Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2026-01-01 @ 10:00 PM
Study NCT ID:
NCT05466669
Status:
UNKNOWN
Last Update Posted:
2022-07-20
First Post:
2022-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prediction of Post-TIPS Hepatic Encephalopathy in Patients With Liver Cirrhosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006501', 'term': 'Hepatic Encephalopathy'}, {'id': 'D008103', 'term': 'Liver Cirrhosis'}], 'ancestors': [{'id': 'D017093', 'term': 'Liver Failure'}, {'id': 'D048550', 'term': 'Hepatic Insufficiency'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D001928', 'term': 'Brain Diseases, Metabolic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Peripheral blood (EDTA, serum). Portal vein blood (EDTA, serum). Hepatic vein blood (EDTA, serum).'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 83}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2025-02-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-15', 'studyFirstSubmitDate': '2022-07-13', 'studyFirstSubmitQcDate': '2022-07-15', 'lastUpdatePostDateStruct': {'date': '2022-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prediction of post-TIPS HE using established tests', 'timeFrame': '12 months', 'description': 'Evaluation of the predictive value of S-ANT1 and Stroop EncephalApp compared with PHES (gold standard) for predicting post-TIPS HE within the first 12 months after TIPS implantation.'}], 'secondaryOutcomes': [{'measure': 'Evaluation of candidate inflammatory biomarkers (using the Olink target 96 panel) for predicting of post-TIPS HE', 'timeFrame': '12 months', 'description': 'Evaluation of exploratory candidate inflammatory biomarkers derived from peripheral blood and analyzed using the validated Olink target 96 panel for the prediction ofpost-TIPS HE.'}, {'measure': 'Evaluation of the impact of frailty, assessed by the Liver Frailty Index (LFI) on the risk of post-TIPS HE.', 'timeFrame': '12 months', 'description': 'The presence of frailty - using the validated LFI - will be assessed in each patient prior to TIPS implantation and 1, 3 and 6 months after TIPS implantation. The full range of the LFI is 1.0-7.0 (with a higher score indicating that the patient is more frail)'}, {'measure': 'Longitudinal assessment of health-related quality of life using the Chronic Liver Disease Questionnaire (CLDQ)', 'timeFrame': '12 months', 'description': 'Health-related quality will be assessed in each participant using the validated CLDQ. Quality of life will be assessed at baseline and 1-, 3- and 6- months post-TIPS implantation.'}, {'measure': 'Longitudinal assessment of cognitive function after TIPS insertion', 'timeFrame': '12 months', 'description': 'Assessment of longitudinal changes in PHES, Stroop EncephalApp and S-ANT1 after TIPS implantation. The tests will be applied to all patients at baseline and at 1-, 3- and 6- months post-TIPS implantation.'}, {'measure': 'Evaluation of serum Neurofilament Light Chains (sNfL) and Glial fibrillary acidic protein (GFAP) for predicting of post-TIPS HE', 'timeFrame': '12 months', 'description': 'Evaluation of the usefulness of sNfL and GFAP for predicting post-TIPS HE during follow-up. sNfL and GFAP will be determined from blood obtained prior to TIPS implantation using a single molecule array (SiMoA technology).'}, {'measure': 'Longitudinal assessment of sleep quality using the Pittsburgh Sleep Quality Index (PSQI)', 'timeFrame': '12 months', 'description': 'Sleep quality will be assessed in each participant using the validated PSQI. Sleep quality will be assessed at baseline and 1-, 3- and 6- months post-TIPS implantation.