Clinical trial · Observational
ESD for the Treatment of Early Barrett's Neoplasia
Endoscopic Submucosal Dissection for the Treatment of Early Barrett's Neoplasia
NCT02583087CI-TRIAL-00029306ESTEBANunknownClinicalTrials.gov clinicaltrialsProvenance
- 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)
This study assesses the quality of the resection of early neoplasia arinsing in Barrett's esophagus using endoscopic submucosal dissection. It is a multicenter prospective registry among 7 centers including all consecutive patients with early Barrett's neoplasia of 15 mm or more in size treated by endoscopic submucosal dissection.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Barrett Esophagus | — | UNRESOLVED | — |
| Esophageal Neoplasm | Esophageal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| endoscopic submucosal dissection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Rate of histologically complete (R0) resection of esophageal adenocarcinoma or high grade dysplasia
- timeFrame
- 3 months after ESD initial procedure
- description
- R0 resection rate = horizontal margins free from cancer or high grade dysplasia, and vertical margins free from carcinoma.
Secondary outcomes (7)
- measure
- Rate of en bloc resection via ESD
- timeFrame
- 3 months after ESD initial procedure
- description
- presence of a single fragment of tissue on histopathological analysis
- measure
- Rate of histologically complete (R0) resection of esophageal adenocarcinoma
- timeFrame
- 3 months after ESD initial procedure
- description
- R0 resection rate = horizontal margins free from cancer, and vertical margins free from carcinoma.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Barrett's esophagus at least C0M2 with histological documentation of intestinal metaplasia * Visible abnormality of at least 15 mm in size * Absence of mediastinal or coeliomesenteric enlarged lymph nodes or muscle layer invasion on pretherapeutic EUS * Absence of mediastinal or coeliomesenteric enlarged lymph nodes or metastases on pretherapeutic CT scan Exclusion Criteria: * History of esophageal external irradiation * History of esophagectomy or gastrectomy gastrectomie ou d'oesophagectomie * Esophageal stricture * Esophageal varices grade 3 or of any grade with signs of recent bleeding
References
Publications (0)
Data not yet available
No reference posted for this study.