Actively Recruiting
Efficacy and Safety of ESD for the Treatment of Superficial Gastric Neoplasms
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-03-14
200
Participants Needed
1
Research Sites
521 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Efficacy and Safety of ESD for the Treatment of Superficial Gastric Neoplasms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Final diagnosis of non neoplastic lesion
- Gastric neoplasm outside of latest ESD guidelines criteria in patients fit for surgery
- Evidence of muscular layer invasion or lymph nodes or other organs metastasis at EUS or TC when performed
AI-Screening
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Trial Site Locations
Total: 1 location
1
Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Italy
Actively Recruiting
Research Team
F
Federico Barbaro
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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