RUS GA surgical navigation for robot-assisted distal gastrectomy in gastric cancer

Efficacy of RUS GA Surgical Navigation for Robot-assisted Distal Gastrectomy in Gastric Cancer Patients: Global Multicenter Randomized Controlled Trial

This study will test whether RUS GA, an endoscopic imaging treatment-planning software, can shorten total operating time for adults having robot-assisted distal gastrectomy for gastric cancer.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 330 (estimated)
• Ages: 20 Years to 90 Years
• Sex: All
• Sponsor: Yonsei University (other)
• Locations: 1 site (Seoul)
• Trial ID: NCT06639490 on ClinicalTrials.gov

What this trial studies

This is a randomized, superiority trial comparing robot-assisted distal gastrectomy performed with RUS GA surgical navigation versus standard robot-assisted surgery without the software. The trial aims to show an 8.7% reduction in total surgery duration and will enroll about 330 participants across multiple global centers. After informed consent and preoperative CT imaging, participants are randomized and followed through one month after discharge to evaluate clinical safety and feasibility. Outcomes include total operative time and perioperative safety measures.

Who should consider this trial

Good fit: Adults aged 20 or older with diagnosed gastric cancer scheduled for robot-assisted distal gastrectomy who can undergo protocol CT imaging and provide informed consent.

Not a fit: Patients who cannot undergo the required CT imaging, are under 20 or otherwise classified as vulnerable, or who will not receive robot-assisted distal gastrectomy are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, the software could shorten surgery time, potentially reducing anesthesia exposure, improving recovery, and increasing operating-room efficiency.

How similar studies have performed: Previous studies have reported the RUS GA software to be reliable, but randomized evidence specifically showing reduced operative time is limited.

Eligibility criteria

Inclusion Criteria:

1. Individuals diagnosed with gastric cancer and scheduled for robot-assisted gastrectomy.
2. Adults aged 20 and above who are capable of independent judgment.
3. Individuals capable of undergoing CT imaging according to the prescribed protocol.
4. Individuals who, before participating in the clinical trial, undergo an interview in a separate place, understand sufficient explanation of the purpose and content of the trial, and voluntarily sign informed consent form (approved by the Institutional Review Board)

Exclusion Criteria:

1. Vulnerable individuals (those lacking decision-making capacity, illiterate individuals, pregnant women, newborns, minors under the age of 20, etc.).
2. Patients who cannot undergo CT imaging according to the prescribed protocol before gastric cancer surgery (due to contrast agent allergies, creatinine levels exceeding 1.5 times the normal upper limit, claustrophobia, etc.).
3. Individuals whose major gastric or intra-abdominal arterial/venous structures have been altered due to previous gastric or other abdominal surgeries (however, those with a history of intra-abdominal surgery that did not affect the stomach or major blood vessels are eligible).
4. Patients with a history of residual gastric cancer from previous surgery.
5. Patients who do not consent to participate in the study or withdraw their consent.
6. Patients scheduled for simultaneous resection of other organs besides the stomach.

Where this trial is running

Seoul

• Department of Surgery, Yonsei University College of Medicine — Seoul, South Korea (RECRUITING)

Study contacts

• Study coordinator: min ah cho, Prof.

Conditions: Gastric Cancer