Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2026-02-23 @ 8:06 PM
Study NCT ID:
NCT04121520
Status:
COMPLETED
Last Update Posted:
2023-04-25
First Post:
2019-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perioperative Care of HVPG Measurement (CHESS1904): An International Multicenter Survey
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006975', 'term': 'Hypertension, Portal'}, {'id': 'D008103', 'term': 'Liver Cirrhosis'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-23', 'studyFirstSubmitDate': '2019-10-06', 'studyFirstSubmitQcDate': '2019-10-08', 'lastUpdatePostDateStruct': {'date': '2023-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-operative satisfaction', 'timeFrame': '1 day', 'description': "After the procedure of HVPG (within the same day), participants will be asked to complete a pain scale which was experienced during and after the HVPG procedure. The pain scale ranges from 0 to 10 with 0 representing 'not at all' and 10 representing 'excessively'."}], 'secondaryOutcomes': [{'measure': 'Pre-operative perception', 'timeFrame': '1 day', 'description': "At time of consent and within the same day of HVPG procedure, participants will be asked to complete a pain scale which was felt to be experienced during the HVPG procedure. The pain scale ranges from 0 to 10 with 0 representing 'not at all' and 10 representing 'excessively'."}, {'measure': 'Number of intra-operative complications', 'timeFrame': '1 day', 'description': 'Number of complications (e.g. vasovagal reflex, arrhymia, inadvertent arterial puncture, hypersensitivity to contrast agents, pneumothorax) happened during the HVPG procedure.'}, {'measure': 'Number of post-operative complications', 'timeFrame': '1 day', 'description': 'Number of complications (e.g. bleeding at the puncture point, contrast-induced nephropathy, infection, jugular vein thrombosis) happened after the HVPG procedure.'}, {'measure': 'Methods selection of HVPG measurement', 'timeFrame': '1 day', 'description': 'Including the selection of routes for insertion of catheter, hepatic vein used for the assessment and the angiographic catheter used during the HVPG procedure.'}, {'measure': 'The result of HVPG measurement', 'timeFrame': '1 day', 'description': 'The mean value of HVPG measurements.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Portal Hypertension', 'Cirrhosis, Liver']}, 'referencesModule': {'references': [{'pmid': '26047908', 'type': 'BACKGROUND', 'citation': 'de Franchis R; Baveno VI Faculty. Expanding consensus in portal hypertension: Report of the Baveno VI Consensus Workshop: Stratifying risk and individualizing care for portal hypertension. J Hepatol. 2015 Sep;63(3):743-52. doi: 10.1016/j.jhep.2015.05.022. Epub 2015 Jun 3. No abstract available.'}, {'pmid': '27786365', 'type': 'BACKGROUND', 'citation': 'Garcia-Tsao G, Abraldes JG, Berzigotti A, Bosch J. Portal hypertensive bleeding in cirrhosis: Risk stratification, diagnosis, and management: 2016 practice guidance by the American Association for the study of liver diseases. Hepatology. 2017 Jan;65(1):310-335. doi: 10.1002/hep.28906. Epub 2016 Dec 1. No abstract available.'}, {'pmid': '19724251', 'type': 'BACKGROUND', 'citation': 'Bosch J, Abraldes JG, Berzigotti A, Garcia-Pagan JC. The clinical use of HVPG measurements in chronic liver disease. Nat Rev Gastroenterol Hepatol. 2009 Oct;6(10):573-82. doi: 10.1038/nrgastro.2009.149. Epub 2009 Sep 1.'}, {'pmid': '30215362', 'type': 'BACKGROUND', 'citation': 'Qi X, Berzigotti A, Cardenas A, Sarin SK. Emerging non-invasive approaches for diagnosis and monitoring of portal hypertension. Lancet Gastroenterol Hepatol. 2018 Oct;3(10):708-719. doi: 10.1016/S2468-1253(18)30232-2.'}]}, 'descriptionModule': {'briefSummary': 'Hepatic venous pressure gradient (HVPG) is an invasive test and requires technical skills of the operator and specialized instruments. HVPG measurement and anesthesia can cause stress responses in the body, which in turn lead to inflammatory response and immune function suppression. Thus, the perioperative care for patients undergoing HVPG measurement is crucial. This research trial studies comprehensive patient and medical worker questionnaires in predicting complications in patients with cirrhosis undergoing HVPG measurement. Comprehensive patient and medical worker questionnaires may help identify complications, such as the need for assistance in taking medication, decreased mobility and released tension that may improve outcomes.', 'detailedDescription': 'Portal hypertension is an important factor affecting the clinical outcomes of cirrhosis patients, and its severity determines the occurrence of development of cirrhosis complications, such as rupture and bleeding of gastroesophageal varices, ascites, and hepatorenal syndrome. The direct measurement of portal pressure is an extremely invasive and high-risk procedure. In addition, changes in intra-abdominal pressure will affect the portal pressure, which leads to unreliable results. The hepatic venous pressure gradient (HVPG) is the difference between wedged hepatic venous pressure and free hepatic venous pressure and reflects the pressure difference between the hepatic portal vein and the intra-abdominal veins. In recent years, the status of HVPG in clinical application of cirrhotic portal hypertension has gradually improved. In 2016, the American Association for the Study of Liver Diseases (AASLD) issued a consensus on risk stratification, diagnosis, and management of portal hypertensive bleeding in cirrhosis and re-emphasized the value of HVPG in assessing the cirrhosis staging, occurrence of complications and