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

NCT ID: NCT04848805

Last Updated: 2022-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

279 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-01

Study Completion Date

2022-05-01

Brief Summary

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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

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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.

Conditions

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Adult Combined Hepatocellular-Cholangiocarcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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liver recipients with hepatocellular and cohlangiocarcinoma diagnosis

liver recipients

liver transplantation

Intervention Type PROCEDURE

total hepatectomy material was examined by pathology laboratory

Interventions

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liver transplantation

total hepatectomy material was examined by pathology laboratory

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

78 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul Demiroglu Bilim University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Group Florence Nightingale Hospitals

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Ender Anılır, M.D.

Role: CONTACT

0905065025460

Yıldıray Yüzer, Professor

Role: CONTACT

Facility Contacts

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Ender Anılır, M.D.

Role: primary

0905065025460

Other Identifiers

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2020-243

Identifier Type: -

Identifier Source: org_study_id

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