Efficacy and Safety of ESD for the Treatment of Superficial Gastric Neoplasms
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Endoscopic Submucosal Dissection.
- Who it may be relevant to
- Registry conditions: Gastric Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy and Safety of Endoscopic Submucosal Dissection for the Treatment of Superficial Gastric Neoplasms - An Italian Society of Digestive Endoscopy (SIED) Study
Overview
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
- Procedure Endoscopic Submucosal Dissection
Endoscopic Submucosal Dissection
Primary outcome measures
- En bloc resection rate [Time frame: 10 years]
- R0 resection rate [Time frame: 10 years]
- Curative resection rate [Time frame: 10 years]
- Complication rate [Time frame: 10 years]
- Recurrence rate [Time frame: 10 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Case-only
Study locations
Italy · 1 center
- Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Rome
Identifiers
NCT: NCT05930860 · 4349