Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-29 @ 9:54 PM
Study NCT ID:
NCT05782556
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2023-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Freiburg TIPS Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D006975', 'term': 'Hypertension, Portal'}, {'id': 'D006502', 'term': 'Budd-Chiari Syndrome'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020246', 'term': 'Venous Thrombosis'}, {'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum, plasma, peripheral blood mononuclear cell (PBMC)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2034-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-07', 'studyFirstSubmitDate': '2023-03-10', 'studyFirstSubmitQcDate': '2023-03-22', 'lastUpdatePostDateStruct': {'date': '2024-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2033-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Transplantation-free survival', 'timeFrame': '01/01/2023-31/12/2033', 'description': 'Time from study inclusion to death or liver transplantation'}], 'secondaryOutcomes': [{'measure': 'Time to development of post-TIPS hepatic encephalopathy', 'timeFrame': '01/01/2023-31/12/2033', 'description': 'Time from study inclusion to development of post-TIPS hepatic encephalopathy'}, {'measure': 'Time to development of post-TIPS acute- on chronic liver failure (ACLF)', 'timeFrame': '01/01/2023-31/12/2033', 'description': 'Time from study inclusion to development of post-TIPS ACLF'}, {'measure': 'Time to need for TIPS revision', 'timeFrame': '01/01/2023-31/12/2033', 'description': 'Time from study inclusion to need for TIPS revision'}, {'measure': 'Prevalence of osteoporosis in patients with TIPS implantation', 'timeFrame': '01/01/2023-31/12/2033', 'description': 'Osteoporosis is assessed by DXA measurement'}, {'measure': 'Impact of osteoporosis on prognosis and decompensating events after TIPS', 'timeFrame': '01/01/2023-31/12/2033', 'description': 'Osteoporosis is assessed by DXA measurement. Bone density will be correlated with prognosis and decompensating events.'}, {'measure': 'Prevalence of sarcopenia in patients with TIPS implantation', 'timeFrame': '01/01/2023-31/12/2033', 'description': 'Sarcopenia is assessed by computed tomography.'}, {'measure': 'Impact of sarcopenia on prognosis and decompensating events after TIPS', 'timeFrame': '01/01/2023-31/12/2033', 'description': 'Sarcopenia is assessed by computed tomography and is correlated with prognosis and the development of decompensating events after TIPS'}, {'measure': 'Time to development of post-TIPS infections/sepsis', 'timeFrame': '01/01/2023-31/12/2033', 'description': 'Time from study inclusion to development of post-TIPS infections/sepsis'}, {'measure': 'Periinterventional complications', 'timeFrame': '01/01/2023-31/12/2033', 'description': 'Periinterventional complications (infections, bleeding, biliary injury) are assessed during the intervention. These complications are documented in the report of the intervention and are assessed systematically.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Liver cirhosis', 'Transjugular intrahepatic portosystemic shunt', 'Non-Cirrhotic Portal Hypertension', 'Prognosis', 'Outcome'], 'conditions': ['Liver Cirrhosis', 'Portal Hypertension', 'Non-Cirrhotic Portal Hypertension', 'Budd Chiari Syndrome', 'Portal Vein Thrombosis', 'Portal Systemic Shunt']}, 'referencesModule': {'references': [{'pmid': '41204773', 'type': 'DERIVED', 'citation': 'Heger LA, Chang J, Rohrer C, Reincke M, Eyth A, Sturm L, Schultheiss M, Maier A, Meyer C, Jansen C, Graf K, Ozturk C, Schneider F, Trebicka J, Westermann D, Thimme R, Grundmann S, Praktiknjo M, Bettinger D. Right Ventricular Contractility Predicts Clearance of Ascites After Transjugular Intrahepatic Portosystemic Shunt. Liver Int. 2025 Dec;45(12):e70422. doi: 10.1111/liv.70422.'}], 'seeAlsoLinks': [{'url': 'http://www.uniklinik-freiburg.de/medizin2/forschung/klinische-forschung/ag-schultheissbettinger.html', 'label': 'Homepage Interventional Hepatology University Medical Center Freiburg'}]}, 'descriptionModule': {'briefSummary': 'Patients with clinically significant portal hypertension allocated to implantation of a transjugular intrahepatic portosystemic shunt (TIPS) at the Department of Medicine II of the University Medical Center Freiburg, Germany will be offered to participate in this prospective observational trial.\n\nClinical and laboratory as well as outcome parameters will be assessed before and within the first 12 months after TIPS implantation following a regular follow-up schedule with clinical visits at the University Medical Center Freiburg. During follow-up visits, serum/plasma samples and peripheral blood mononuclear cells (PBMC) are collected and stored in a associated biobank.', 'detailedDescription': 'Patients with clinically significant cirrhotic and non-cirrhotic portal hypertension who are allocated to implantation of a transjugular intrahepatic portosystemic shunt (TIPS) can be included in this observational study. Further patients who have been treated between 01/01/2005 and the start of the prospective part of this study (01/01/2023) will be included retrospectively in this registry.