Clinical trial · Interventional
Robotic Total Gastrectomy for Locally Advanced Proximal Gastric Cancer
Clinical Efficacy of Robotic Total Gastrectomy With D2 Lymph Node Dissection for Locally Advanced Proximal Gastric Cancer：A Prospective Trial
NCT03524287CI-TRIAL-00047004completedN/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 purpose of this study is to explore the clinical Efficacy of robotic assisted spleen-preserving No. 10 lymph node dissection for patients with locally advanced upper third 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 Neoplasms | Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Robotic Assisted No.10 Lymph Node Dissections | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- No.10 lymph node dissections
- description
- Patients with locally advanced upper third gastric carcinoma will performed robotic assisted spleen-preserving No.10 lymph node dissections. After the surgery the patients will be treated with oxaliplatin or platinum-based chemotherapy.
- interventionNames
- Procedure: Robotic Assisted No.10 Lymph Node Dissections
Primary outcomes (1)
- measure
- overall postoperative morbidity rates
- timeFrame
- 30 days
- description
- Refers to the incidence of early postoperative complications. The early postoperative complication are defined as the event observed within 30 days after surgery
Secondary outcomes (19)
- measure
- Numbers of No.10 lymph node dissection
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Age between 18 to 75 years old * Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy * Locally advanced tumor in the upper third or middle third of stomach without invading the greater curvature (cT2-4a, N-/+, M0 at preoperative evaluation according to the AJCC (American Joint Committee on Cancer) Cancer Staging Manual Seventh Edition) * No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby in the preoperative examinations * Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale * ASA (American Society of Anesthesiology) class I to III * Written informed consent Exclusion Criteria: * Pregnant and lactating women * Suffering from severe mental disorder * History of previous upper abdominal surgery (except for laparoscopic cholecystectomy) * History of previous gastric surgery (including ESD/EMR (Endoscopic Submucosal --Dissection/Endoscopic Mucosal Resection )for gastric cancer) * Enlarged or bulky regional lymph node （diameter over 3cm）supported by preoperative imaging including enlarged or bulky No.10 lymph node * History of other malignant disease within the past 5 years * History of previous neoadjuvant chemotherapy or radiotherapy * History of unstable angina or myocardial infarction within the past 6 months * History of cerebrovascular accident within the past 6 months * History of continuous systematic administration of corticosteroids within 1 month * Requirement of simultaneous surgery for other disease * Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer * FEV1\<50% of the predicted values * Splenectomy must be performed due to the obvious tumor invasion in spleen or spleen blood vessels.
References
Publications (1)
- DERIVEDZhong Q, Zhang ZQ, Yan YQ, Li YF, He QC, Zheng CH, Chen QY, Huang CM. [Long-term oncological safety of robotic total gastrectomy for locally advanced proximal gastric cancer: a 5-year noninferiority comparison based on the FUGES-014 study]. Zhonghua Wei Chang Wai Ke Za Zhi. 2025 Aug 25;28(8):886-894. doi: 10.3760/cma.j.cn441530-20250610-00218. Chinese. PMID 40850834