Ignite Creation Date:
2025-12-24 @ 5:28 PM
Ignite Modification Date:
2026-01-01 @ 11:42 AM
Study NCT ID:
NCT05689268
Status:
COMPLETED
Last Update Posted:
2023-09-21
First Post:
2021-12-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EUS-PPG vs HVPG in Portal Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D006975', 'term': 'Hypertension, Portal'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-09-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-20', 'studyFirstSubmitDate': '2021-12-01', 'studyFirstSubmitQcDate': '2023-01-17', 'lastUpdatePostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intra-class correlation coefficient between portal pressure gradient measurement by EUS and hepatic venous pressure gradient measurement measured by interventional radiology.', 'timeFrame': '1 day', 'description': 'Portal pressure gradient measurement will be performed by direct echoendoscopy-guided puncture with a 22 G needle of the portal vein and the suprahepatic vein. On the same day or on successive days, hepatic venous pressure gradient determination will be performed by interventional radiology. For this purpose, the free hepatic venous pressure and the wedged pressure will be measured using a balloon catheter and jugular approach, following the usual procedure.'}], 'secondaryOutcomes': [{'measure': 'Technical success of both procedures measured as the number of procedures successfully performed divided by the total number of patients.', 'timeFrame': '1 day', 'description': 'The percentage of echoendoscopy-guided portal pressure gradient (EUS-PPG) measurements versus the percentage of successful hepatic venous pressure gradient (HVPG) measurements using Chi-square will be compared.'}, {'measure': 'Adverse effects at 30 days after each procedure by clinical follow-up of patients at 24 hours, 7 days, and 30 days using the American Society of Gastrointestinal Endoscopy Severity grading system, from mild to fatal.', 'timeFrame': '30 days', 'description': 'Proportion of adverse events in the EUS-PPG and HVPG using Chi-square.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['EUS', 'Endoscopic ultrasound', 'Portal Hypertension', 'Portal pressure gradient', 'Hepatic venous pressure gradient'], 'conditions': ['Cirrhosis', 'Portal Hypertension']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the correlation of the calculated portal pressure gradient (PPG) obtained by direct portal and hepatic pressure measurements with a conventional 22 G needle guided by EUS and indirect portal vein pressure measurements using the interventional radiology based hepatic venous pressure gradient (HVPG) procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age above 18 years\n* Undergoing evaluation for chronic liver disease or portal hypertension\n* Signed informed consent\n\nExclusion Criteria:\n\n* Uncorrectable coagulopathy (INR above 1.5)\n* Uncorrectable thrombocytopenia (Platelets under 50,000)\n* Anticoagulation or antiplatelet therapy that cannot be discontinued\n* Biliary obstruction\n* Grade II ascites or more\n* Intrahepatic portal vein thrombosis\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT05689268', 'acronym': 'GRAPE', 'briefTitle': 'EUS-PPG vs HVPG in Portal Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'Hospital General Universitario de Alicante'}, 'officialTitle': 'EUS-portal Pressure Gradient (EUS-PPG). Prospective Study Compared With Hepatic Venous Pressure Gradient (HVPG)', 'orgStudyIdInfo': {'id': 'PI2021-135'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'EUS-PPG and HVPG', 'description': 'EUS-PPG and HVPG will be measured in all patients. Under deep sedation with propofol, an echoendoscopy will be performed. After identifying the left or middle suprahepatic vein, it will be punctured with a standard 22 G needle. The needle will be previously purged with heparinized saline and connected to a venous pressure monitor via an arterial pressure system, which will be calibrated to zero at the level of the axillary midline, at the level of the atrium. Subsequently, the left portal vein will be identified from the stomach or duodenum, repeating the procedure. From each vessel 3 measurements will be taken by flushing 1-2 ml of heparinized saline. The mean of the three measurements will be obtained.\n\nOn the same day or on successive days HVPG measurement will be performed.', 'interventionNames': ['Diagnostic Test: EUS-PPG and HVPG']}], 'interventions': [{'name': 'EUS-PPG and HVPG', 'type': 'DIAGNOSTIC_TEST', 'description': 'EUS-PPG and HVPG will be measured in all patients. Under deep sedation with propofol, an echoendoscopy will be performed. After identifying the left or middle suprahepatic vein, it will be punctured with a standard 22 G needle. The needle will be previously purged with heparinized saline and connected to a venous pressure monitor via an arterial pressure system, which will be calibrated to zero at the level of the axillary midline, at the level of the atrium. Subsequently, the left portal vein will be identified from the stomach or duodenum, repeating the procedure. From each vessel 3 measurements will be taken by flushing 1-2 ml of heparinized saline. The mean of the three measurements will be obtained.\n\nOn the same day or on successive days HVPG measurement will be performed.', 'armGroupLabels': ['EUS-PPG and HVPG']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03010', 'city': 'Alicante', 'country': 'Spain', 'facility': 'Unidad de Endoscopia. Hospital General Universitario de Alicante', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital General Universitario de Alicante', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Endoscopy Unit', 'investigatorFullName': 'Jose Ramon Aparicio Tormo', 'investigatorAffiliation': 'Hospital General Universitario de Alicante'}}}}