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

February 26, 2022 updated by: Istanbul Demiroglu Bilim University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

279

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
      • Istanbul, Turkey, 34349
        • Recruiting
        • Group Florence Nightingale Hospitals
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Collected LT database was retrospectively reviewed. 277 patients underwent LT for a primary liver tumor between September 2004 and November 2019 were included in the study. Among these, 17 patients (5%) with incidentally detected CHC and 5 patients (1.8%) with ICCA were included in the study. 257 HCC patients were determined as the control group.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
liver recipients with hepatocellular and cohlangiocarcinoma diagnosis
liver recipients
Procedure: liver transplantation
total hepatectomy material was examined by pathology laboratory

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
recurrence
Time Frame: 2005-2020
correlation between tumor diameter, milan criteria and recurrence
2005-2020

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Demiroglu Bilim University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2020

Primary Completion (Actual)

February 1, 2021

Study Completion (Anticipated)

May 1, 2022

Study Registration Dates

First Submitted

April 2, 2021

First Submitted That Met QC Criteria

April 16, 2021

First Posted (Actual)

April 19, 2021

Study Record Updates

Last Update Posted (Actual)

March 2, 2022

Last Update Submitted That Met QC Criteria

February 26, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-243

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

No plan

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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