Clinical trial · Interventional
Total Robotic Versus Robotic Assisted Distal Gastrectomy for Gastric Cancer
Randomized Controlled Trials on Clinical Outcomes of Total Robotic Versus Robotic Assisted Distal Gastrectomy for Gastric Cancer
NCT04795063CI-TRIAL-00050624not yet recruitingN/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)
To evaluate the clinical efficacy (safety, feasibility and long-term efficacy) of total robotic versus robotic assisted distal gastrectomy for patients with gastric cancer (cT1-4a, N0/+, M0).
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 |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Robotic Gastrectomy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Robotic-Assisted Distal Gastrectomy | Procedure | — | UNRESOLVED |
| Total Robotic Distal Gastrectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Total Robotic Distal Gastrectomy
- description
- After exploration and randomization, patients received total robotic distal gastrectomy
- interventionNames
- Procedure: Total Robotic Distal Gastrectomy
- type
- ACTIVE_COMPARATOR
- label
- Robotic-Assisted Distal Gastrectomy
- description
- After exploration and randomization, patients received robotic-assisted distal gastrectomy.
- interventionNames
- Procedure: Robotic-Assisted Distal Gastrectomy
Primary outcomes (1)
- measure
- Morbidity rates
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age from over 18 to under 75 years 2. Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy 3. cT1-4a (clinical stage tumor), N-/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition 4. expected to perform distal gastrectomy with D1+/D2 lymph node dissection to obtain R0 resection surgicall results. 5. Performance status of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale 6. American Society of Anesthesiology (ASA) class I to III 7. Written informed consent Exclusion Criteria: 1. Women during pregnancy or breast-feeding 2. Severe mental disorder 3. History of previous upper abdominal surgery (except laparoscopic cholecystectomy) 4. History of previous gastric surgery (except Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection (ESD/EMR) for gastric cancer) 5. Gastric multiple primary carcinoma 6. Enlarged or bulky regional lymph node （diameter over 3cm）supported by preoperative imaging 7. History of other malignant disease within the past 5 years 8. History of previous neoadjuvant chemotherapy or radiotherapy 9. History of unstable angina or myocardial infarction within the past 6 months 10. History of cerebrovascular accident within the past 6 months 11. History of continuous systematic administration of corticosteroids within 1 month 12. Requirement of simultaneous surgery for other disease 13. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer 14. Forced expiratory volume in 1 second (FEV1)\<50% of the predicted values
References
Publications (0)
Data not yet available
No reference posted for this study.