A study of short-term surgical outcome of robot-assisted pancreatic surgery using da VINCI surgical system for pancreatobiliary disease at the induction stage. -single center, single-arm, open-label, exploratory clinical study

Ryota Higuchi0 个研究点目标入组 30 人开始时间: 2020年8月17日最近更新: 2023年10月17日

适应症

试验速览

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•1. Patients 20 years old or older and 85 years old or younger at the time of obtaining consent
•2. Patients with pancreatobiliary disease in indications for which robot-assisted surgery is approved in insurance medical care,
•3. The general condition is evaluated before surgery, and it is diagnosed that pancreatectomy under general anesthesia is possible
•4. Performance Status (ECOG) is 0 or 1
•5. Fulfill the following conditions (leukocyte count more than 3,000 /mm3, platelet count more than
•100,000 /mm3, AST less than 150 IU /L, ALT less than 150 IU/L, total bilirubin less than 3.0 g/dl, se
•rum creatinine less than 1.5 mg/dl, based on laboratory data within 56 days before registration)
•6. Patients who have given their own voluntary informed consent with sufficient explanation and understanding

•1. High degree of adhesion is predicted due to intraperitoneal surgery for other diseases
•2. There may be pregnant or during breastfeeding
•3. it is judged that it is difficult to participate in clinical research by mental disease
•4. Receiving continuous long-term administration of steroids (oral or intravenous)
•5. History of myocardial infarction within 6 months or unstable angina pectoris
•6. Complicated with uncontrolled hypertension
•7. Complicated with uncontrolled diabetes
•8. Complicated respiratory disease requiring continuous oxygen administration
•9. Other patients judged by the investigator to be inappropriate as subjects

发起方

Ryota Higuchi