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
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
En bloc resection rate — 10 years removal of the lesion into a single piece.
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.
Complication rate — 10 years bleeding, perforation and stenosis.
Recurrence rate — 10 years dysplastic tissue at the site of resection at follow-up endoscopy.
Trial sites (1)
Facility
City
Region
Status
Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome
Italy
Recruiting
More Fondazione Policlinico Universitario Agostino Gemelli IRCCS trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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