Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-02-23 @ 4:55 AM
Study NCT ID:
NCT05204251
Status:
UNKNOWN
Last Update Posted:
2023-10-10
First Post:
2022-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Quality of Life in Patients Referred for Transjugular Intrahepatic Portosystemic Shunt
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-06', 'studyFirstSubmitDate': '2022-01-10', 'studyFirstSubmitQcDate': '2022-01-10', 'lastUpdatePostDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mental component of quality of Life of the', 'timeFrame': '45 minutes', 'description': 'Assessment of the mental component of quality of life by a generic questionnaire (SF-36),'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic liver disease', 'TIPS', 'Quality of life'], 'conditions': ['Chronic Liver Disease']}, 'descriptionModule': {'briefSummary': "Patient with Advanced Chronic Liver Disease often present portal hypertension which may lead to bleading or ascites.\n\nOne of the treatment of portal hypertension in these patients is the placement of a Transjugular Intrahepatic Portosystemic Shunt (TIPS).\n\nThe indications for placing TIPS take on various clinical presentations, the most classic being digestive haemorrhage by rupture of oesophageal and/or gastric varices and refractory ascites.\n\nTIPS placement involves changes in haemodynamics and liver function that may alter the patients' condition and quality of life.\n\nVery few articles have evaluated the quality of life of these patients and when quality of life is evaluated it is mostly with not adapted or not validated scales.\n\nThe main objective of this study is to evaluate the quality of life of patients who have undergone TIPS using a validated and standardised quality of life questionnaire (the SF-36 questionnaire)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient with Advanced Chronic Liver Disease who underwent a Transjugular Intrahepatic Portosystemic Shunt (TIPS) placement at the University Hospital of Strasbourg', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Patients referred to the TIPS service between January 2012 and October 2020 at the University Hospitals of Strasbourg, with a follow-up period of at least 1 month\n* Subjects who have not expressed any opposition to the use of their medical data for research purposes\n* For subjects invited to fill in the questionnaires: subject having expressed his/her agreement with the use of his/her medical data in the framework of the current study\n\nExclusion Criteria:\n\n* Diseased patient\n* Liver transplant patient following TIPS\n* Pregnancy\n* Patient in a vulnerable situation\n* Patient under court protection, guardianship or trusteeship\n* Difficulties in understanding the questionnaire\n* Impossible to give the subject informed information (subject in an emergency situation, difficulties in understanding the subject, etc.)\n* Subject under legal protection'}, 'identificationModule': {'nctId': 'NCT05204251', 'acronym': 'TIPS', 'briefTitle': 'Evaluation of the Quality of Life in Patients Referred for Transjugular Intrahepatic Portosystemic Shunt', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Evaluation of the Quality of Life in Patients Referred for Transjugular Intrahepatic Portosystemic Shunt (TIPS) - Pilot Observational Cross-sectional Study', 'orgStudyIdInfo': {'id': '8338'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Questionnaire', 'type': 'BEHAVIORAL', 'description': 'Quality of Life assessed with the SF-36 questionnaire'}]}, 'contactsLocationsModule': {'locations': [{'zip': '6720', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Pierre DE MARINI', 'role': 'CONTACT', 'email': 'pierre.demarini@chru-strasbourg.fr', 'phone': '+33 3.88.12.71.43'}, {'name': 'Pierre DE MARINI', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Michel GREGET', 'role': 'SUB_INVESTIGATOR'}, {'name': 'François FAITOT', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Afshin GANGI', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Emanuele BOATTA', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Roberto Luigi CAZZATO', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Iulian ENESCU', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Camille BESCH', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Baptiste MICHARD', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Service d'Imagerie Interventionnelle Vasculaire - CHU de Strasbourg - France", 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}