Clinical trial · Interventional
Clinical Outcomes of Laparoscopic D1 Versus D2 Lymphadenectomy for Elderly Patients With Advanced Gastric Cancer
Randomized Controlled Trials Comparing Clinical Outcomes of Laparoscopic D1 Versus D2 Lymphadenectomy for Elderly Patients With Advanced Gastric Cancer
NCT03290209CI-TRIAL-00043143D1D2unknownPhase 2ClinicalTrials.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 explore the clinical outcomes of laparoscopic D1 lymphadenectomy for elderly patients with advanced gastric adenocarcinoma（cT2-4a, N-/+, M0）
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 |
|---|---|---|---|
| Stomach Neoplasm | Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laparoscopic D1 Lymphadenectomy | Procedure | — | UNRESOLVED |
| Laparoscopic D2 Lymphadenectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Laparoscopic D1 Lymphadenectomy
- description
- Laparoscopic D1 Lymphadenectomy will be performed for the treatment of patients assigned to this group.
- interventionNames
- Procedure: Laparoscopic D1 Lymphadenectomy
- type
- ACTIVE_COMPARATOR
- label
- Laparoscopic D2 Lymphadenectomy
- description
- Laparoscopic D2 Lymphadenectomy will be performed for the treatment of patients assigned to this group.
- interventionNames
- Procedure: Laparoscopic D2 Lymphadenectomy
Primary outcomes (1)
- measure
- 3-year disease specific survival rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age over or equal to 75 years 2. Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy, including gastric multiple primary carcinoma 3. cT2-4a(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, total or proximal gastrectomy to obtain R0 resection sugicall results. 5. Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale 6. ASA (American Society of Anesthesiology) class I to III 7. Written informed consent Exclusion Criteria: 1. Severe mental disorder 2. History of previous upper abdominal surgery (except laparoscopic cholecystectomy) 3. History of previous gastric surgery (including ESD/EMR (Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection )for gastric cancer) 4. Enlarged or bulky regional lymph node （diameter over 3cm）supported by preoperative imaging 5. History of other malignant disease within the past 5 years 6. History of previous neoadjuvant chemotherapy or radiotherapy 7. History of unstable angina or myocardial infarction within the past 6 months 8. History of cerebrovascular accident within the past 6 months 9. History of continuous systematic administration of corticosteroids within 1 month 10. Requirement of simultaneous surgery for other disease 11. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer 12. FEV1\<50% of the predicted values
References
Publications (0)
Data not yet available
No reference posted for this study.