Robotic Versus Laparoscopic Radical Surgery for Locally Advanced Gastric Cancer (NCT06791538) | Clinical Trial Compass
RecruitingNot Applicable
Robotic Versus Laparoscopic Radical Surgery for Locally Advanced Gastric Cancer
China740 participantsStarted 2025-02-01
Plain-language summary
This \[Study Type: Clinical Trial\] aims to \[Primary Objective: evaluate the long-term efficacy and safety of robotic gastrectomy for locally advanced gastric cancer\] in \[Participant Population: patients with locally advanced gastric cancer, aged \>18 years and \<75 years\]. The primary questions it seeks to answer are:
Is the 3-year disease-free survival rate of robotic gastrectomy non-inferior to that of laparoscopic gastrectomy? Is the perioperative safety of robotic gastrectomy superior to that of laparoscopic gastrectomy? Researchers will compare \[Intervention Groups: Robotic Gastrectomy vs. Laparoscopic Gastrectomy\] to determine whether \[robotic surgery offers advantages in long-term efficacy and perioperative safety\].
Participants will:
Sign an informed consent form and be randomly assigned to either the robotic surgery group or the laparoscopic surgery group.
Undergo the assigned surgical procedure and receive regular follow-up visits (at 30 days, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 2 years, 2.5 years, and 3 years postoperatively).
Complete physical examinations, blood tests (including complete blood count, biochemical markers, and tumor markers), and imaging studies (such as abdominal CT, upper gastrointestinal endoscopy, and chest X-ray) during the follow-up period.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Age \> 18 years and \< 75 years.
✓. 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.
✓. Preoperative clinical staging as locally advanced gastric cancer (cT2-4a, N0-3, M0) according to the 8th edition of the AJCC TNM staging system.
✓. No distant metastasis on preoperative examination, and no direct invasion of the pancreas, spleen, or other adjacent organs.
✓. Preoperative ECOG performance status score of 0 or 1.
✓. Preoperative ASA (American Society of Anesthesiologists) physical status score of I-III.
✓. Consent to participate in the study and signing of the informed consent form.
Exclusion criteria
✕. Previous history of gastric malignancy surgery, including submucosal resection and/or endoscopic mucosal resection.