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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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic Submucosal Dissection | Procedure | Endoscopic Submucosal Dissection |
| Measure | Description | Time Frame |
|---|---|---|
| En bloc resection rate | removal of the lesion into a single piece. | 10 years |
| R0 resection rate | complete removal of the tumor with histologically lateral and vertical margins of the specimen free from dysplasia | 10 years |
| Curative resection rate | R0 resection with combined microstaging parameters not suggestive for high metastatic potential risk. | 10 years |
| Complication rate | bleeding, perforation and stenosis. | 10 years |
| Recurrence rate | dysplastic tissue at the site of resection at follow-up endoscopy. | 10 years |
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Inclusion Criteria:
Exclusion Criteria:
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All patients with gastric superficial neoplasms that can be treated by ESD according to ESGE guidelines or with gastric neoplasm outside of latest ESD guidelines criteria that are unfit for surgery.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Federico Barbaro | Contact | 3921101013 | federico.barbaro@policlinicogemelli.it |
| Name | Affiliation | Role |
|---|---|---|
| Federico Barbaro | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Recruiting | Rome | Italy |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000069916 | Endoscopic Mucosal Resection |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
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| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |