Ignite Creation Date:
2025-12-24 @ 7:47 PM
Ignite Modification Date:
2025-12-25 @ 5:24 PM
Study NCT ID:
NCT06392503
Status:
RECRUITING
Last Update Posted:
2024-04-30
First Post:
2024-04-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Noninvasive Diagnosis Model for High-risk Varices in Cirrhosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014648', 'term': 'Varicose Veins'}, {'id': 'D008103', 'term': 'Liver Cirrhosis'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-26', 'studyFirstSubmitDate': '2024-04-26', 'studyFirstSubmitQcDate': '2024-04-26', 'lastUpdatePostDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Endoscopy spared ratio', 'timeFrame': 'at end of the patient enrollment', 'description': 'the percentage of patients spared with endoscopy'}, {'measure': 'HRV missing ratio', 'timeFrame': 'at end of the patient enrollment', 'description': 'the percentage of patients missed with high-risk varices'}], 'primaryOutcomes': [{'measure': 'diagnostic performance', 'timeFrame': 'at end of the patient enrollment', 'description': 'sensitivity, specificity, positive predictive value, negative predictive value and accuracy of different diagnostic models'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['diagnostic model', 'high risk varices', 'iLivTouch'], 'conditions': ['Varices', 'Liver Cirrhosis']}, 'referencesModule': {'references': [{'pmid': '34713329', 'type': 'BACKGROUND', 'citation': 'Yan Y, Xing X, Wang X, Yang L. Liver stiffness by two-dimensional shear wave elastography for screening high-risk varices in patients with compensated advanced chronic liver disease. Eur Radiol. 2022 Mar;32(3):2078-2088. doi: 10.1007/s00330-021-08280-3. Epub 2021 Oct 29.'}, {'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': '28696510', 'type': 'BACKGROUND', 'citation': 'Augustin S, Pons M, Maurice JB, Bureau C, Stefanescu H, Ney M, Blasco H, Procopet B, Tsochatzis E, Westbrook RH, Bosch J, Berzigotti A, Abraldes JG, Genesca J. Expanding the Baveno VI criteria for the screening of varices in patients with compensated advanced chronic liver disease. Hepatology. 2017 Dec;66(6):1980-1988. doi: 10.1002/hep.29363. Epub 2017 Oct 30.'}, {'pmid': '33039403', 'type': 'BACKGROUND', 'citation': 'Wang H, Wen B, Chang X, Wu Q, Wen W, Zhou F, Guo Y, Ji Y, Gu Y, Lai Q, He Q, Li J, Chen J, Hou J. Baveno VI criteria and spleen stiffness measurement rule out high-risk varices in virally suppressed HBV-related cirrhosis. J Hepatol. 2021 Mar;74(3):584-592. doi: 10.1016/j.jhep.2020.09.034. Epub 2020 Oct 8.'}, {'pmid': '35120736', 'type': 'BACKGROUND', 'citation': 'de Franchis R, Bosch J, Garcia-Tsao G, Reiberger T, Ripoll C; Baveno VII Faculty. Baveno VII - Renewing consensus in portal hypertension. J Hepatol. 2022 Apr;76(4):959-974. doi: 10.1016/j.jhep.2021.12.022. Epub 2021 Dec 30.'}, {'pmid': '36356684', 'type': 'BACKGROUND', 'citation': 'Zhang X, Song J, Zhang Y, Wen B, Dai L, Xi R, Wu Q, Li Y, Luo X, Lan X, He Q, Luo W, Lai Q, Ji Y, Zhou L, Qi T, Liu M, Zhou F, Wen W, Li H, Liu Z, Chen Y, Zhu Y, Li J, Huang J, Cheng X, Tu M, Hou J, Wang H, Chen J. Baveno VII algorithm outperformed other models in ruling out high-risk varices in individuals with HBV-related cirrhosis. J Hepatol. 2023 Mar;78(3):574-583. doi: 10.1016/j.jhep.2022.10.030. Epub 2022 Nov 7.'}, {'pmid': '33939744', 'type': 'BACKGROUND', 'citation': 'Ng YZ, Lai LL, Wong SW, Mohamad SY, Chuah KH, Chan WK. Attenuation parameter and liver stiffness measurement using FibroTouch vs Fibroscan in patients with chronic liver disease. PLoS One. 2021 May 3;16(5):e0250300. doi: 10.1371/journal.pone.0250300. eCollection 2021.'