NCT05930860 | Recruiting

• 1 other identifier: 4349
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Gastric Cancer

Keywords

Endoscopic Submucosal Dissection; Endoscopic Resection

Outcome Measures

Primary Outcomes (5)

• En bloc resection rate

  removal of the lesion into a single piece.

  10 years

• R0 resection rate

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

  10 years

• Curative resection rate

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

  10 years

• Complication rate

  bleeding, perforation and stenosis.

  10 years

• Recurrence rate

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

  10 years

Interventions

Endoscopic Submucosal Dissection PROCEDURE

Endoscopic Submucosal Dissection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Italy

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Endoscopic Mucosal Resection

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Federico Barbaro

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Federico Barbaro

CONTACT

3921101013; federico.barbaro@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2023
• First Posted: July 5, 2023
• Study Start: December 12, 2021
• Primary Completion: August 12, 2025
• Study Completion (Estimated): December 12, 2031
• Last Updated: March 14, 2025

Record last verified: 2025-03

Locations

IT (1)