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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• The Southwest hospital of AMU
  Chongqing, Chongqing Municipality, China Recruiting
• The Southwest hospital of AMU
  Chongqing, Chongqing Municipality, China Not yet recruiting

Study contacts

• Study coordinator: Yan Shi
• Email: shiyandoctor@sina.com
• Phone: 13752909448

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.