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Liver Cirrhosis', 'Hepatic Encephalopathy', 'Transjugular Intrahepatic Portosystemic Shunt', 'TIPS', 'Post-TIPS Hepatic Encephalopathy', 'Post-TIPS HE', 'Minimal Hepatic Encephalopathy'], 'conditions': ['Hepatic Encephalopathy', 'Liver Cirrhosis']}, 'referencesModule': {'references': [{'pmid': '40751304', 'type': 'DERIVED', 'citation': 'Kabelitz MA, Gairing SJ, Tiede A, Schleicher EM, Ahl LG, Wagner L, Zucker-Reimann F, Rieland H, Mauz JB, Weinmann-Menke J, Meyer BC, Pitton MB, Wedemeyer H, Galle PR, Sandmann L, Maasoumy B, Labenz C. Impact of Frailty on the Prognosis of Patients With Liver Cirrhosis Undergoing Insertion of a TIPS. Aliment Pharmacol Ther. 2026 Jan;63(1):109-118. doi: 10.1111/apt.70315. Epub 2025 Aug 1.'}]}, 'descriptionModule': {'briefSummary': 'Prediction of hepatic encephalopathy after insertion of a transjugular intrahepatic portosystemic stent shunt (post-TIPS HE) are critical for patient selection prior to TIPS insertion, and a currently unmet, clinically highly relevant need. In this prospective multicenter observational cohort study, the investigators aim to evaluate the ability of Stroop EncephalApp and the simplified Animal Naming Test (S-ANT1) in comparison to the goldstandard PHES to predict the occurence of post-TIPS HE in patients with decompensated liver cirrhosis. Moreover, secondary aims of this study include the detection of potential blood based biomarkers for prediction of post-TIPS HE and the predictive value of frailty and quality of life/sleep prior to TIPS insertion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants are recruited from the outpatient clinic or from the regular wards of the hospitals.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Liver cirrhosis (clinical, sonographic, CT-morphological, laparoscopic or histological)\n* TIPS indication: refractory ascites or secondary prophylaxis after variceal bleeding\n* Age ≥ 18 years\n* Ability to give consent\n* Consent to the study after comprehensive information\n\nExclusion Criteria:\n\n* Contraindication against TIPS insertion\n* Lack of consent\n* History of liver transplantation\n* Preemptive TIPS\n* Emergency TIPS\n* Severe neurological comorbidities'}, 'identificationModule': {'nctId': 'NCT05466669', 'briefTitle': 'Prediction of Post-TIPS Hepatic Encephalopathy in Patients With Liver Cirrhosis', 'organization': {'class': 'OTHER', 'fullName': 'Johannes Gutenberg University Mainz'}, 'officialTitle': 'Prediction of Post-TIPS Hepatic Encephalopathy in Patients With Liver Cirrhosis', 'orgStudyIdInfo': {'id': '20221'}}, 'contactsLocationsModule': {'locations': [{'zip': '55131', 'city': 'Mainz', 'state': 'Rhineland-Palatinate', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Christian Labenz, MD', 'role': 'CONTACT', 'email': 'Christian.Labenz@unimedizin-mainz.de', 'phone': '+496131172830'}, {'name': 'Simon Johannes Gairing, MD', 'role': 'CONTACT', 'email': 'SimonJohannes.Gairing@unimedizin-mainz.de', 'phone': '+496131176077'}], 'facility': 'Department of Internal Medicine I, University Medical Center of the Johannes Gutenberg-University Mainz', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '23562', 'city': 'Lübeck', 'state': 'Schleswig-Holstein', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Jens Uwe Marquardt, Professor', 'role': 'CONTACT', 'email': 'Jens.Marquardt@uksh.de', 'phone': '+4945150044101'}], 'facility': 'Department of Medicine I, University Hospital Schleswig-Holstein', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}], 'centralContacts': [{'name': 'Christian Labenz, MD', 'role': 'CONTACT', 'email': 'Christian.Labenz@unimedizin-mainz.de', 'phone': '+496131172830'}, {'name': 'Simon Johannes Gairing, MD', 'role': 'CONTACT', 'email': 'SimonJohannes.Gairing@unimedizin-mainz.de', 'phone': '+496131176077'}], 'overallOfficials': [{'name': 'Christian Labenz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Internal Medicine I, University Medical Center of the Johannes Gutenberg-University Mainz'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johannes Gutenberg University Mainz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Priv.-Doz. Dr. med.', 'investigatorFullName': 'Christian Labenz', 'investigatorAffiliation': 'Johannes Gutenberg University Mainz'}}}}