Actively Recruiting
Robotic Versus Laparoscopic Radical Surgery for Locally Advanced Gastric Cancer A Multicenter, Prospective, Randomized Controlled Clinical Study
Led by Southwest Hospital, China · Updated on 2025-06-08
740
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the long-term effectiveness and safety of robotic gastrectomy compared to laparoscopic gastrectomy in patients with locally advanced gastric cancer aged between 18 and 75 years. The study aims to determine if the 3-year disease-free survival rate of robotic surgery is not worse than laparoscopic surgery and if robotic surgery offers better safety around the time of surgery. Participants will be randomly assigned to receive either robotic gastrectomy using the da Vinci Surgical System or standard laparoscopic gastrectomy. Both procedures involve preoperative assessments, systematic removal of lymph nodes, subtotal or total removal of the stomach depending on tumor location, and reconstruction. Postoperative care includes close monitoring, pain management, and early mobilization to support recovery. During the trial, participants will have follow-up visits at 30 days, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 2 years, 2.5 years, and 3 years after surgery. These visits will include physical exams, blood tests (such as blood counts, biochemical markers, and tumor markers), and imaging tests like abdominal CT scans, upper gastrointestinal endoscopy, and chest X-rays. Researchers will assess outcomes such as disease-free survival, postoperative complications, and overall survival over three years.
CONDITIONS
Brief Title
Robotic Versus Laparoscopic Radical Surgery for Locally Advanced Gastric Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than 18 years and less than 75 years
- Histological confirmation of primary gastric adenocarcinoma by endoscopic biopsy
- Clinical stage of locally advanced gastric cancer (cT2-4a, N0-3, M0) according to AJCC 8th edition
- No distant metastasis and no direct invasion of pancreas, spleen, or adjacent organs
- ECOG performance status score of 0 or 1 before surgery
- ASA physical status score of I to III before surgery
- Signed informed consent to participate in the study
You will not qualify if you...
- Previous gastric cancer surgery including submucosal or endoscopic mucosal resection
- History of upper abdominal surgery except laparoscopic cholecystectomy
- Regional lymph nodes with confluent enlargement of 3 cm or more on imaging
- Emergency surgery due to gastric tumor bleeding or perforation
- History or presence of other malignancies detected before surgery
- ASA score higher than 3
- Severe psychiatric disorders
- History of unstable angina or myocardial infarction within 6 months
- History of stroke or cerebral hemorrhage within 6 months
- Severe lung disease with FEV1 less than 50%
- Systemic corticosteroid therapy within 1 month prior to the study
- Need for surgery for other diseases at the same time
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to discharge from hospital
Participants undergo either robotic or laparoscopic gastrectomy with systematic D2 lymph node dissection and gastrectomy with reconstruction, followed by close monitoring and management of postoperative recovery.
1 surgery visit and multiple post-operative visits during hospital stay
Duration - Up to 3 years after surgery
Participants are followed for monitoring of disease-free survival, postoperative complications, and overall survival.
Regular follow-up visits over 3 years
Trial Site Locations
Total: 2 locations
1
The Southwest hospital of AMU
Chongqing, Chongqing Municipality, China, 400038
Not Yet Recruiting
2
The Southwest hospital of AMU
Chongqing, Chongqing Municipality, China, 400038
Actively Recruiting
Research Team
Y
Yan Shi
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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