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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
View:

• 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

Locations
Other Locations
Italy
Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
RECRUITING
Rome
Contact Information
Primary
Federico Barbaro
federico.barbaro@policlinicogemelli.it
3921101013
Time Frame
Start Date: 2021-12-12
Estimated Completion Date: 2031-12-12
Participants
Target number of participants: 200
Related Therapeutic Areas
Sponsors
Leads: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

This content was sourced from clinicaltrials.gov