Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2025-12-25 @ 7:08 PM
Study NCT ID:
NCT03584204
Status:
RECRUITING
Last Update Posted:
2021-10-05
First Post:
2018-05-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Skeletal Muscle Parameters of Liver Cirrhosis in Non-invasive Imaging and Outcome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D055948', 'term': 'Sarcopenia'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D065290', 'term': 'Acute-On-Chronic Liver Failure'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D017114', 'term': 'Liver Failure, Acute'}, {'id': 'D017093', 'term': 'Liver Failure'}, {'id': 'D048550', 'term': 'Hepatic Insufficiency'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-04', 'studyFirstSubmitDate': '2018-05-08', 'studyFirstSubmitQcDate': '2018-07-10', 'lastUpdatePostDateStruct': {'date': '2021-10-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival time', 'timeFrame': 'up to 60 months', 'description': 'time of survival'}], 'secondaryOutcomes': [{'measure': 'Time to clinical acute decompensations', 'timeFrame': 'up to 60 months', 'description': 'time to occurrence of acute decompensations of liver cirrhosis (readmissions, hepatic encephalopathy, bleeding, ascites, hepatorenal syndrome, infections)'}, {'measure': 'Time to clinical acute-on-chronic liver failure', 'timeFrame': 'up to 60 months', 'description': 'acute-on-chronic liver failure according to EASL-CLIF-C definition (grade 1 (best) to 3 (worst)'}, {'measure': 'Development of sarcopenia', 'timeFrame': 'up to 60 months', 'description': 'Assessment of sarcopenia according to EASL-guideline'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sarcopenia', 'cirrhosis', 'transjugular intrahepatic portosystemic shunt', 'TIPS', 'acute-on-chronic liver failure', 'ACLF'], 'conditions': ['Liver Cirrhosis']}, 'referencesModule': {'references': [{'pmid': '37586906', 'type': 'DERIVED', 'citation': 'Praktiknjo M, Zhou T, Krusken M, Jacob T, Sprinkart AM, Nowak S, Kimmann M, Dold L, Chang J, Jansen C, Strassburg CP, Luetkens J, Weismuller TJ. Myosteatosis independently predicts transplant-free survival in patients with primary sclerosing cholangitis. Dig Liver Dis. 2023 Nov;55(11):1543-1547. doi: 10.1016/j.dld.2023.08.037. Epub 2023 Aug 14.'}, {'pmid': '35492329', 'type': 'DERIVED', 'citation': 'Faron A, Abu-Omar J, Chang J, Bohling N, Sprinkart AM, Attenberger U, Rockstroh JK, Luu AM, Jansen C, Strassburg CP, Trebicka J, Luetkens J, Praktiknjo M. Combination of Fat-Free Muscle Index and Total Spontaneous Portosystemic Shunt Area Identifies High-Risk Cirrhosis Patients. Front Med (Lausanne). 2022 Apr 12;9:831005. doi: 10.3389/fmed.2022.831005. eCollection 2022.'}, {'pmid': '31644538', 'type': 'DERIVED', 'citation': 'Queck A, Thomas D, Jansen C, Schreiber Y, Ruschenbaum S, Praktiknjo M, Schwarzkopf KM, Mucke MM, Schierwagen R, Uschner FE, Meyer C, Claria J, Zeuzem S, Geisslinger G, Trebicka J, Lange CM. Pathophysiological role of prostanoids in coagulation of the portal venous system in liver cirrhosis. PLoS One. 2019 Oct 23;14(10):e0222840. doi: 10.1371/journal.pone.0222840. eCollection 2019.'}, {'pmid': '30939488', 'type': 'DERIVED', 'citation': 'Praktiknjo M, Clees C, Pigliacelli A, Fischer S, Jansen C, Lehmann J, Pohlmann A, Lattanzi B, Krabbe VK, Strassburg CP, Arroyo V, Merli M, Meyer C, Trebicka J. Sarcopenia Is Associated With Development of Acute-on-Chronic Liver Failure in Decompensated Liver Cirrhosis Receiving Transjugular Intrahepatic Portosystemic Shunt. Clin Transl Gastroenterol. 2019 Apr;10(4):e00025. doi: 10.14309/ctg.0000000000000025.'}]}, 'descriptionModule': {'briefSummary': 'The principal aim of this study is to analyse L3-SMI (skeletal muscle index) in a cohort of patients with decompensated liver cirrhosis and TIPS (transjugular intrahepatic portosystemic shunt), and compare the prognostic power with TPMT (transverse psoas muscle thickness). Furthermore, the role of myosteatosis, determined in CT by L3-SMI, MRI and ultrasound will be studied.', 'detailedDescription': 'The principal aim of this study is to analyse L3-SMI (skeletal muscle index) in a cohort of patients with decompensated liver cirrhosis and TIPS (transjugular intrahepatic portosystemic shunt), and compare the prognostic power with TPMT (transverse psoas muscle thickness). Furthermore, the role of myosteatosis, determined in CT by L3-SMI, MRI and ultrasound will be studied.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with liver cirrhosis of any etiology and CT scan available', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* liver cirrhosis of any etiology\n* CT scan available\n\nExclusion Criteria:\n\n* HCC or any malignant disease'}, 'identificationModule': {'nctId': 'NCT03584204', 'acronym': 'SLIM', 'briefTitle': 'Skeletal Muscle Parameters of Liver Cirrhosis in Non-invasive Imaging and Outcome', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Bonn'}, 'officialTitle': 'Role of Skeletal Muscle Parameters in Imaging Analysis in the Prediction of Outcome in Patients With Liver Cirrhosis', 'orgStudyIdInfo': {'id': 'SLIM'}}, 'armsInterventionsModule': {'interventions': [{'name': 'imaging', 'type': 'DIAGNOSTIC_TEST', 'description': 'computed tomography, magnetic resosnance imaging, ultrasound'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bonn', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Michael Praktiknjo, MD', 'role': 'CONTACT', 'email': 'michael.praktiknjo@ukbonn.de', 'phone': '+49228 28715770'}], 'facility': 'University Hospital Bonn', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'city': 'Frankfurt', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Jonel Trebicka, MD, PHD', 'role': 'CONTACT', 'email': 'jonel.trebicka@kgu.de'}], 'facility': 'University of Frankfurt', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'city': 'Roma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Manuela Merli, Prof.', 'role': 'CONTACT'}], 'facility': 'Sapienza University of Rome', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}], 'centralContacts': [{'name': 'Michael Praktiknjo, MD', 'role': 'CONTACT', 'email': 'michael.praktiknjo@ukbonn.de', 'phone': '+49228 287 15770'}, {'name': 'Johannes Chang, MD', 'role': 'CONTACT', 'email': 'johannes.chang@ukbonn.de', 'phone': '+49228 287 15770'}], 'overallOfficials': [{'name': 'Michael Praktiknjo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Bonn'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Bonn', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Roma La Sapienza', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Michael Praktiknjo', 'investigatorAffiliation': 'University Hospital, Bonn'}}}}