Actively Recruiting
Robotic Versus Laparoscopic Radical Surgery for Locally Advanced Gastric Cancer
Led by Southwest Hospital, China · Updated on 2025-06-08
740
Participants Needed
2
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This \[Study Type: Clinical Trial\] aims to \[Primary Objective: evaluate the long-term efficacy and safety of robotic gastrectomy for locally advanced gastric cancer\] in \[Participant Population: patients with locally advanced gastric cancer, aged \>18 years and \<75 years\]. The primary questions it seeks to answer are: Is the 3-year disease-free survival rate of robotic gastrectomy non-inferior to that of laparoscopic gastrectomy? Is the perioperative safety of robotic gastrectomy superior to that of laparoscopic gastrectomy? Researchers will compare \[Intervention Groups: Robotic Gastrectomy vs. Laparoscopic Gastrectomy\] to determine whether \[robotic surgery offers advantages in long-term efficacy and perioperative safety\]. Participants will: Sign an informed consent form and be randomly assigned to either the robotic surgery group or the laparoscopic surgery group. Undergo the assigned surgical procedure and receive regular 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 postoperatively). Complete physical examinations, blood tests (including complete blood count, biochemical markers, and tumor markers), and imaging studies (such as abdominal CT, upper gastrointestinal endoscopy, and chest X-ray) during the follow-up period.
CONDITIONS
Official Title
Robotic Versus Laparoscopic Radical Surgery for Locally Advanced Gastric Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years and under 75 years
- Histologically confirmed primary gastric adenocarcinoma by endoscopic biopsy
- Clinical staging of locally advanced gastric cancer (cT2-4a, N0-3, M0) according to AJCC 8th edition
- No distant metastasis or 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 over 3 cm on imaging
- Emergency surgery due to gastric tumor bleeding or perforation
- History or presence of other malignant tumors detected before surgery
- ASA score greater 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 before study
- Need for additional surgery for other diseases
- Pregnancy or breastfeeding
AI-Screening
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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
CONTACT
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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