Clinical trial · Interventional
Efficacy and Safety Study of Endoscopic Submucosal Dissection for Early Gastric Cancer
Long-term Follow-up After Endoscopic Submucosal Dissection for Early Gastric Cancer
NCT01132469CI-TRIAL-00003497ESDunknownN/AClinicalTrials.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)
The purpose of this study is to evaluate the safety and clinical effectiveness of ESD(Endoscopic Submucosal Dissection) for early gastric cancer analyzing short-term and long-term results of endoscopic treatment.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Early Gastric Cancer | Early Gastric Carcinoma | ALIAS | 0.90 |
| Endoscopic Submucosal Dissection | — | UNRESOLVED | — |
| Historical Control Group | — | UNRESOLVED | — |
| Multi-center, Single-arm Clinical Trial | — | UNRESOLVED | — |
| Quality of Life and Cost Analysis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endoscopic Submucosal Dissection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Endoscopic Submucosal Dissection
- description
- Single-arm for ESD procedure and retrospective surgical procedure(Laparoscopy, Open surgery)data collection
- interventionNames
- Procedure: Endoscopic Submucosal Dissection
Primary outcomes (1)
- measure
- 5-year disease(gastric cancer)-free survival rate after ESD procedure
- timeFrame
- 5 years after ESD
Secondary outcomes (5)
- measure
- Short-term result(Histological complete resection,complication)
- timeFrame
- within the first 7 days after ESD
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
1. ESD GROUP Inclusion Criteria: * Korean people aged \>=20 years * Endoscopic Grossly the lesion diameter ≤ 3cm * Endoscopic biopsy results: Well-differentiated and moderately differentiated adenocarcinoma * No ulcers in lesions * Endoscopic biopsy results: In case of gastric cancer, no metastasis in CT test performed before ESD procedure Exclusion Criteria: * Subject with history of malignant disease in other organs * Subject with history of stomach surgery due to peptic ulceration etc. * As the cases of an absolute contraindication of general anesthesia; Subject with chronic liver disease over Child score B, Subject with chronic Renal Disease requiring hemodialysis or peritoneal dialysis, Subject with heart failure more than Ⅲ score according to New York Heart Association Classification, Subject with severe systemic diseases such as respiratory disease * Subject with Bleeding tendency * Pregnant woman or woman with possibility of pregnancy * Subject who cann't be obtained informed consent * Subject who is unable to follow up for any other reason 2. Surgery Group(Retrospective data collection) Inclusion Criteria: * Subject with gastric laparoscopy or open-surgery for treatment early gastric cancer during 2002.1.1 \~2004. 12. 31 * Korean people aged \>=20 years * Early gastric cancer confirmed by pathology during gastric surgery; Gastric cancer confirmed to the mucosal or submucosal regardless of lymph node metastasis * No history of malignant disease in other organs * No history of stomach surgery due to peptic ulceration etc.
References
Publications (0)
Data not yet available
No reference posted for this study.