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

Phase 1

Recruiting

• Conditions: pancreaic disease, biliary disease; Pancreatic Diseases, Biliary Tract Diseases; D010182, D001660

• Registration Number: JPRN-jRCT1032200086
• Lead Sponsor: Ryota Higuchi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-08-17
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Grade 3 or higher complication rate of Clavien-Dindo classification

Secondary Outcome Measures

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