Using endoscopic techniques to treat early gastric cancer
Efficacy and Safety of Endoscopic Submucosal Dissection for the Treatment of Superficial Gastric Neoplasms - An Italian Society of Digestive Endoscopy (SIED) Study
This study is testing a less invasive method called endoscopic submucosal dissection to see if it works better than traditional surgery for treating early-stage stomach cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Rome) |
| Trial ID | NCT05930860 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the efficacy and safety of endoscopic submucosal dissection (ESD) for treating superficial gastric neoplasms. It aims to gather prospective data from a large sample of patients in Italy to assess how well ESD performs compared to traditional surgical methods. The study will create a comprehensive database that includes information on the criteria for using ESD in early gastric neoplasia treatment, following the latest ESGE guidelines. By focusing on less invasive techniques, the study seeks to improve patient outcomes in managing gastric cancer.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with a diagnosis of superficial gastric neoplasm suitable for ESD according to ESGE guidelines.
Not a fit: Patients with non-neoplastic lesions or those who are fit for surgery but have gastric neoplasms outside the latest ESD guidelines may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a less invasive treatment option for patients with early gastric cancer, potentially leading to better recovery outcomes.
How similar studies have performed: Other studies have shown promising results with ESD for early gastric neoplasms, indicating that this approach is both effective and safe.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Rome
- Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Rome, Italy (Recruiting)
Study contacts
- Principal investigator: Federico Barbaro — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Federico Barbaro
- Email: federico.barbaro@policlinicogemelli.it
- Phone: 3921101013
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.