Clinical Trial: Evaluation of the safety of robotic-assisted anatomic hepatectomy, including bile duct resection and biliary reconstruction (Japan)

Tokyo, Sept. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058846) titled 'A study to evaluate the safety of robotic-assisted liver resection, including bile duct resection and biliary reconstruction' on Sept. 1.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Historical

Primary Sponsor: Institute - Keio University

Condition: Condition - 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. Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - The purpose of this clinical trial is to evaluate the safety of robotic-assisted anatomic hepatectomy, including bile duct resection and biliary reconstruction. Basic objectives2 - Safety

Intervention: Interventions/Control_1 - 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 using the da Vinci Xi system, and intraoperative and postoperative complications will be observed. If a patient is deemed eligible for this study, the principal investigator or sub-investigators will explain the study in the outpatient setting using an informed consent document approved by the Keio University School of Medicine Ethics Committee. The advantages and disadvantages of robotic-assisted surgery will be thoroughly explained, and sufficient time will be provided for the patient to consider whether they wish to undergo this protocol treatment. Preoperative assessment, including evaluation of liver function, will be performed. Postoperative management will continue until discharge, regardless of the presence or absence of complications, following standard surgical care. For each case, a Safety Evaluation Committee, including a board-certified hepatobiliary-pancreatic surgeon and an external physician recommended by the Japanese Society of Gastroenterological Surgery or the Japanese Society of Hepato-Biliary-Pancreatic Surgery, will review whether the clinical trial was conducted according to protocol. Additionally, the next patient will not be enrolled until the evaluation report for the previous case is completed.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key 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. Key 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. Target Size - 3

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 08 Month 18 Day Anticipated trial start date - 2025 Year 09 Month 01 Day Last follow-up date - 2029 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067273

Disclaimer: Curated by HT Syndication.