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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05930860
• Other study ID #: 4349
• Status: Recruiting
• Start date: December 12, 2021
• Est. completion date: December 12, 2031

Study information

• Verified date: February 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Federico Barbaro
• Phone: 3921101013
• Email: federico.barbaro[@]policlinicogemelli.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 12, 2031
• Est. primary completion date: December 12, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gastric Cancer
• Neoplasms
• Stomach Neoplasms

Intervention

Procedure:
• Endoscopic Submucosal Dissection
Endoscopic Submucosal Dissection

Locations

Country	Name	City	State
Italy	Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

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