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

Recruiting

• Conditions: Gastric Cancer

• Registration Number: NCT05930860
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-12
• Study First Submitted: 2023-03-02
• Study First Submitted QC: 2023-07-03
• Study First Posted: 2023-07-05
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-12
• Last Update Posted: 2025-03-14
• Primary Completion: 2025-08-12
• Study Completion: 2031-12-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS; 🇮🇹 Rome, Italy