Robotic versus laparoscopic radical surgery for locally advanced stomach and gastroesophageal junction cancer

A Multicenter, Prospective, Randomized Controlled Clinical Study of Robotic Versus Laparoscopic Radical Surgery for Locally Advanced Gastric Cancer

This trial will test whether robotic gastrectomy is as effective as — and safer than — laparoscopic gastrectomy for adults aged 18–74 with locally advanced stomach or gastroesophageal junction cancer.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 740 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Southwest Hospital, China (other)
• Locations: 2 sites (Chongqing, Chongqing Municipality and 1 other locations)
• Trial ID: NCT06791538 on ClinicalTrials.gov

What this trial studies

Adults with histologically confirmed locally advanced gastric or gastroesophageal junction adenocarcinoma (cT2-4a, N0-3, M0) who are fit for surgery are randomly assigned to either robotic or laparoscopic gastrectomy. The trial's co-primary questions are whether 3-year disease-free survival after robotic gastrectomy is non-inferior to laparoscopic gastrectomy and whether perioperative safety is superior with the robotic approach. Participants undergo the assigned surgical procedure and regular follow-up visits including early postoperative checks and longer-term surveillance out to at least three years. The protocol excludes patients with distant metastasis, direct invasion of adjacent organs, prior gastric cancer surgery, or poor preoperative fitness.

Who should consider this trial

Good fit: Ideal candidates are adults 18–74 with endoscopically confirmed gastric adenocarcinoma staged clinically as cT2-4a, N0-3, M0 who have ECOG 0–1 and ASA I–III and no distant metastasis or prior upper abdominal cancer surgery.

Not a fit: Patients with distant metastases, direct invasion of adjacent organs, prior gastric malignancy surgery, significant comorbidities or poor performance status, or those aged 75 and older are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, robotic gastrectomy could provide similar long-term cancer control with fewer perioperative complications and faster recovery.

How similar studies have performed: Smaller and observational studies have shown that robotic gastrectomy can match laparoscopic oncologic outcomes and may reduce some perioperative complications, but randomized long-term comparisons are limited.

Eligibility criteria

Inclusion Criteria:

1. Age \> 18 years and \< 75 years.
2. Primary gastric lesion histologically confirmed as gastric adenocarcinoma (including papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, signet ring cell carcinoma, poorly differentiated adenocarcinoma, etc.) via endoscopic biopsy.
3. Preoperative clinical staging as locally advanced gastric cancer (cT2-4a, N0-3, M0) according to the 8th edition of the AJCC TNM staging system.
4. No distant metastasis on preoperative examination, and no direct invasion of the pancreas, spleen, or other adjacent organs.
5. Preoperative ECOG performance status score of 0 or 1.
6. Preoperative ASA (American Society of Anesthesiologists) physical status score of I-III.
7. Consent to participate in the study and signing of the informed consent form.

Exclusion Criteria:

1. Previous history of gastric malignancy surgery, including submucosal resection and/or endoscopic mucosal resection.
2. History of upper abdominal surgery (excluding laparoscopic cholecystectomy).
3. Preoperative imaging shows regional lymph nodes with confluent enlargement (maximum diameter ≥3cm).
4. Patient underwent emergency surgery due to gastric tumor bleeding or perforation.
5. History of other malignancies, or presence of other malignant tumors detected during preoperative examination.
6. Patient has a history of malignant tumor, or other malignant tumors were found during preoperative examination
7. ASA (American Society of Anesthesiologists) score \>3.
8. Severe psychiatric disorders.
9. History of unstable angina or myocardial infarction within the past 6 months.
10. History of cerebral infarction or cerebral hemorrhage within the past 6 months.
11. Severe pulmonary disease with FEV1 \< 50%.
12. Systemic corticosteroid therapy within 1 month prior to the study.
13. Need for concurrent surgery for other diseases.
14. Pregnant or breastfeeding women.

Where this trial is running

Chongqing, Chongqing Municipality and 1 other locations

• The Southwest hospital of AMU — Chongqing, Chongqing Municipality, China (NOT_YET_RECRUITING)
• The Southwest hospital of AMU — Chongqing, Chongqing Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Yan Shi

Conditions: Gastric Cancer, Gastroesophageal Junction Cancer, Robotic Gastrectomy, Laparoscopic Gastrectomy