NCT04848805

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
279

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 19, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

March 2, 2022

Status Verified

February 1, 2022

Enrollment Period

11 months

First QC Date

April 2, 2021

Last Update Submit

February 26, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • recurrence

    correlation between tumor diameter, milan criteria and recurrence

    2005-2020

Study Arms (1)

liver recipients with hepatocellular and cohlangiocarcinoma diagnosis

liver recipients

Procedure: liver transplantation

Interventions

total hepatectomy material was examined by pathology laboratory

liver recipients with hepatocellular and cohlangiocarcinoma diagnosis

Eligibility Criteria

Age18 Years - 78 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Explant pathology Being Combined Hepatocellular-Cholangiocarcinoma and Intrahepatic Cholangiocarcinoma
  • Having a liver transplant
  • Being over 18 years old

You may not qualify if:

  • Explant pathology being hepatocellular carcinoma
  • Being under the age of 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Group Florence Nightingale Hospitals

Istanbul, 34349, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Liver Transplantation

Intervention Hierarchy (Ancestors)

Tissue TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsDigestive System Surgical ProceduresSurgical Procedures, OperativeOrgan TransplantationTransplantation

Central Study Contacts

Ender Anılır, M.D.

CONTACT

Yıldıray Yüzer, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2021

First Posted

April 19, 2021

Study Start

March 1, 2020

Primary Completion

February 1, 2021

Study Completion

May 1, 2022

Last Updated

March 2, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

No plan

Locations