Comparing robotic and laparoscopic surgery for advanced gastric cancer

A Prospective, Multicenter, Randomized, Controlled Study of the Clinical Efficacy of Robotic and Laparoscopic Radical Gastrectomy in Neoadjuvant Gastric Cancer Patients

This study is testing whether robotic surgery or traditional laparoscopic surgery works better for people with advanced stomach cancer after they have received initial treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 588 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: The Affiliated Hospital of Qingdao University (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Qingdao, Shandong)
• Trial ID: NCT06042998 on ClinicalTrials.gov

What this trial studies

This study evaluates the clinical efficacy of robotic versus laparoscopic radical gastrectomy in patients with stage II and III gastric adenocarcinoma undergoing neoadjuvant treatment. It aims to determine which surgical approach offers better short-term clinical outcomes following neoadjuvant therapy. The study involves patients diagnosed with gastric cancer who have undergone preoperative staging and are deemed suitable for radical surgery after a multidisciplinary team discussion. The research is conducted at a single center in China, focusing on a population with a high incidence of gastric cancer.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with stage II or III gastric adenocarcinoma who have undergone neoadjuvant therapy.

Not a fit: Patients with early-stage gastric cancer or those who are not eligible for radical gastrectomy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved surgical outcomes and survival rates for patients with advanced gastric cancer.

How similar studies have performed: Previous studies have shown promising results for laparoscopic approaches in gastric cancer, but this specific comparison with robotic surgery is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. 18 years old ≤ 75 years old male or female;
2. 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;
3. 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);
4. 2-4 cycles of neoadjuvant therapy (chemotherapy+/- targeted/immunotherapy, simple chemotherapy);
5. After new adjuvant treatment, radical Gastrectomy is feasible after MDT discussion;
6. Preoperative ECOG physical condition score of 0/1 or Karst score ≥ 70%;
7. Preoperative ASA score I-III;
8. The expected survival period exceeds 6 months;
9. Willing and able to comply with the research protocol;
10. Sign a written informed consent form before enrollment and be fully aware of the right to withdraw from this study at any time.

Exclusion Criteria:

1. Pregnant or lactating women;
2. Suffering from serious mental illness;
3. History of upper abdominal surgery (excluding history of laparoscopic cholecystectomy);
4. History of gastric surgery (excluding ESD/EMR for gastric cancer);
5. Moderate to severe renal insufficiency;
6. Organ transplant recipients receiving immunosuppressive therapy;
7. Have a history of other malignant diseases within 5 years;
8. Have a history of unstable angina or myocardial infarction within 6 months;
9. Have a history of cerebral infarction or cerebral hemorrhage within 6 months;
10. Have a history of continuous systemic corticosteroid therapy within one month;
11. Simultaneous surgical treatment of other diseases is required (excluding laparoscopic cholecystectomy);
12. Gastric cancer comorbidities (bleeding, perforation, obstruction) requiring emergency surgery;
13. Lung function test FEV1\<50% of expected value;
14. The patient has participated or is currently participating in other clinical studies (within 6 months).

Where this trial is running

Qingdao, Shandong

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

Study contacts

• Study coordinator: Yanbing Zhou

Conditions Gastric Cancer Stage II; Gastric Cancer Stage III; Neoadjuvant therapy; gastric cancer; robot radical gastrectomy; laparoscopic Gastrectomy; short-term clinical outcome; prognosis