RecruitingNCT05930860

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


Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrollment

200 participants

Start Date

Dec 12, 2021

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tracks the outcomes of a minimally invasive stomach procedure called ESD (endoscopic submucosal dissection) — used to remove early stomach tumors through a camera — to understand how well it works in real-world practice. **You may be eligible if...** - You are over 18 years old - You have been diagnosed with a superficial (early-stage) stomach tumor or growth that qualifies for ESD according to current guidelines - You have a stomach growth outside the standard ESD guidelines but are not fit enough for surgery **You may NOT be eligible if...** - Your lesion turns out to be non-cancerous on final analysis - You have a stomach tumor outside ESD guidelines but you are still fit enough for surgery - Imaging shows that the cancer has grown into the muscle layer of the stomach wall, or has spread to lymph nodes or other organs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREEndoscopic Submucosal Dissection

Endoscopic Submucosal Dissection


Locations(1)

Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Italy

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NCT05930860


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