Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-26 @ 1:08 AM
Study NCT ID:
NCT04850534
Status:
COMPLETED
Last Update Posted:
2023-12-06
First Post:
2021-04-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Systemic Inflammation in Liver Cirrhosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-05', 'studyFirstSubmitDate': '2021-04-18', 'studyFirstSubmitQcDate': '2021-04-18', 'lastUpdatePostDateStruct': {'date': '2023-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Upper Gastrointestinal Bleeding', 'timeFrame': 'One Year', 'description': 'Overt upper GI bleeding due to esophagogastric varices, ulcers and other causes; Identified by clinical manifestations, lab tests and endoscopy and measured by number/proportion of patients'}, {'measure': 'Death', 'timeFrame': 'One Year', 'description': 'Deaths caused by variceal bleeding, hepatocellular carcinoma, liver failure, etc'}], 'secondaryOutcomes': [{'measure': 'New or worsening acute decompensation event other than upper GI bleeding', 'timeFrame': 'One Year', 'description': 'Ascites, Hepatic encephalopathy, systemic infection, spontaneous bacterial peritonitis, hepatorenal syndrome, etc Identified by clinical manifestations, lab tests and images according to renown practice guidelines and measured by number/proportion of patients'}, {'measure': 'Liver transplantation/ Transfer to other non-endoscopic therapies', 'timeFrame': 'One Year', 'description': 'Undergo liver transplantation, or transferred to surgical, radio-interventional, or other non-endoscopic therapies; Measured by number/proportion of patients'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Liver cirrhosis; Systemic inflammation'], 'conditions': ['Liver Cirrhosis']}, 'descriptionModule': {'briefSummary': 'Investigate systemic inflammation in liver cirrhosis patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients of liver cirrhosis with high-risk bleeding esophaogastric varices', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Decompensated liver cirrhosis, with endoscopy-verified high-risk esophagogastric varices;\n2. Adult patients aged 18-75 years;\n3. Willing to anticipate and informed consent form obtained\n\nExclusion Criteria:\n\n1. History of prior radio-interventional therapy (TIPS or BRTO), liver transplantation, splenectomy, or hepatectomy;\n2. Non-sinusoidal cirrhosis (e.g. vascular cirrhosis);\n3. Coexistence with advanced hepatocellular carcinoma or other malignancies;\n4. Coexistence with severe systemic diseases and less than 3 months of expected survival time;\n5. Acute infection within 4 weeks before recruitment;\n6. Antibiotic use within 4 weeks before recruitment;\n7. Initial antiviral therapy for HBV or HCV within 4 weeks before recruitment;\n8. Pregnant or lactating women;\n9. Patients resistant to long-term follow-up'}, 'identificationModule': {'nctId': 'NCT04850534', 'acronym': 'SILC', 'briefTitle': 'Systemic Inflammation in Liver Cirrhosis', 'organization': {'class': 'OTHER', 'fullName': 'Third Affiliated Hospital, Sun Yat-Sen University'}, 'officialTitle': 'Evaluation and Prognostic Indications of Systemic Inflammation in Liver Cirrhosis Patients', 'orgStudyIdInfo': {'id': 'SILC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'EGD+NSBB', 'description': 'Patients receiving both endoscopic therapy and non-selective beta-blockers for treating high-risk esophagogastric varices'}, {'label': 'EGD', 'description': 'Patients receiving mono endoscopic therapy for treating high-risk esophagogastric varices'}]}, 'contactsLocationsModule': {'locations': [{'zip': '510630', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Department of Cardiology, the Third Affiliated Hospital, Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Bin Wu, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Gastroenterology, Third Affiliated Hospital of Sun Yar-sen University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Third Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Natural Science Foundation of China', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Jinlai Liu', 'investigatorAffiliation': 'Third Affiliated Hospital, Sun Yat-Sen University'}}}}