Efficacy of RUS GA Surgical Navigation for Robot-assisted Distal Gastrectomy in Gastric Cancer Patients

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

This investigator-initiated, randomized superiority clinical trial aims to demonstrate the clinical effectiveness of RUS GA Surgical Navigation, an endoscopic imaging treatment planning software, in patients undergoing robotic-assisted distal gastric cancer surgery. The trial will compare the experimental group using RUS GA with a control group, aiming to show an 8.7% reduction in total surgery duration. The study will involve global multicenter patient recruitment and evaluate the clinical safety and feasibility of the software, which has been shown to be reliable in previous studies.

• Investigational Medical Device: RUS GA (Endoscopic Imaging Treatment Planning Software, E04010.01)
• Clinical Trial duration: 30 months from IRB approval -Target number of subjects: Total of 330 participants

Study Overview

• Status: Recruiting
• Conditions: Gastric Cancer
• Intervention / Treatment: Device: RUS GA; Procedure: standard treatment

Detailed Description

After selecting subjects and obtaining informed consent, randomization will be conducted. Robot-assisted gastrectomy will be performed using RUS GA or without software. Clinical significance will be evaluated through outpatient follow -ups for up to one month after discharge.

• Study Type: Interventional
• Enrollment (Estimated): 330
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: min ah cho, Prof.; Phone Number: 08-2-2228-2100; Email: nestrel@yuhs.ac

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Department of Surgery, Yonsei University College of Medicine
    • Contact: Min Ah Cho, Prof.; Phone Number: 02-2228-2100; Email: nestrel@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group A; Robot-assisted gastrectomy will be performed using RUS GA	Device: RUS GA; he RUS GA (Endoscopic Imaging Treatment Planning Software, E04010.01(2)) is an endoscopic imaging treatment planning software program. It creates a patient-specific simulation of the actual intra-abdominal surgical environment, allowing for the visualization of vascular structures and intra-abdominal organs during the surgical planning process and the operation. RUS GA utilizes preoperative CT images of the patient to segment organs and blood vessels and reconstructs them into a 3D model. Although there is no direct intervention with the patient, the surgeon uses RUS GA as a surgical navigation tool to simulate the surgery before performing the actual procedure.
Active Comparator: Active Comparator Group B (standard treatment); Robot-assisted gastrectomy will be performed using without software RUS GA. Only	Procedure: standard treatment; Only standard treatment is performed.(Robot-assisted gastrectomy will be performed using without software RUS GA.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgery duration	To assess whether the use of the endoscopic imaging treatment planning software, RUS GA, in actual surgeries of patients with gastric cancer results in a statistically significant reduction in total surgical time compared to surgeries conducted without the use of RUS GA.	during surgery(Record anesthesia time, total operation time, and robot console time separately)

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2024
• Primary Completion (Estimated): February 20, 2027
• Study Completion (Estimated): March 22, 2027

Study Registration Dates

• First Submitted: October 10, 2024
• First Submitted That Met QC Criteria: October 10, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): June 17, 2025
• Last Update Submitted That Met QC Criteria: June 15, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: 1-2024-0044

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No