Ignite Creation Date:
2025-12-24 @ 2:21 PM
Ignite Modification Date:
2026-02-22 @ 7:35 PM
Study NCT ID:
NCT06513195
Status:
RECRUITING
Last Update Posted:
2024-07-26
First Post:
2024-07-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EUS-guided Response Assessment to NSBB
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006975', 'term': 'Hypertension, Portal'}, {'id': 'D005355', 'term': 'Fibrosis'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-25', 'studyFirstSubmitDate': '2024-07-08', 'studyFirstSubmitQcDate': '2024-07-16', 'lastUpdatePostDateStruct': {'date': '2024-07-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'EUS-guided response assessment to NSBB in the treatment of CSPH.', 'timeFrame': 'Three months', 'description': 'To assess if a positive response to non-selective beta-blockers (NSBB) treatment, as determined by a reduction of 10% or more in the hepatic venous pressure gradient (HVPG) and/or a decrease to values less than 12 mmHg, can be similarly observed using endoscopic ultrasound-guided portal pressure gradient (EUS-PPG) measurement.'}], 'secondaryOutcomes': [{'measure': 'Correlation of EUS-PPG with HVPG', 'timeFrame': 'Three months', 'description': 'To assess the correlation of EUS-PPG and HVPG before treatment start as well as after treatment start with NSBB'}, {'measure': 'Correlation of FHVP with HVP.', 'timeFrame': 'Three months', 'description': 'To assess the correlation of EUS-guided hepatic venous pressure (HVP) and transjugular free hepatic venous pressure (FHVP) measurement before treatment start as well as after treatment start with NSBB.'}, {'measure': 'Correlation of PVP with WHVP.', 'timeFrame': 'Three months', 'description': 'To assess the correlation of EUS-guided portal venous pressure (PVP) and transjugular wedged hepatic venous pressure (WHVP) measurement before treatment start as well as after treatment start with NSBB.'}, {'measure': 'CSPH assessed via EUS-guided pressure measurement.', 'timeFrame': 'Three months', 'description': 'To determine if the current definition of CSPH (i.e. HVPG \\>/= 10 mmHg) can be adopted for portal tension measurement via EUS-PPG.'}, {'measure': 'Correlation of sequential EUS-PPG and HVPG with non-invasive assessment tools before/after treatment with NSBB.', 'timeFrame': 'Three months', 'description': 'To evaluate the correlation of sequential PPG and HVPG measurements, before and after treatment start with NSBB, with (the evolution of) non-invasive assessment tools. Non-invasive tools evaluated are fibrosis-4 (FIB-4) score, AST to platelet ratio index (APRI), liver stiffness-spleen size-to-platelet ratio-score (LSPS), platelet count to spleen diameter ratio (PSR), liver stiffness measurement (LSM) and spleen stiffness measurement (SSM).'}, {'measure': 'Safety of repeated EUS-PPG', 'timeFrame': '14 weeks', 'description': 'To assess the number of participants with any adverse event related to the (repeated) EUS-guided portal pressure gradient measurements. Potential risks associated with the study-specific intervention include fever, (minor) haemorrhage, (minor) infection, inflammation, pain/discomfort, (minor) vessel trauma, vessel occlusion/thrombosis, allergic reaction to medication\\*, aspiration\\*, cardiac arrhythmia or arrest\\*, respiratory depression or arrest\\*, death\\*. Adverse events indicated with \\* are related to the gastrointestinal endoscopic procedure required for the EUS-PPG intervention and are not specific to the device.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['portal hypertension', 'EUS-PPG', 'HVPG', 'cirrhosis', 'non-selective beta blockers'], 'conditions': ['Portal Hypertension Related to Cirrhosis']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if endoscopic ultrasound (EUS)-guided portal pressure measurement can determine the treatment response to non-selective beta-blockers (NSBB) in patients with cirrhosis and clinically significant portal hypertension (CSPH). Participants will undergo EUS-guided portal pressure measurement before start of Carvedilol en after three months of treatment. EUS-guided measurements will be paired with transjugular hepatic venous pressure gradient (HVPG) measurement as well as non-invasive tests for assessment of portal hypertension.