Adult Combined Hepatocellular-CholangiocarcinomaNCT04848805
Liver Transplantation in Patients With Incidental Hepatocellular-cholangiocarcinoma and Intrahepatic Cholangiocarcinoma: A Single-center Experience
An observational study of Adult Combined Hepatocellular-Cholangiocarcinoma, run by Istanbul Demiroglu Bilim University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 to 78 years
- Conditions the study is for
- Adult Combined Hepatocellular-Cholangiocarcinoma
- What is being tested?
- liver transplantation
- Type of treatment
- Surgery or procedure
- How many people
- 279 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2020to 1 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 78 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Explant pathology Being Combined Hepatocellular-Cholangiocarcinoma and Intrahepatic Cholangiocarcinoma
- Having a liver transplant
- Being over 18 years old
Who cannot join
- Explant pathology being hepatocellular carcinoma
- Being under the age of 18
Trial locations and contacts
1 site in 1 country.
Yıldıray Yüzer, Professor contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Group Florence Nightingale Hospitals
Istanbul, 34349
Ender Anılır, M.D., 0905065025460, dr.enderanilir@gmail.com
About this study
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.
Read the 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.
- Being tested
- liver transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liver transplantationProcedure or surgery
total hepatectomy material was examined by pathology laboratory
| Study group | Role | What they receive |
|---|---|---|
| liver recipients with hepatocellular and cohlangiocarcinoma diagnosis | liver recipients Receives: Procedure: liver transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence
correlation between tumor diameter, milan criteria and recurrence
Measured: 2005-2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start1 Mar 2020
- Primary completion1 Feb 2021
- Study completion1 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Combined Hepatocellular-CholangiocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 279 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Demiroglu Bilim University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04848805
- Sponsor's protocol ID
- 2020-243
- Status last verified
- Feb 2022
- First submitted
- 2 Apr 2021
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liver Transplantation in Patients With Incidental Hepatocellular-cholangiocarcinoma and Intrahepatic Cholangiocarcinoma: A Single-center Experience
- ClinicalTrials.gov ID
- NCT04848805
- Acronym / sponsor ID
- 2020-243
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 279 participants (estimated)
- Lead sponsor
- Istanbul Demiroglu Bilim UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 19 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| liver recipients with hepatocellular and cohlangiocarcinoma diagnosis | – | Procedure: liver transplantationliver recipients |
Who may qualify
- Ages
- 18 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Explant pathology Being Combined Hepatocellular-Cholangiocarcinoma and Intrahepatic Cholangiocarcinoma
- Having a liver transplant
- Being over 18 years old
Key exclusion criteria (2 listed)
- Explant pathology being hepatocellular carcinoma
- Being under the age of 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| liver transplantationtotal hepatectomy material was examined by pathology laboratory | Procedure or surgery | liver recipients with hepatocellular and cohlangiocarcinoma diagnosis |
Primary outcome
recurrence
Time frame: 2005-2020
correlation between tumor diameter, milan criteria and recurrence
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Individual participant dataSharing planned: No. No plan
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yıldıray Yüzer, Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adult Combined Hepatocellular-Cholangiocarcinoma, run by Istanbul Demiroglu Bilim University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ender Anılır, M.D. (0905065025460, dr.enderanilir@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrence (time frame: 2005-2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.