\n\nPatients who are allocated to TIPS implantation will be recruited the day before TIPS implantation. Detailled patient characteristics, epidemiologic, clinical, imaging and laboratory parameters will be assessed and included in an electronic database. Further, interventional data of TIPS implantation will be included in the database.\n\nApart from these data, patients will be asked to participate in biobank sampling including serum/plasma and peripheral blood mononuclear cells (PBMC) samples from the peripheral veins and from the liver and portal vein that will be taken during TIPS implantation.\n\nAll patients recruited in this registry will be followed-up for at least 12 months with regular visits 3, 6 and 12 months after TIPS implantation.\n\nOutcome parameters including development of post-TIPS hepatic encephalopathy, acute- on chronic liver failure (ACLF), infections, recurrence of clinically significant portal hypertension, need for TIPS revision and death and liver transplantation will be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients allocated to TIPS implantation due to clinically significant cirrhotic and non-cirrhotic portal hypertension will be included in this study.In summary, patients with the folowing conditions can be included:\n\n* liver cirrhosis and indication for TIPS implantation (pre-emptive TIPS or rescue TIPS in case of varical bleeding, secondary prophylaxis of varical bleeding, recurrent or refractory ascites, TIPS before surgery)\n* non-cirrhotic portal vein thrombosis\n* Budd-Chiari syndrome\n* porto-sinusoidal vascular disease', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients allocated to TIPS implantation due to clinically significant cirrhotic and non-cirrhotic portal hypertension\n\nExclusion Criteria:\n\n* Withdrawal of written informed consent'}, 'identificationModule': {'nctId': 'NCT05782556', 'acronym': 'FRETIR', 'briefTitle': 'Freiburg TIPS Registry', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Freiburg'}, 'officialTitle': 'Transjugular Intrahepatic Portosystemic Shunt (TIPS) for the Treatment of Portal Hypertension: an Observational Study', 'orgStudyIdInfo': {'id': 'FRETIR01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients allocated to implantation of a transjugular intrahepatic portosystemic shunt (TIPS)', 'description': 'Patients allocated to implantation of a transjugular intrahepatic portosystemic shunt (TIPS) due to cirrhotic and non-cirrhotic portal hypertension', 'interventionNames': ['Device: Implantation of a transjugular intrahepatic portosystemic shunt (TIPS)']}], 'interventions': [{'name': 'Implantation of a transjugular intrahepatic portosystemic shunt (TIPS)', 'type': 'DEVICE', 'description': 'For TIPS implantation, a transjugular approach is used in all patients and a puncture needle was advanced into a hepatic vein. Puncture of the portal vein is performed using ultrasound guidance followed by portography after successful puncture of the portal vein. Further, the parenchymal tract isdilated and the stent graft is placed. Before and after TIPS implantation, portal venous and central venous pressures are measured to calculate the porto-systemic pressure gradient', 'armGroupLabels': ['Patients allocated to implantation of a transjugular intrahepatic portosystemic shunt (TIPS)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '79106', 'city': 'Freiburg im Breisgau', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Dominik Bettinger, MD', 'role': 'CONTACT', 'email': 'dominik.bettinger@uniklinik-freiburg.de', 'phone': '49761270-36870'}, {'name': 'Dominik Bettinger, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Michael Schultheiß, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Lukas Sturm, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Marlene Reincke, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Medical Center Freiburg, Department of Medicine II', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}], 'centralContacts': [{'name': 'Dominik Bettinger, MD', 'role': 'CONTACT', 'email': 'dominik.bettinger@uniklinik-freiburg.de', 'phone': '49761270-36870'}], 'overallOfficials': [{'name': 'Dominik Bettinger, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Freiburg'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Freiburg', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'PD Dr. Dominik Bettinger', 'investigatorAffiliation': 'University Hospital Freiburg'}}}}