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

Adult Combined Hepatocellular-Cholangiocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04848805
• Other study ID #: 2020-243
• Status: Recruiting
• Start date: March 1, 2020
• Est. completion date: May 1, 2022

Study information

• Verified date: February 2022
• Source: Istanbul Demiroglu Bilim University
• Contact: Ender Anilir, M.D.
• Phone: 0905065025460
• Email: dr.enderanilir[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 279
• Est. completion date: May 1, 2022
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 78 Years

Eligibility

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

Related Conditions & MeSH terms

• Adult Combined Hepatocellular-Cholangiocarcinoma
• Cholangiocarcinoma

Intervention

Procedure:
• liver transplantation
total hepatectomy material was examined by pathology laboratory

Locations

Country	Name	City	State
Turkey	Group Florence Nightingale Hospitals	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Demiroglu Bilim University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recurrence	correlation between tumor diameter, milan criteria and recurrence	2005-2020