Actively Recruiting
A Multicenter, RCT Study of the Clinical Efficacy of Robotic and Laparoscopic Gastrectomy in Neoadjuvant Gastric Cancer
Led by The Affiliated Hospital of Qingdao University · Updated on 2023-09-21
588
Participants Needed
1
Research Sites
233 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the clinical efficacy of robot radical Gastrectomy and laparoscopic radical Gastrectomy, patients with gastric adenocarcinoma (cT2N+M0 or cT3-4a/N+M0, phase II and III) undergoing neoadjuvant treatment were selected as subjects.
CONDITIONS
Official Title
A Multicenter, RCT Study of the Clinical Efficacy of Robotic and Laparoscopic Gastrectomy in Neoadjuvant Gastric Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged between 18 and 75 years
- Diagnosed with gastric adenocarcinoma confirmed by endoscopic biopsy
- Preoperative clinical staging of stage II or III gastric cancer (cT2N+M0 or cT3-4a/N+M0) confirmed by imaging or laparoscopy
- Completed 2 to 4 cycles of neoadjuvant therapy including chemotherapy with or without targeted or immunotherapy
- Radical gastrectomy feasible after multidisciplinary team discussion
- Preoperative physical condition score of ECOG 0 or 1, or Karnofsky score ≥ 70%
- Preoperative ASA score of I to III
- Expected survival longer than 6 months
- Willing and able to follow the study protocol
- Signed informed consent and aware of the right to withdraw at any time
You will not qualify if you...
- Pregnant or breastfeeding women
- Serious mental illness
- History of upper abdominal surgery except laparoscopic cholecystectomy
- History of gastric surgery except endoscopic submucosal dissection or mucosal resection for gastric cancer
- Moderate to severe kidney failure
- Organ transplant recipients on immunosuppressive therapy
- History of other cancers within the past 5 years
- History of unstable angina or heart attack within 6 months
- History of stroke or brain hemorrhage within 6 months
- Use of systemic corticosteroids continuously within the last month
- Need for surgery for other diseases at the same time (except laparoscopic cholecystectomy)
- Emergency surgery required due to gastric cancer complications like bleeding, perforation, or obstruction
- Lung function with FEV1 less than 50% of expected
- Participation in other clinical trials within the past 6 months
AI-Screening
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Trial Site Locations
Total: 1 location
1
Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital
Qingdao, Shandong, China, 266000
Actively Recruiting
Research Team
Y
Yanbing Zhou
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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