Patients diagnosed by contrast-enhanced CT or MRI with primary liver cancer, metastatic liver cancer, perihilar cholangiocarcinoma, intrahepatic cholangiocarcinoma, gallbladder cancer, or benign tumors such as hemangioma, for whom liver resection, as well as bile duct resection and biliary reconstruction, is deemed necessary.
Conditions
Interventions
This clinical trial aims to evaluate the safety of robotic-assisted anatomic hepatectomy, including bile duct resection and biliary reconstruction. For the eligible disease, surgery will be performed
Sponsors
Keio University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients diagnosed by contrast-enhanced CT, MRI, or similar imaging modalities with primary liver cancer, metastatic liver cancer, perihilar cholangiocarcinoma, intrahepatic cholangiocarcinoma, gallbladder cancer, or benign tumors such as hemangioma. 2) Patients for whom liver resection, as well as bile duct resection and biliary reconstruction, is deemed necessary. 3) Age 18 years or older at the time of consent. 4) Written informed consent to participate in this clinical trial has been obtained from the patient. 5) ECOG performance status of 0 or 1.
Exclusion criteria
Exclusion criteria: 1) Patients with a history of myocardial infarction within the past 6 months or with unstable angina. 2) Patients with alcohol or drug dependence. 3) Pregnant or breastfeeding women, or women with potential for pregnancy. 4) Patients with respiratory diseases requiring continuous oxygen therapy. 5) Patients judged by anesthesiology to be unfit for general anesthesia. 6) Patients with synchronous multiple primary cancers. 7) Patients requiring vascular resection and reconstruction. 8) Patients judged to be at high surgical risk due to uncontrolled diabetes, long-term steroid use, cardiovascular risk, bleeding tendency, or other relevant conditions. 9) Any other patients deemed inappropriate for participation by the principal investigator or sub-investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All intraoperative and postoperative complications of Clavien-Dindo grade 3 or higher | — |
Countries
Japan
Contacts
Public ContactYuta Abe
Keio University School of Medicine Department of Surgery
Outcome results
None listed