A Multicenter, RCT Study of the Clinical Efficacy of Robotic and Laparoscopic Gastrectomy in Neoadjuvant Gastric Cancer

Recruiting now · Not applicable

Conditions studied: Gastric Cancer Stage II, Gastric Cancer Stage III

In brief

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.

Key facts

Study ID

NCT06042998

Run by

The Affiliated Hospital of Qingdao University

People needed

588

Starts

2023-07-07

Expected to finish

2027-12-30

Last updated by the study team

2023-09-21

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital — Qingdao, Shandong, China (enrolling)

Full record on ClinicalTrials.gov

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