}, {'pmid': '25880975', 'type': 'BACKGROUND', 'citation': 'Ou X, Wang X, Wu X, Kong Y, Duan W, Zhou J, Sun D, Wang Y, You H, Jia J. [Comparison of FibroTouch and FibroScan for the assessment of fibrosis in chronic hepatitis B patients]. Zhonghua Gan Zang Bing Za Zhi. 2015 Feb;23(2):103-6. doi: 10.3760/cma.j.issn.1007-3418.2015.02.006. Chinese.'}, {'pmid': '27788720', 'type': 'BACKGROUND', 'citation': 'Zeng J, Sun WL, Chen GY, Pan Q, Yan SY, Sun C, Xu ZJ, Fan JG. [Efficiency of FibroScan and FibroTouch in liver stiffness measurement and fat quantification: a comparative analysis]. Zhonghua Gan Zang Bing Za Zhi. 2016 Sep 20;24(9):652-658. doi: 10.3760/cma.j.issn.1007-3418.2016.09.004. Chinese.'}, {'pmid': '29729368', 'type': 'BACKGROUND', 'citation': 'Colecchia A, Ravaioli F, Marasco G, Colli A, Dajti E, Di Biase AR, Bacchi Reggiani ML, Berzigotti A, Pinzani M, Festi D. A combined model based on spleen stiffness measurement and Baveno VI criteria to rule out high-risk varices in advanced chronic liver disease. J Hepatol. 2018 Aug;69(2):308-317. doi: 10.1016/j.jhep.2018.04.023. Epub 2018 May 3.'}]}, 'descriptionModule': {'briefSummary': 'This is an observational ambispective cohort study to validate the Baveno VI guideline and develop a new diagnostic model to screen high-risk varices (HRV) of liver cirrhosis using iLivTouch.', 'detailedDescription': 'Esophageal variceal bleeding is a common and fatal complication in patients with liver cirrhosis. The diagnosis of high-risk varices (HRV) traditionally depends on gastroscopy, which is expensive and poorly tolerated with patients. Baveno VI guideline has put forward a HRV screening model based on liver stiffness and platelet count. This is an observational ambispective cohort study. The retrospective cohort is derived from the previous records of the hospital information system, and the prospective cohort is enrolled prospectively at the local research center when participants meet the inclusion criteria. The purpose of this study is to establish a diagnostic model of HRV in patients with liver cirrhosis according to the liver stiffness value measured by iLivTouch and other laboratory indexes, so as to verify the applicability of Baveno VI standard under the condition of iLivTouch and establish a cutoff value that is more suitable for iLivTouch. In addition, this study will try to find some new indexes to further improve the diagnostic efficiency of HRV. The minimum enrolment period is anticipated to be 6 months per center and will be extended if necessary to reach the overall study target.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with liver cirrhosis diagnosed by clinical or imaging diagnosis.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18-75;\n2. Patients with liver cirrhosis diagnosed by clinical or imaging diagnosis;\n3. The interval of iLivTouch and esophagogastroduodenoscopy is no more than 3 months;\n\nExclusion Criteria:\n\n1. the interval between esophagogastroduodenoscopy and iLivTouch is more than 3 months;\n2. any decompensation events (ascites, hepatic encephalopathy or gastroesophageal variceal bleeding) during endoscopy or iLivTouch examination, or during the interval between them;\n3. currently taking nonselective beta blocker/ antiplatelet / anticoagulant drugs;\n4. hepatocellular carcinoma;\n5. after transjugular intrahepatic portosystemic shunt surgery;\n6. after liver transplantation.\n7. portal-spleen-mesenteric venous thrombosis;\n8. patients with splenectomy;\n9. BMI ≥ 30;\n10. patients with acute active hepatitis or patients with cholestatic hepatitis;\n11. IQR/median of liver stiffness measurement \\> 30%.'