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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05930860

Enrollment

200

Registered

2023-07-05

Start date

2021-12-12

Completion date

2031-12-12

Last updated

2025-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

Keywords

Endoscopic Submucosal Dissection, Endoscopic Resection

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

Interventions

PROCEDUREEndoscopic Submucosal Dissection

Endoscopic Submucosal Dissection

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Italy

Contacts

Primary ContactFederico Barbaro

federico.barbaro@policlinicogemelli.it3921101013

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026