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a clinical and/or pathological diagnosis of compensated cirrhosis.\n* Patients with suspicion of CSPH and thus indication for NSBB treatment.\n* Patients not yet on NSBB therapy.\n* Patients willing and able to undergo repeated HVPG and EUS-guided pressure measurements as per protocol.\n\nExclusion Criteria:\n\nGeneral criteria\n\n* Patient is \\<18 or \\>80 years of age\n* Patient is pregnant, breast-feeding or planning to become pregnant during the course of the study\n* Patient is unwilling or unable to sign the informed consent\n* Patients in whom general anesthesia or endoscopic procedures are contraindicated Medical criteria\n* Patients with cirrhosis and HCC Portopulmonary hypertension Portal or splanchnic venous thrombosis Prior TIPS Prior liver transplantation\n* Non-cirrhotic portal hypertension or pre-sinusoidal liver disease\n* Cholestatic liver disease with total bilirubin \\>3 mg/dl\n* Previous total or partial splenectomy\n* Known infection that is not controlled by medical intervention\n* Patients with contraindications for non-selective beta-blocker therapy, including but not limited to the following baseline vital signs:\n\nSystolic BP \\<100 mmHg HR \\<50 bpm\n\n* Patients with reduced life expectancy described by an ASA score of 4 or 5\n* INR \\>1.7 or platelet count \\<50.000 per mm3\n* eGFR \\<50 ml/min/1.73m2 (CKD-EPI formula) Anatomical criteria\n* Anatomical abnormalities that prevent access via EUS-guided puncture to the hepatic vein or intrahepatic portion of the portal vein, including anatomy that predisposes to difficult to reach puncture sites or an inadequate needle angle.\n* Visualization of ascites interposing the puncture tract on EUS\n* Diagnosis of portal vein thrombosis during EUS\n* Evidence of active gastrointestinal bleeding during EUS'}, 'identificationModule': {'nctId': 'NCT06513195', 'briefTitle': 'EUS-guided Response Assessment to NSBB', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': 'Endoscopic Ultrasound Guided Response Assessment to Non-selective Beta-blockers in the Treatment of Clinically Significant Portal Hypertension', 'orgStudyIdInfo': {'id': 's67433'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EUS-PPG before and after NSBB', 'description': 'Patients will undergo EUS-PPG and HVPG before and after NSBB treatment and will thus serve as their own control.', 'interventionNames': ['Procedure: endoscopic ultrasound-guided portal pressure measurement']}], 'interventions': [{'name': 'endoscopic ultrasound-guided portal pressure measurement', 'type': 'PROCEDURE', 'otherNames': ['EUS-PPG'], 'description': 'The portal pressure gradient will be determined by endoscopic ultrasound-guided pressure measurement in the hepatic vein and the portal vein. The gradient will be calculated by substracting the hepatic vein pressure from the portal vein pressure.', 'armGroupLabels': ['EUS-PPG before and after NSBB']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'state': 'Vlaams-Brabant', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Emma Vanderschueren, MD', 'role': 'CONTACT', 'email': 'emma.vanderschueren@uzleuven.be', 'phone': '000-000-0000', 'phoneExt': '003216349518'}], 'facility': 'University Hospital Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'centralContacts': [{'name': 'Emma Vanderschueren, MD', 'role': 'CONTACT', 'email': 'emma.vanderschueren@uzleuven.be', 'phone': '0032 16 345918'}, {'name': 'Petra Windmolders', 'role': 'CONTACT', 'email': 'petra.windmolders@uzleuven.be', 'phone': '003216 347581'}], 'overallOfficials': [{'name': 'Schalk van der Merwe, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitaire Ziekenhuizen KU Leuven'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Patient confidentiality'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}