Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endoscopic Submucosal Dissection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (5)
- measure
- En bloc resection rate
- timeFrame
- 10 years
- description
- removal of the lesion into a single piece.
- measure
- R0 resection rate
- timeFrame
- 10 years
- description
- complete removal of the tumor with histologically lateral and vertical margins of the specimen free from dysplasia
- measure
- Curative resection rate
- timeFrame
- 10 years
- description
- R0 resection with combined microstaging parameters not suggestive for high metastatic potential risk.
- measure
- Complication rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available