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Introduction In-vivo fluorescence imaging techniques using indocyanine green (ICG) to identify liver tumours and hepatic segment boundaries have been recently developed. The purpose of this study is to evaluate the efficacy of fusion ICG-fluorescence imaging for navigation during hepatectomy.Methods and analysis This will be an exploratory single-arm clinical trial; patients with liver tumours will undergo hepatectomy using the ICG-fluorescence imaging system. In total, 110 patients with liver tumours scheduled for elective hepatectomy will be included in this study. Preoperatively, ICG will be intravenously injected at a dose of 0.5 mg/kg body weight within 2 days. To detect liver tumours intraoperatively, the hepatic surface will be initially observed using the ICG-fluorescence imaging system. After identifying and clamping the portal pedicle corresponding to the hepatic segments, including the liver tumours to be resected, additional ICG will be injected intravenously at a dose of 0.5 mg/kg body weight to identify the boundaries of the hepatic segments. The primary outcome measure will be the success or failure of the ICG-fluorescence imaging system in identifying hepatic segments. The secondary outcomes will be the success or failure in identifying liver tumours, liver function indicators, operative time, blood loss, rate of postoperative complications and recurrence-free survival. The findings obtained through this study are expected to help to establish the utility of ICG-fluorescence imaging systems, and therefore contribute to prognostic outcome improvements in patients undergoing hepatectomy for various causes.Ethics and dissemination The protocol has been approved by the Kobe University Clinical Research Ethical Committee. The findings of this study will be disseminated widely through peer-reviewed publications and conference presentations.Trial registration number UMIN000031054 and jRCT1051180070

Introduction Multimodal treatment prolongs the survival of patients with biliary tract cancer (BTC). However, the chemotherapy choices for this disease are few, and completing each chemotherapy session is important. Adjuvant chemotherapy has been attempted for BTC, but has only had a 75% completion rate. Body weight loss and cholangitis are reasons for the interruption of chemotherapy. Previous reports suggested that nutritional intervention with omega-3 fatty acids maintained body weight and improved the completion rate for chemotherapy. Moreover, omega-3 fatty acids have an anti-inflammatory effect. Therefore, we theorised that omega-3 fatty acids would improve the completion rate of adjuvant chemotherapy in patients with BTC. The aim of this study is thus to evaluate the effectiveness of omega-3 fatty acids for patients planning adjuvant chemotherapy for BTC.Method and analysis This study is a single-centre, open-label, single-arm, historically controlled study with a planned enrolment of 55 participants. Protocol treatment consists of four courses of S-1 adjuvant chemotherapy and an oral omega-3 fatty acid pharmaceutic adjuvant (LOTRIGA 2 g (Takeda Pharmaceutical Co.)), which includes 2 g of omega-3 fatty acids from day 1 until day 168 of the treatment period. The primary endpoint is the completion rate of four total courses of S-1. Secondary endpoints are postoperative cholangitis, time to recurrence or distant metastasis, changes in nutritional index, changes in the lymphocyte blast transformation test induced by phytohaemagglutinin, and concanavalin A and diamine oxidase serum activity during adjuvant chemotherapy. All adverse events will be evaluated.Ethics and dissemination This protocol was approved by the Institutional Review Board of Kobe University Hospital. The findings from this study will be presented at national and international conferences and published in peer-reviewed journals.Trial registration number UMIN000031247.

Introduction Bile leak is still a major complication after liver resection to be improved. To intraoperatively detect this adverse complication, leak test is commonly performed after hepatic resection. However, by the conventional leak test, it is often difficult to know whether the test reagent reaches to intrahepatic bile duct near cut surface of liver with adequate volume and pressure to identify the existence of bile leak. Thus, in order to perform leak test more accurately, this study aims to evaluate the efficacy and safety of the leak test using contrast-enhanced intraoperative ultrasonic cholangiography (CE-IOUSC), which was reported by our group as a procedure for detection of bile duct. Methods and analysis The current study is a nonrandomised, prospective, off-label, single-arm clinical trial for patients who undergo liver resection. A total of 100 patients will be enrolled. After completion of liver resection, the leak test is performed with CE-IOUSC using Sonazoid as a contrast agent to visualise dye injection into the intrahepatic bile duct. The primary endpoint is the success of the leak test, defined as clear visualisation of intrahepatic bile duct around cut surface by ultrasonography that indicates enough volume of dye injection. Secondary endpoints are postoperative bile leak and all adverse events related to CEIOUSC. The findings obtained through this study will establish this procedure to assist surgeons for adequately performing the leak test, precisely detecting intraoperative biliary leak strictly and reducing postoperative bile leak. Ethics and dissemination The protocol is approved by Institutional Review Boards of Kobe University Hospital (No.290069). Our findings will be widely disseminated through conference presentations and peer-reviewed publications. [ABSTRACT FROM AUTHOR]