Clinical trial · Interventional
The Safety of Totally Laparoscopic Versus Laparoscopy-Assisted Total Gastrectomy.
A Multicenter, Randomized, Controlled Clinical Trial of the Safety of Totally Laparoscopic Versus Laparoscopy-Assisted Total Gastrectomy for Gastric Cancer.
NCT04351321CI-TRIAL-00044709unknownN/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 compare the short-term surgical safety and postoperative quality of life of totally laparoscopic versus laparoscopy-assisted total gastrectomy and to evaluate the superiority of totally laparoscopic total gastrectomy.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laparoscopy-Assisted Total Gastrectomy | Procedure | — | UNRESOLVED |
| Totally Laparoscopic Total Gastrectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Totally Laparoscopic Total Gastrectomy
- description
- Totally laparoscopic total gastrectomy will be performed for the treatment of patients assigned to this group.
- interventionNames
- Procedure: Totally Laparoscopic Total Gastrectomy
- type
- ACTIVE_COMPARATOR
- label
- Laparoscopy-Assisted Total Gastrectomy
- description
- Laparoscopy-assisted total gastrectomy will be performed for the treatment of patients assigned to this group.
- interventionNames
- Procedure: Laparoscopy-Assisted Total Gastrectomy
Primary outcomes (1)
- measure
- The incidence of postoperative morbidity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Aged 18-75 years; 2. Primary lesion is diagnosed with endometrial biopsy as adenocarcinoma of the stomach or esophagogastric junction, including: papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, poorly cohesive carcinoma (including signet ring cell carcinoma and other variants), mixed adenocarcinoma, etc.; 3. Clinical stage cT1N0M0, cT1N1M0, cT2N0M0; 4. The gastric primary lesion is located in the body or fundus of stomach or the esophagogastric junction. It is expected that total gastrectomy with D1+/D2 lymph node dissection achieves R0 resection (multiple primary cancers are also applicable); 5. BMI(Body Mass Index)\<30 kg/m2; 6. No history of upper abdominal surgery (except for laparoscopic cholecystectomy); 7. No prior treatment of chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.; 8. Preoperative ECOG (Eastern Cooperative Oncology Group) performance status score 0 or 1; 9. Preoperative ASA (American Society of Anesthesiologists) scoring I-III; 10. Sufficient vital organ functions; 11. Signed informed consent. Exclusion Criteria: 1. Preoperative examination indicates disease stage cStage II or above; 2. Women during pregnancy or lactation; 3. Suffer from other malignant tumors within 5 years; 4. Preoperative body temperature ≥ 38°C or complicated with infectious diseases requiring systemic treatment; 5. Severe mental illness; 6. Severe respiratory disease; 7. Severe liver and kidney dysfunction; 8. History of unstable angina or myocardial infarction within 6 months; 9. History of cerebral infarction or cerebral hemorrhage within 6 months; 10. Continuous application of glucocorticoid within 1 month (except for topical application); 11. Accompanied by gastric cancer complications (bleeding, perforation, obstruction, etc.) ; 12. The patient has participated in or is participating in other clinical studies (within 6 months).
References
Publications (0)
Data not yet available
No reference posted for this study.