NCT06791538Recruiting
Robotic Versus Laparoscopic Radical Surgery for Locally Advanced Gastric Cancer
A Multicenter, Prospective, Randomized Controlled Clinical Study of Robotic Versus Laparoscopic Radical Surgery for Locally Advanced Gastric Cancer
Source: ClinicalTrials.gov · Last updated 8 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 740 (estimated)
- First submitted
- 19 Jan 2025
- Start date
- 1 Feb 2025
- Primary completion date
- 1 Feb 2027
- Lead sponsor
- Southwest Hospital, China
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT06791538
What you commit to
- Study type: Interventional
- Planned participants: 740
- From 1 Feb 2025 to the primary completion date, 1 Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous history of gastric malignancy surgery, including submucosal resection and/or endoscopic mucosal resection.
- Systemic corticosteroid therapy within 1 month prior to the study.
- Need for concurrent surgery for other diseases.
Other illness
- History of upper abdominal surgery (excluding laparoscopic cholecystectomy).
- Patient underwent emergency surgery due to gastric tumor bleeding or perforation.
- History of other malignancies, or presence of other malignant tumors detected during preoperative examination.
- Patient has a history of malignant tumor, or other malignant tumors were found during preoperative examination
- Severe psychiatric disorders.
- History of unstable angina or myocardial infarction within the past 6 months.
- History of cerebral infarction or cerebral hemorrhage within the past 6 months.
- Severe pulmonary disease with FEV1 \< 50%.
Other
- Preoperative imaging shows regional lymph nodes with confluent enlargement (maximum diameter ≥3cm).
- ASA (American Society of Anesthesiologists) score \>3.
- Pregnant or breastfeeding women.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Southwest hospital of AMU Coordinator of this site? Confirm its status | Chongqing | China | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.