}, 'identificationModule': {'nctId': 'NCT06392503', 'acronym': 'NID-HRV', 'briefTitle': 'Noninvasive Diagnosis Model for High-risk Varices in Cirrhosis', 'organization': {'class': 'OTHER', 'fullName': 'Beijing 302 Hospital'}, 'officialTitle': 'Establishment of Noninvasive Diagnosis Model for High-risk Varices in Cirrhosis Patients Based on iLivTouch', 'orgStudyIdInfo': {'id': 'KY-2023-10-59-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'retrospective cohort group', 'description': 'patients before the study started', 'interventionNames': ['Diagnostic Test: different diagnostic models']}, {'label': 'prospective cohort group', 'description': 'spatients after the study started', 'interventionNames': ['Diagnostic Test: different diagnostic models']}], 'interventions': [{'name': 'different diagnostic models', 'type': 'DIAGNOSTIC_TEST', 'description': 'the patients were screened by different diagnostic models', 'armGroupLabels': ['prospective cohort group', 'retrospective cohort group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100039', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Junliang Fu, MD', 'role': 'CONTACT', 'email': 'fjunliang@163.com', 'phone': '010-66933214'}], 'facility': 'the Fifth Medical Center, Chinese PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Fu junliang, PHD', 'role': 'CONTACT', 'email': 'fjunliang@163.com', 'phone': '010-66933214'}], 'overallOfficials': [{'name': 'Fu junliang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'the Fifth Medical Center, Chinese PLA General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'After enrollment and data analysis, the study results will be submitted to peer-reviewed journals for publication. Personal information about potential and enrolled participants will be strictly confidential to the public before, during, and after the study.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing 302 Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Qianfoshan Hospital', 'class': 'OTHER'}, {'name': 'First Hospital of China Medical University', 'class': 'OTHER'}, {'name': 'The Second Affiliated Hospital of Dalian Medical University', 'class': 'OTHER'}, {'name': 'Second Hospital of Jilin University', 'class': 'OTHER'}, {'name': 'Shengjing Hospital', 'class': 'OTHER'}, {'name': 'The Affiliated Hospital Of Guizhou Medical University', 'class': 'OTHER'}, {'name': 'The First Hospital of Yulin', 'class': 'UNKNOWN'}, {'name': 'LanZhou University', 'class': 'OTHER'}, {'name': "Chengdu Third People's Hospital", 'class': 'UNKNOWN'}, {'name': 'Tianjin Third Central Hospital', 'class': 'OTHER'}, {'name': "Second Affiliated Hospital of Xi'an Jiaotong University", 'class': 'OTHER'}, {'name': "People's Hospital of Lixin County", 'class': 'UNKNOWN'}, {'name': "The Fourth People's Hospital of Qinghai Province", 'class': 'OTHER'}, {'name': "The Fourth People's Hospital of Nanning", 'class': 'OTHER'}, {'name': "The Third People's Hospital of Taiyuan", 'class': 'OTHER'}, {'name': 'Central Hospital of Huludao', 'class': 'UNKNOWN'}, {'name': 'Jixi Infectious Diseases Hospital', 'class': 'UNKNOWN'}, {'name': 'First Affiliated Hospital of Jiamusi University', 'class': 'UNKNOWN'}, {'name': "Benxi Sixth People's Hospital", 'class': 'UNKNOWN'}, {'name': 'Yuncheng Central Hospital', 'class': 'OTHER'}, {'name': "The First People's Hospital of Zigong City, Sichuan Province", 'class': 'UNKNOWN'}, {'name': 'Second Affiliated Hospital of Guangzhou Medical University', 'class': 'OTHER'}, {'name': 'Ruikang Affiliated Hospital of Guangxi University of Chinese Medicine', 'class': 'UNKNOWN'}, {'name': "Guilin People's Hospital", 'class': 'UNKNOWN'}, {'name': 'Tianjin Binhai New Area Dagang Hospital', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}