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

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-

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1032200086
Enrollment
30
Registered
2020-08-17
Start date
2020-08-03
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pancreaic disease, biliary disease Pancreatic Diseases, Biliary Tract Diseases

Interventions

Robot-assisted pancreatic surgery (DA VINCI)
Robotic Surgical Procedures

Sponsors

Ryota Higuchi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Grade 3 or higher complication rate of Clavien-Dindo classification

Secondary

MeasureTime frame
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

Contacts

Public ContactHiguchi Ryota

Tokyo Women's Medical University Yachiyo Medical Center

higuchi.ryota@twmu.ac.jp+81-47-450-6000

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026