Ignite Creation Date:
2025-12-24 @ 3:38 PM
Ignite Modification Date:
2025-12-26 @ 11:44 AM
Study NCT ID:
NCT05052892
Status:
UNKNOWN
Last Update Posted:
2023-04-25
First Post:
2021-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Novel Spleen-dedicated Stiffness Measured by FibroScan to Evaluate Cirrhotic Portal Hypertension (CHESS2105)
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-09-28', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2025-09-27', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-23', 'studyFirstSubmitDate': '2021-09-02', 'studyFirstSubmitQcDate': '2021-09-12', 'lastUpdatePostDateStruct': {'date': '2023-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy of a new model based on spleen stiffness (kPa) measured by transient elastography for diagnosing portal hypertension.', 'timeFrame': '1 years', 'description': 'In HVPG (mmHg) as reference method in evaluating portal pressure measured by intervention specialist , to develop a new model based on spleen stiffness (kPa) measured by transient elastography and evaluate the accuracy in diagnosing portal hypertension.'}], 'secondaryOutcomes': [{'measure': 'Accuracy of model based on spleen stiffness (kPa) measured by transient elastography for predicting incidence of liver decompensation in patients with compenstaed cirrhosis', 'timeFrame': '3 years', 'description': 'To develop a novel model based on spleen stiffness (kPa) measured by transient elastography for predicting the incidence of liver decompensation in patients with compenstaed cirrhosis.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cirrhosis', 'spleen stiffness', 'portal hypertension', 'hepatic venous pressure gradient'], 'conditions': ['Portal Hypertension']}, 'referencesModule': {'references': [{'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.'}, {'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': '14767976', 'type': 'BACKGROUND', 'citation': 'Groszmann RJ, Wongcharatrawee S. The hepatic venous pressure gradient: anything worth doing should be done right. Hepatology. 2004 Feb;39(2):280-2. doi: 10.1002/hep.20062. No abstract available.'}, {'pmid': '18397389', 'type': 'BACKGROUND', 'citation': 'Bureau C, Metivier S, Peron JM, Selves J, Robic MA, Gourraud PA, Rouquet O, Dupuis E, Alric L, Vinel JP. Transient elastography accurately predicts presence of significant portal hypertension in patients with chronic liver disease. Aliment Pharmacol Ther. 2008 Jun;27(12):1261-8. doi: 10.1111/j.1365-2036.2008.03701.x. Epub 2008 Apr 4.'}, {'pmid': '22643348', 'type': 'BACKGROUND', 'citation': 'Colecchia A, Montrone L, Scaioli E, Bacchi-Reggiani ML, Colli A, Casazza G, Schiumerini R, Turco L, Di Biase AR, Mazzella G, Marzi L, Arena U, Pinzani M, Festi D. Measurement of spleen stiffness to evaluate portal hypertension and the presence of esophageal varices in patients with HCV-related cirrhosis. Gastroenterology. 2012 Sep;143(3):646-654. doi: 10.1053/j.gastro.2012.05.035. Epub 2012 May 27.'}, {'pmid': '17464971', 'type': 'BACKGROUND', 'citation': 'Vizzutti F, Arena U, Romanelli RG, Rega L, Foschi M, Colagrande S, Petrarca A, Moscarella S, Belli G, Zignego AL, Marra F, Laffi G, Pinzani M. Liver stiffness measurement predicts severe portal hypertension in patients with HCV-related cirrhosis. Hepatology. 2007 May;45(5):1290-7. doi: 10.1002/hep.21665.'}, {'pmid': '29731186', 'type': 'BACKGROUND', 'citation': 'Bastard C, Miette V, Cales P, Stefanescu H, Festi D, Sandrin L. A Novel FibroScan Examination Dedicated to Spleen Stiffness Measurement. Ultrasound Med Biol. 2018 Aug;44(8):1616-1626. doi: 10.1016/j.ultrasmedbio.2018.03.028. Epub 2018 May 3.'}, {'pmid': '31444849', 'type': 'BACKGROUND', 'citation': 'Stefanescu H, Marasco G, Cales P, Fraquelli M, Rosselli M, Ganne-Carrie N, de Ledinghen V, Ravaioli F, Colecchia A, Rusu C, Andreone P, Mazzella G, Festi D. A novel spleen-dedicated stiffness measurement by FibroScan(R) improves the screening of high-risk oesophageal varices. Liver Int. 2020 Jan;40(1):175-185. doi: 10.1111/liv.14228. Epub 2019 Sep 11.'}]}, 'descriptionModule': {'briefSummary': 'Portal hypertension contributed to the main complications of liver cirrhosis. Currently, hepatic venous pressure gradient (HVPG) was the reference standard for evaluating portal pressure in patients with cirrhosis. However, the practice of HVPG is limited to require the extensive experience and highly specialized centers. In recent years, non-invasive methods were proposed to predict the degree of cirrhotic portal hypertension. Of them, liver stiffness measured by FibroScan had shown good performance for predicting clinically significant portal hypertension. However, the correlation between liver stiffness and HVPG was poor when HVPG was more than 12mmHg. Since the spleen was stiffer than the liver, the current vibration-controlled transient elastography examination is dedicated to the liver, rather than the spleen. Very recently, a novel spleen-dedicated stiffness measured by FibroScan was proposed. The prospective, multicenter study aims to evaluate the correlation between