臨床研究等提出・公開システム

A study of short-term surgical outcome of robot-assisted pancreatic surg
ery using da VINCI surgical system for pancreatobiliary disease at the ind
uction stage. -single center, single-arm, open-label, exploratory clinical st
udy-

Short-term surgical outcome of robot-assisted pancreatic surgery using
da VINCI surgical system for pancreatobiliary disease at the induction sta
ge.

Ryota Higuchi

Tokyo Women's Medical University Yachiyo Medical Center, Division of Gastroenterological Surgery

477-96 Owadashinden, Yachiyo City, Chiba

higuchi.ryota@twmu.ac.jp

Ryota Higuchi

Tokyo Women's Medical University Yachiyo Medical Center

477-96 Owadashinden, Yachiyo City, Chiba, 276-0046

+81-47-450-6000

higuchi.ryota@twmu.ac.jp

Recruiting

Aug. 01, 2020

Interventional

single arm study

open(masking not used)

historical control

single assignment

treatment purpose

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

Both

pancreaic disease, biliary disease

Robot-assisted pancreatic surgery (DA VINCI)

Pancreatic Diseases, Biliary Tract Diseases

Robotic Surgical Procedures

D010182, D001660

D065287

Grade 3 or higher complication rate of Clavien-Dindo classification

1. Overall complication rate of Clavien-Dindo classification
2. Intraoperative adverse events
3. Completion rate of robot-assisted surgery
4. Surgery time and intraoperative bleeding
5. R0 resection rate
6. Number of dissected lymph nodes

+81-3-3202-7181

Jan. 17, 2023

No

none