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

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

NCT ID: NCT06639490

Condition: Gastric Cancer

Conditions: Official terms:
Stomach Neoplasms

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Device
Intervention name: RUS GA
Description: 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.
Arm group label: Experimental Group A

Intervention type: Procedure
Intervention name: standard treatment
Description: Only standard treatment is performed.(Robot-assisted gastrectomy will be performed using without software RUS GA.)
Arm group label: Active Comparator Group B (standard treatment)

Summary: 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

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.

Criteria for 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.

Gender: All

Minimum age: 20 Years

Maximum age: 90 Years

Healthy volunteers: No

Start date: November 1, 2024

Completion date: March 22, 2027

Lead sponsor:
Agency: Yonsei University
Agency class: Other

Source: Yonsei University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06639490