SS (measured by the novel FibroScan) and HVPG, and further develop a novel model based on SS for predicting the liver decompensation in patients with compenstaed cirrhosis.', 'detailedDescription': 'Portal hypertension contributed to the main complications of liver cirrhosis. Currently, hepatic venous pressure gradient (HVPG) was the reference standard for evaluating portal pressure in patients with cirrhosis. However, the practice of HVPG is limited to require the extensive experience and highly specialized centers. In recent years, non-invasive methods were proposed to predict the degree of cirrhotic portal hypertension. Of them, liver stiffness measured by FibroScan had shown good performance for predicting clinically significant portal hypertension. However, the correlation between liver stiffness and HVPG was poor when HVPG was more than 12mmHg. Since the spleen was stiffer than the liver, the current vibration-controlled transient elastography examination is dedicated to the liver, rather than the spleen. Very recently, a novel spleen-dedicated stiffness measured by FibroScan was proposed. The prospective, multicenter study (CHESS2105 leaded by The First Hospital of Lanzhou University and Shulan (Hangzhou) Hospital) aims to evaluate the correlation between SS (measured by the novel FibroScan) and HVPG, and further develop a novel model based on SS for predicting the liver decompensation in patients with compenstaed cirrhosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients was fulfilled the diagnosis of cirrhosis based on radiological, histological features of liver cirrhosis.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. age above or equal to 18-year-old\n2. fulfilled diagnosis of cirrhosis based on radiological, histological features of liver cirrhosis\n3. signed informed consent\n\nExclusion criteria:\n\n1. Non-cirrhotic portal hypertension\n2. Lactation or pregnancy\n3. Suspicious or confirmed hepatocellular carcinoma\n4. Asplenia or splenectomy\n5. Incomplete clinical information'}, 'identificationModule': {'nctId': 'NCT05052892', 'briefTitle': 'A Novel Spleen-dedicated Stiffness Measured by FibroScan to Evaluate Cirrhotic Portal Hypertension (CHESS2105)', 'organization': {'class': 'OTHER', 'fullName': 'Hepatopancreatobiliary Surgery Institute of Gansu Province'}, 'officialTitle': 'A Novel Spleen-dedicated Stiffness Measured by FibroScan to Evaluate Cirrhotic Portal Hypertension (CHESS2105): A Prospective, Multicenter Study', 'orgStudyIdInfo': {'id': 'CHESS2105'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Training cohort', 'description': 'Patients were fulfilled diagnosis of cirrhosis based on radiological, histological features of liver cirrhosis.', 'interventionNames': ['Diagnostic Test: Hepatic venous pressure gradient']}, {'label': 'Validation cohort', 'description': 'Patients were fulfilled diagnosis of cirrhosis based on radiological, histological features of liver cirrhosis.', 'interventionNames': ['Diagnostic Test: Hepatic venous pressure gradient']}], 'interventions': [{'name': 'Hepatic venous pressure gradient', 'type': 'DIAGNOSTIC_TEST', 'description': 'All patients underwent measurement of HVPG under local anesthesia.', 'armGroupLabels': ['Training cohort', 'Validation cohort']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hangzhou', 'country': 'China', 'contacts': [{'name': 'Huadong Yan', 'role': 'CONTACT'}, {'name': 'Huadong Yan, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Shulan (Hangzhou) Hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Lanzhou', 'country': 'China', 'contacts': [{'name': 'Liting Zhang', 'role': 'CONTACT'}, {'name': 'Liting Zhang, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The First Hospital of Lanzhou University', 'geoPoint': {'lat': 36.05701, 'lon': 103.83987}}, {'city': 'Taiyuan', 'country': 'China', 'contacts': [{'name': 'Ying Guo', 'role': 'CONTACT'}, {'name': 'Ying Guo, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "The Third People's Hospital of Taiyuan", 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}], 'centralContacts': [{'name': 'Xiaolong Qi, MD', 'role': 'CONTACT', 'email': 'qixiaolong@vip.163.com', 'phone': '+8618588602600'}, {'name': 'Ruiling He, MD', 'role': 'CONTACT', 'email': '1037039754@qq.com', 'phone': '+8618153674392'}], 'overallOfficials': [{'name': 'Lanjuan Li, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Shulan (Hangzhou) Hospital'}, {'name': 'Xiaolong Qi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'LanZhou University'}, {'name': 'Huadong Yan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shulan (Hangzhou) Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hepatopancreatobiliary Surgery Institute of Gansu Province', 'class': 'OTHER'}, 'collaborators': [{'name': 'LanZhou University', 'class': 'OTHER'}, {'name': 'Shulan (Hangzhou) Hospital', 'class': 'OTHER'}, {'name': "The Third People's Hospital of Taiyuan", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Xiaolong Qi', 'investigatorAffiliation': 'Hepatopancreatobiliary Surgery Institute of Gansu Province'}}}}