treatment goals. However, HVPG is an invasive test and requires technical skills of the operator and specialized instruments. HVPG measurement and anesthesia can cause stress responses in the body, which in turn lead to inflammatory response and immune function suppression. Thus, the perioperative care for patients undergoing HVPG measurement is crucial. This research trial studies comprehensive patient and medical worker questionnaires in predicting complications in patients with cirrhosis undergoing HVPG measurement. Comprehensive patient and medical worker questionnaires may help identify complications, such as the need for assistance in taking medication, decreased mobility and released tension that may improve outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with cirrhosis who were scheduled to undergo HVPG measurement', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nEligible participants must meet the following criteria:\n\n1. aged between 18-75 years, no restriction on gender;\n2. clinically and/or pathologically diagnosed sinusoidal cirrhosis;\n3. with written informed consent\n4. scheduled to undergo HVPG measurement according to the following indications: 1) assessment of the efficacy of primary and secondary prophylactic drugs for gastroesophageal variceal bleeding; 2) predicting the risk of gastroesophageal variceal bleeding and guiding the selection of the treatment regimens; 3) predicting of risk, progression, and clinical outcomes of decompensation events in cirrhosis; 4) evaluation of the efficacy of new drugs; 5) evaluation of the accuracy of new non-invasive techniques; diagnosis and differential diagnosis of types of portal hypertension.\n\nExclusion Criteria:\n\nThose cases that meet any of the following criteria should be excluded:\n\n1. contradictions for HVPG measurement;\n2. pregnant or lactating woman;\n3. severe coagulopathy (international normalized ratio\\>5);\n4. severe heart, lung, or kidney disease.'}, 'identificationModule': {'nctId': 'NCT04121520', 'briefTitle': 'Perioperative Care of HVPG Measurement (CHESS1904): An International Multicenter Survey', 'organization': {'class': 'OTHER', 'fullName': 'Hepatopancreatobiliary Surgery Institute of Gansu Province'}, 'officialTitle': 'Perioperative Care of Hepatic Venous Pressure Gradient (HVPG) Measurement (CHESS1904): An International Multicenter Survey', 'orgStudyIdInfo': {'id': 'CHESS1904'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observational', 'description': 'At time of consent and within the same day of HVPG measurement, participants will be asked to complete a pre-operative assessment. Relevant statistics will be recorded during the HVPG procedure. Post-operative complication will also be collected and the satisfaction survey will be conducted.', 'interventionNames': ['Other: Questionnaire']}], 'interventions': [{'name': 'Questionnaire', 'type': 'OTHER', 'description': '1. Comprehensive perioperative assessment\n2. Questionnaire administration', 'armGroupLabels': ['Observational']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Recife', 'country': 'Brazil', 'facility': 'Universidade Federal de Pernambuco', 'geoPoint': {'lat': -8.05389, 'lon': -34.88111}}, {'city': 'Lanzhou', 'state': 'Gansu', 'country': 'China', 'facility': 'The First Hospital of Lanzhou University', 'geoPoint': {'lat': 36.05701, 'lon': 103.83987}}, {'city': 'Xingtai', 'state': 'Hebei', 'country': 'China', 'facility': "Xingtai People's Hospital", 'geoPoint': {'lat': 37.06217, 'lon': 114.49272}}, {'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'facility': 'Shandong Provincial Hospital affiliated to Shandong University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'The First Affiliated Hospital, School of Medicine, Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Jakarta', 'country': 'Indonesia', 'facility': 'Universitas Indonesia, Cipto Mangunkusumo National General Hospital', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}, {'city': 'Bologna', 'country': 'Italy', 'facility': 'S. Orsola-Malpighi Hospital, University of Bologna', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'city': 'Chiba', 'country': 'Japan', 'facility': 'Chiba University Graduate School of Medicine', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Hanyang University College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Ankara University School of Medicine', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Xiaolong Qi, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'LanZhou University'}, {'name': 'Necati Örmeci, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ankara University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hepatopancreatobiliary Surgery Institute of Gansu Province', 'class': 'OTHER'}, 'collaborators': [{'name': 'LanZhou University', 'class': 'OTHER'}, {'name': 'Shandong Provincial Hospital', 'class': 'OTHER_GOV'}, {'name': "Xingtai People's Hospital", 'class': 'OTHER'}, {'name': 'Zhejiang University', 'class': 'OTHER'}, {'name': 'Ankara University', 'class': 'OTHER'}, {'name': 'Chiba University Graduate School of Medicine', 'class': 'UNKNOWN'}, {'name': 'Universitas Indonesia, Cipto Mangunkusumo National General Hospital', 'class': 'UNKNOWN'}, {'name': 'S. Orsola-Malpighi Hospital, University of Bologna', 'class': 'UNKNOWN'}, {'name': 'Universidade Federal de Pernambuco', 'class': 'OTHER'}, {'name': 'Hanyang University College of Medicine', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Institute of Portal Hypertension', 'investigatorFullName': 'Xiaolong Qi', 'investigatorAffiliation': 'Hepatopancreatobiliary Surgery Institute of Gansu Province'}}}}