Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2026-01-06 @ 4:42 PM
Study NCT ID:
NCT04848805
Status:
UNKNOWN
Last Update Posted:
2022-03-02
First Post:
2021-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Liver Transplantation in Patients With Incidental Hepatocellular-cholangiocarcinoma and Intrahepatic Cholangiocarcinoma: A Single-center Experience
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016031', 'term': 'Liver Transplantation'}], 'ancestors': [{'id': 'D016378', 'term': 'Tissue Transplantation'}, {'id': 'D064987', 'term': 'Cell- and Tissue-Based Therapy'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D016377', 'term': 'Organ Transplantation'}, {'id': 'D014180', 'term': 'Transplantation'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 279}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2022-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-26', 'studyFirstSubmitDate': '2021-04-02', 'studyFirstSubmitQcDate': '2021-04-16', 'lastUpdatePostDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'recurrence', 'timeFrame': '2005-2020', 'description': 'correlation between tumor diameter, milan criteria and recurrence'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Adult Combined Hepatocellular-Cholangiocarcinoma']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '78 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Explant pathology Being Combined Hepatocellular-Cholangiocarcinoma and Intrahepatic Cholangiocarcinoma\n2. Having a liver transplant\n3. Being over 18 years old\n\nExclusion Criteria:\n\n1. Explant pathology being hepatocellular carcinoma\n2. Being under the age of 18'}, 'identificationModule': {'nctId': 'NCT04848805', 'briefTitle': 'Liver Transplantation in Patients With Incidental Hepatocellular-cholangiocarcinoma and Intrahepatic Cholangiocarcinoma: A Single-center Experience', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul Demiroglu Bilim University'}, 'officialTitle': 'Liver Transplantation in Patients With Incidental Hepatocellular-cholangiocarcinoma and Intrahepatic Cholangiocarcinoma: A Single-center Experience', 'orgStudyIdInfo': {'id': '2020-243'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'liver recipients with hepatocellular and cohlangiocarcinoma diagnosis', 'description': 'liver recipients', 'interventionNames': ['Procedure: liver transplantation']}], 'interventions': [{'name': 'liver transplantation', 'type': 'PROCEDURE', 'description': 'total hepatectomy material was examined by pathology laboratory', 'armGroupLabels': ['liver recipients with hepatocellular and cohlangiocarcinoma diagnosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34349', 'city': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Ender Anılır, M.D.', 'role': 'CONTACT', 'email': 'dr.enderanilir@gmail.com', 'phone': '0905065025460'}], 'facility': 'Group Florence Nightingale Hospitals', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Ender Anılır, M.D.', 'role': 'CONTACT', 'email': 'dr.enderanilir@gmail.com', 'phone': '0905065025460'}, {'name': 'Yıldıray Yüzer, Professor', 'role': 'CONTACT', 'email': 'yildiray.yuzer@gmail.com'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No plan'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Demiroglu Bilim University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}