Prospective Observational Clinical Study to Prove Safety and Effectiveness When Applying RUS™ Surgical Navigation, Endoscopic Imaging Treatment Planning Software, in Gastric Cancer Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Pre-trocar insertion function accuracy
研究概览
简要总结
By uploading pre-operative patient information and patient CT data to RUS™, a virtual surgical environment with patient-specific relief prediction models can be provided. First, after uploading the CT and clinical information of a gastric cancer patient diagnosed with gastric cancer through an actual endoscopic biopsy and scheduled for robotic total gastrectomy, RUS™ will operate normally to check whether patient-specific surgical navigation is available before or during surgery. In particular, when using the patient-specific surgery simulation system provided by RUS™, the CT information provides a patient-specific 3D environment well, so it will be checked regarding whether the surgeon can use it before or during surgery without any particular problems. Using RUS™ software, navigation information is used before or during surgery, and among these, parts that can be quantitatively compared with actual measurements will be evaluated as a secondary research goal. After the surgery, the investigators plan to check the amount of bleeding, duration of hospitalization, and the rate of complications by performing robot gastrointestinal resection using the navigation system to ensure that there are no problems with patient safety.
详细描述
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Obtain consent from a patient who is diagnosed with gastric cancer and is scheduled for robotic surgery.
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Take an abdominal CT before gastric cancer surgery according to the prescribed protocol.
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Upload patient information and CT information before surgery to RUS™, an endoscopic treatment image planning software, to build a 3D modeling navigation system for a patient-customized surgical environment. (Measure the time (in days) from the time the CT is uploaded to the time when the RUS™ software can be operated.)
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Before surgery, use the RUS™ navigation system to check the patient's relief and anatomical structure, mark the planned trocar insertion site, and obtain distance information from the umbilical trocar.
⑤ After general anesthesia on the day of surgery, mark the Landmark 25 area on the abdominal wall using a surgical marking pen. In addition, the abdominal wall surface scan is performed using a laser 3D scanner.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Among the subjects, the subjects are selected according to the following criteria:
- •Those who have been diagnosed with gastric cancer and are scheduled for robotic total gastrectomy;
- •A person who is 18 years of age or older and able to make independent judgment on their own;
- •A person who can have a CT scan according to the established protocol;
- •Before participating in the clinical trial, an interview was conducted in an independent space, the purpose and contents of the clinical trial were fully explained, and the consent to participate in this study was voluntarily given (approved by the institutional research ethics review committee) and those who signed.
- •For reference, internal employees and immediate family members can also participate in this study unless there is a special reason for exclusion.
排除标准
- •If any of the following exclusion criteria are met among the subjects, participants will be excluded from this clinical trial:
- •Vulnerable subjects (those who lack medical ability, or are illiterate, pregnant, newborns, minors (under 18), etc.);
- •Persons who cannot have a CT scan according to the prescribed protocol prior to gastric cancer surgery (contrast agent allergy, creatinine 1.5 times the normal maximum, claustrophobia, etc.);
- •Persons whose major artery/venous structure in the stomach or abdominal cavity has been altered due to previous surgery (due to gastric cancer or other abdominal surgery);
- •Persons with residual gastric cancer with a history of gastric surgery;
- •Persons who did not consent to this study or who withdrew consent.
结局指标
主要结局
Pre-trocar insertion function accuracy
时间窗: 1 week
When the virtual trocar is inserted into the relief model in RUS™, the position and distance information of the trocar is provided, and the accuracy is evaluated by comparing it with the insertion position of the real trocar.
Surgery time
时间窗: 1 day
When robotic total gastric resection is performed using RUS™ surgical navigation, the operation time (console time in the case of robotic surgery) is measured and compared with the past control group.
Complication rate
时间窗: 1 month
When robotic total gastric resection is performed using RUS™ surgical navigation, the patient's complication rate is checked and compared with the past control group.
CT turn around
时间窗: 1 week
After the subject's CT is uploaded to the RUS™ software and segmentation is started, it is evaluated whether the relief model is created, segmentation of organs and blood vessels, and 3D reconstruction are performed and uploaded within 3 days.
Patient-specific pneumoperitoneum model accuracy
时间窗: 1 month
The accuracy is evaluated by comparing the patient-specific relief prediction model presented by the RUS™ surgical navigation with the actual patient's relief model scan data.
Bleeding volume
时间窗: 1 day
When robotic total gastrectomy is performed using RUS™ surgical navigation, the amount of bleeding is measured and compared with the previous control group.
Distance of major blood vessels
时间窗: 1 week
By comparing the branching distance of major blood vessels in RUS™ (total 7 (LGEA, RGEA, LGA, RGA, LGEV, RGEV, LGV)) and the branching distance of major blood vessels during actual surgery, it is evaluated whether the accuracy is greater than 90%.
Major blood vessel presentation
时间窗: 1 week
Evaluate whether the major blood vessels (a total of 7 (LGEA, RGEA, LGA, RGA, LGEV, RGEV, LGV)) that must be checked in total gastrectomy are 100% 3D reconstructed on the RUS™ navigation system.
Hospital stay after surgery
时间窗: 1 month
When robotic total gastrectomy is performed using RUS™ surgical navigation, the patient's postoperative hospital stay is checked and compared with the past control group.
次要结局
未报告次要终点