Clinical trial · Interventional
Phase II Study for Robot Assisted Distal Gastrectomy
A Phase II Study of Robot Assisted Distal Gastrectomy With Nodal Dissection for Clinical Stage Ia Gastric Cancer
NCT01504997CI-TRIAL-00024940RADGphaseIIunknownPhase 2Results postedClinicalTrials.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 aim of this study is to clarify safety of robot assisted distal gastrectomy with lymph node dissection in patients with stage Ia early gastric cancer.
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 |
|---|---|---|---|
| Early Gastric Cancer | Early Gastric Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Robot assisted distal gastrectomy (DaVinci) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Robot assisted distal gastrectomy
- description
- patients who received robot assisted distal gastrectomy
- interventionNames
- Device: Robot assisted distal gastrectomy (DaVinci)
Primary outcomes (1)
- measure
- The Incidence of Post-operative Intra-abdominal Infectious Complications
- timeFrame
- Participants will be followed for the duration of hospital stay, an expected average of 10 days
Secondary outcomes (4)
- measure
- Overall Survival
- timeFrame
- 5 years
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Biopsy specimen from the primary lesion shows adenocarcinoma 2. Diagnosed as Stage IA early gastric cancer according to the preoperative esophagogastroduodenoscopy and computer tomography 3. Endoscopic submucosal dissection is not indicated 4. Tumor was located within lower two thirds of stomach 5. Not having duodenal invasion 6. Eastern clinical oncology group performance status is 0 or 1 7. Body mass index is lower than 30 8. No prior laparotomy 9. No prior chemotherapy or radiation including those for other cancers 10. Fulfil all following conditions WBC \> 3,000/mm3 Plt \> 100,000/mm3 AST \< 100 IU/L ALT \< 100IU/L T.Bil \< 2.0 g/dl Cre \< 1.5mg/dl Exclusion Criteria: 1. Having other active cancers 2. Possibly pregnant, or breast feeding woman 3. with psychiatric disorder 4. Receiving steroids 5. With Acute myocardial infarction in 6 months or with unstable angina 6. With uncontrolled hypertension 7. With uncontrolled diabetes mellitus 8. With pulmonary disease which require continuous oxygen therapy
References
Publications (0)
Data not yet available
No reference posted for this study.