Clinical trial · Interventional
Laparoscopic vs Open Total Gastrectomy for Gastric Cancer
A Prospective, Multicentral, Open-label, Randomized, Controlled Clinical Trial to Compare the Survival, Morbidity and Mortality of Laparoscopic and Open Total Gastrectomy for Gastric Cancer
NCT05537129CI-TRIAL-00060803recruitingN/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 aim of the present study is to demonstrated the the safety and feasibility of laparoscopic total gastrectomy comparing with open 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Total Gastrectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Laparoscopic Total Gastrectomy
- interventionNames
- Procedure: Total Gastrectomy
- type
- ACTIVE_COMPARATOR
- label
- Open Total Gastrectomy
- interventionNames
- Procedure: Total Gastrectomy
Primary outcomes (1)
- measure
- 3 year-DFS
- timeFrame
- 3 year
- description
- 3 year-disease free survival
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. histologically proven gastric adenocarcinoma in the upper or middle third of the stomach (by preoperative gastrofiberscopy) 2. age between 20 and 80 years old 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 4. clinical stage I-III (T1-4aN0-2M0) according to the 8th edition of the Americal Joint Committee on Cancer System (Clinical stage was determined based on the finding of gastrofiberscopy and abdominal computed tomography) 5. scheduled for total gastrectomy with D2 lymphadenectomy, and possible for R0 surgery by this procedures (Lymphadenectomy is performed on the basis of the criteria of the Japanese 6. written informed consent 7. without preoperative chemotherapy and radiotherapy Exclusion Criteria: 1. clinical stage T1-4N3M0 or T4bN0-3M0 according to the 8th edition of the Americal Joint Committee on Cancer System 2. history of chemotherapy, radiotherapy, immunotherapy or target therapy 3. perigastric lymphnode≥3cm 4. received gastric surgery (i.e. gastrectomy or gastrojejunostomy) 5. multiple primary tumors 6. suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, complicated by poorly controlled hypertension, diabetes, mental disorders or diseases. 7. patients need emergency operation with complication of gastric cancer 8. adhesion due to the previous intraabdominal surgery 9. need for combined organ resection due to aggression of gastric cancer of other disease, 10. vulnerable people who cannot communicate or are pregnant (or planning to be pregnant) 11. currently participating or participated in other clinical trials in the last 6 months
References
Publications (0)
Data not yet available
No reference posted for this study.