Status:
UNKNOWN
Robotic Versus Laparoscopic Distal Gastrectomy With D2 Lymphadenectomy for Locally Advanced Gastric Cancer
Lead Sponsor:
Southwest Hospital, China
Collaborating Sponsors:
Chinese PLA General Hospital
West China Hospital
Conditions:
Gastric Cancer
Eligibility:
All Genders
20-75 years
Phase:
NA
Brief Summary
This study is an investigator-initiated, randomized, controlled, parallel group, and non-inferiority trial comparing robot-assisted gastrectomy with D2 nodal dissection for locally advanced gastric ca...
Detailed Description
Since the first case of laparoscopy-assisted distal gastrectomy was reported in 1994, the number of patients undergoing the laparoscopic procedure has gradually increased. The latest Japanese gastric ...
Eligibility Criteria
Inclusion
- Pathologically proven gastric adenocarcinoma.
- Tumor located in the lower third of the stomach, and is possible to be curatively resected by subtotal gastrectomy.
- Preoperative stage of cT2-4aN0-3M0 according to American Joint Committee on Cancer/Union for International Cancer Control 8th edition
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- American Society of Anesthesiology (ASA) score of class I to III
- Patients who freely give informed consent to participate in the clinical study
Exclusion
- Previous upper abdominal surgery (except laparoscopic cholecystectomy)
- Previous gastric resection (gastrectomy, endoscopic mucosal resection, or endoscopic submucosal dissection)
- Gastric cancer-related complications (complete obstruction or perforation)
- Enlarged or bulky regional lymph node diameter larger than 3 cm based on preoperative imaging
- Previous neoadjuvant chemotherapy or radiotherapy for gastric cancer
- Patients diagnosed with other malignancy within 5 years
- Severe mental disorder
- Unstable angina or myocardial infarction within the past 6 months
- Cerebrovascular accident within the past 6 months
- Severe respiratory disease (FEV1\< 50%)
- Continuous systemic steroid therapy within 1 month before the study
- Pregnant or breast-feeding women
Key Trial Info
Start Date :
September 25 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 25 2022
Estimated Enrollment :
1110 Patients enrolled
Trial Details
Trial ID
NCT03273920
Start Date
September 25 2017
End Date
September 25 2022
Last Update
September 8 2017
Active Locations (14)
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1
Chinese PLA general hospital
Beijing, Beijing Municipality, China, 100853
2
Peking University Cancer Hospital
Beijing, Beijing Municipality, China
3
Department of General Surgery and Center of Microinvasive Gastrointestinal Surgery, Southwest Hospital
Chongqing, Chongqing Municipality, China, 400038
4
Fujian Medical University Union Hospital
Fuzhou, Fujian, China