Efficacy and Safety of Endoscopic Submucosal Dissection for the Treatment of Superficial Gastric Neoplasms - An Italian Society of Digestive Endoscopy (SIED) Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Gastric Cancer
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Recurrence rate
- Status
- Recruiting
- Last Updated
- last year
Overview
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
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Recurrence rate
Time Frame: 10 years
dysplastic tissue at the site of resection at follow-up endoscopy.
R0 resection rate
Time Frame: 10 years
complete removal of the tumor with histologically lateral and vertical margins of the specimen free from dysplasia
Curative resection rate
Time Frame: 10 years
R0 resection with combined microstaging parameters not suggestive for high metastatic potential risk.
Complication rate
Time Frame: 10 years
bleeding, perforation and stenosis.
En bloc resection rate
Time Frame: 10 years
removal of the lesion into a single piece.