Strategic International Session3(JSGS・JSGE・JSH)
Sat. November 4th   9:00 - 11:30   Room 9: Portopia Hotel Main Building Kairaku 3
A multicenter, prospective study to evaluate the safety and efficacy of living donor liver transplantation for unresectable perihilar cholangiocarcinoma
Taizo Hibi
Department of Pediatric Surgery and Transplantation, Kumamoto University Graduate School of Medical Sciences
Background and aim: Even among the most experienced centers, perihilar cholangiocarcinoma (phCCA) often becomes unresectable in patients with poor hepatic reserve, inadequate future liver remnant, extensive local vascular/biliary invasion, and in the presence of underlying primary sclerosing cholangitis. This study was aimed to evaluate the safety and efficacy of living donor liver transplantation (LDLT) in a multidisciplinary perspective to provide cure for unresectable phCCA under the concept of transplant oncology.
Patients and Methods: This is a phase I/II multicenter, prospective, single-arm interventional study and was approved and announced by the Ministry of Health, Labour and Welfare, Japan in September 2022. Ten high-volume LDLT centers are supposed to recruit 20 participants across Japan. The primary endpoint is 3-year overall survival. Pretransplant drop-out rate is estimated around 30%-40% based on the results of the Mayo Clinic series; therefore, we presume at least 12 patients with unresectable pCCA would undergo LDLT. Of these, if 5 patients or more survive for 3 years, the rate will exceed 42% (95% confidence interval: 0.16-0.73), which is equivalent to that after LDLT at Mayo Clinic (3-year survival, 40%-50% range). The 3-year survival rate of non-LDLT (drop-out) patients is expected to be around 10%. If the primary endpoint is met, we can confirm that LDLT provides prolonged survival for unresectable phCCA (significance level, 5%; statistical power, 81%).
Index Term 1: living donor liver transplantation
Index Term 2: perihilar cholangiocarcinoma
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