Status:
RECRUITING
A Multicenter, RCT Study of the Clinical Efficacy of Robotic and Laparoscopic Gastrectomy in Neoadjuvant Gastric Cancer
Lead Sponsor:
The Affiliated Hospital of Qingdao University
Conditions:
Gastric Cancer Stage II
Gastric Cancer Stage III
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
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 neoadjuv...
Detailed Description
1. Research background In the world, gastric cancer is a common malignant tumor, with the incidence rate ranking fourth and tumor related deaths ranking second. Although the incidence rate of gastric ...
Eligibility Criteria
Inclusion
- 18 years old ≤ 75 years old male or female;
- The primary gastric lesion was diagnosed as gastric adenocarcinoma (papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, Signet ring cell carcinoma, poorly differentiated adenocarcinoma) by endoscopic biopsy histopathology;
- Before neoadjuvant treatment, the preoperative clinical staging was confirmed to be II and III (cT2N+M0 or cT3-4a/N+M0) through gastroscopy/ultrasound gastroscopy, enhanced CT/MR, or diagnostic laparoscopic exploration (based on AJCC-8th TNM tumor staging);
- 2-4 cycles of neoadjuvant therapy (chemotherapy+/- targeted/immunotherapy, simple chemotherapy);
- After new adjuvant treatment, radical Gastrectomy is feasible after MDT discussion;
- Preoperative ECOG physical condition score of 0/1 or Karst score ≥ 70%;
- Preoperative ASA score I-III;
- The expected survival period exceeds 6 months;
- Willing and able to comply with the research protocol;
- Sign a written informed consent form before enrollment and be fully aware of the right to withdraw from this study at any time.
Exclusion
- Pregnant or lactating women;
- Suffering from serious mental illness;
- History of upper abdominal surgery (excluding history of laparoscopic cholecystectomy);
- History of gastric surgery (excluding ESD/EMR for gastric cancer);
- Moderate to severe renal insufficiency;
- Organ transplant recipients receiving immunosuppressive therapy;
- Have a history of other malignant diseases within 5 years;
- Have a history of unstable angina or myocardial infarction within 6 months;
- Have a history of cerebral infarction or cerebral hemorrhage within 6 months;
- Have a history of continuous systemic corticosteroid therapy within one month;
- Simultaneous surgical treatment of other diseases is required (excluding laparoscopic cholecystectomy);
- Gastric cancer comorbidities (bleeding, perforation, obstruction) requiring emergency surgery;
- Lung function test FEV1\<50% of expected value;
- The patient has participated or is currently participating in other clinical studies (within 6 months).
Key Trial Info
Start Date :
July 7 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2027
Estimated Enrollment :
588 Patients enrolled
Trial Details
Trial ID
NCT06042998
Start Date
July 7 2023
End Date
December 30 2027
Last Update
September 21 2023
Active Locations (1)
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1
Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital
Qingdao, Shandong, China, 266000