Liver Transplantation in Patients With Incidental Hepatocellular-cholangiocarcinoma and Intrahepatic Cholangiocarcinoma: A Single-center Experience

• Conditions: Adult Combined Hepatocellular-Cholangiocarcinoma
• Interventions: Procedure: liver transplantation

• Registration Number: NCT04848805
• Lead Sponsor: Istanbul Demiroglu Bilim University

Brief Summary

Liver transplantation has become an important treatment in hepatocellular cancer (HCC). While the generally determined malign indication in the world is HCC, some centers perform liver transplantation in both cholangiocarcinoma and mixed type hepatocellular-cholangiocarcinoma diseases and investigate the differences in recurrence and survival outcomes compared to HCC. Although liver transplantation for intrahepatic cholangiocarcinomas of small diameter \<2cm is a popular topic of discussion around the world, a common consensus has not been established.

Detailed Description

Combined hepatocellular and cholangiocarcinoma (CHC) with an incidence rate from 0.4% to 14.2% in different regions, characterized by hepatocellular and biliary epithelial differentiation within the same tumor, is an unique type of primary hepatic carcinoma that is distinct from hepatocellular carcinoma (HCC) and intrahepatic cholangiocarcinoma (ICC). Combined hepatocellular and cholangiocarcinoma is having attention clinically and pathologically, because of its unique biology, histopathology, and clinical behavior, besides the difficulties in diagnosis and being rare (comprising 1-5% of primary liver cancer). The investigators aimed to present our experience with patients misdiagnosed before LT and found to have incidentally ICC or CHC on explant and compare with HCC, and to identify the demographic, clinical, pathological and etiological risk factors of recurrence and prognostic factors of survival. Liver transplantation has been tried as an effective treatment in mixed-type hepatocellular-cholangiocarcinomas and intrahepatic cholangiocarcinomas, but survival and recurrence-free outcomes have not been achieved as well as HCC. In addition, survival rates reported in different centers also vary. Prognostic factors that may affect disease recurrence and survival include etiology, body mass index, AFP, CEA, CA 19-9, CK7, CK19, CD34, CD56, CD117, CD133, HSA, Arginase, HEPPAR, Amacyr, Glypican 3, Synaptophysin, CK20, CDX2, p53, Ki67, milan criteria, tumor size, tumor number, maximum tumor diameter, total tumor diameter, tumor grade, multicentricity, microvascular invasion, macrovascular invasion, vascular invasion, tumor TNM stage. İnvestigating whether there is a difference between mixed type hepatocellular-cholangiocarcinomas compared to HCC in terms of survival, recurrence and other prognostic markers mentioned above would be important for mixed type tumor relations with liver transplantation.

Study Timeline

• Study Start: 2020-03-01
• Primary Completion: 2021-02-01
• Study First Submitted: 2021-04-02
• Study First Submitted QC: 2021-04-16
• Study First Posted: 2021-04-19
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-26
• Last Update Posted: 2022-03-02
• Study Completion: 2022-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 279

Inclusion Criteria

1. Explant pathology Being Combined Hepatocellular-Cholangiocarcinoma and Intrahepatic Cholangiocarcinoma
2. Having a liver transplant
3. Being over 18 years old

Exclusion Criteria

1. Explant pathology being hepatocellular carcinoma
2. Being under the age of 18

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
liver recipients with hepatocellular and cohlangiocarcinoma diagnosis	liver transplantation	liver recipients

Primary Outcome Measures

Name	Time	Method
recurrence	2005-2020	correlation between tumor diameter, milan criteria and recurrence

Trial Locations

Locations (1)

Group Florence Nightingale Hospitals; 🇹🇷 Istanbul, Turkey