Ignite Creation Date:
2025-12-24 @ 5:06 PM
Ignite Modification Date:
2026-01-01 @ 9:55 PM
Study NCT ID:
NCT04640350
Status:
UNKNOWN
Last Update Posted:
2021-01-19
First Post:
2020-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risk Prediction of Bleeding in Liver Cirrhosis by Combi-elastography
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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2023-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-13', 'studyFirstSubmitDate': '2020-11-10', 'studyFirstSubmitQcDate': '2020-11-19', 'lastUpdatePostDateStruct': {'date': '2021-01-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'F index', 'timeFrame': 'baseline', 'description': 'F index is linked to the degree of liver fibrosis,and it can be available by ultrasound elastography checking.'}, {'measure': 'A index', 'timeFrame': 'baseline', 'description': 'A index is linked to the degree of hepatitis ,and it can be available by ultrasound elastography checking.'}, {'measure': 'Spleen stiffness', 'timeFrame': 'baseline', 'description': 'Spleen stiffness can be available by ultrasound elastography checking.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Elasticity Imaging Techniques', 'Ultrasound'], 'conditions': ['Liver Cirrhosis', 'Gastroesophageal Varices', 'Variceal Hemorrhage']}, 'descriptionModule': {'briefSummary': 'Through the parameters of liver stiffness and spleen stiffness obtained by combi-elastography technique, summarize and analyze the warning index of esophagogastric variceal bleeding in patients with cirrhosis, so as to provide a new and valuable technique for clinical diagnosis.', 'detailedDescription': 'Firstly,the combi-elastography technique developed by HITACHI uses the method of multi-index and multi-parameter to evaluate the liver stiffness and spleen stiffness comprehensively.\n\nAnd then,this prospective study is designed to follow up patients with cirrhosis for a period of 12 months, summarize and analyze the warning index of bleeding in patients with cirrhosis,so as to provide a new and valuable technique for clinical diagnosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with liver cirrhosis and the gastroscopy is in line with the indications of portal hypertension.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-80 years old, no gender limit;\n* The clinical diagnosis is in line with patients with liver cirrhosis caused by chronic hepatitis B, and the gastroscopy is in line with the indications of portal hypertension;\n* Gastroscopy needs to provide the degree of gastroesophageal varices;\n* Sign the informed consent form.\n\nExclusion Criteria:\n\n* Patients with cirrhosis and portal hypertension because of other causes or combined with other causes(such as viral hepatitis other than hepatitis B,Autoimmune liver disease, alcoholic liver disease, metabolism-related fatty liver disease, etc.)\n* Patients with a history of spleen-related operations, such as splenectomy, splenic embolism;\n* Patients undergoing portosystemic shunt or TIPS;\n* Isolated esophageal venous tumor and its bleeding patients;\n* History of upper gastrointestinal tumor or bleeding from gastric ulcer , etc;\n* Those with serious diseases of other systems that cannot cooperate with elastography examination, such as heart failure, renal failure, mental illness, etc;\n* Ascites before liver and spleen result unable to complete elasticity examination;\n* Pregnant patients.'}, 'identificationModule': {'nctId': 'NCT04640350', 'briefTitle': 'Risk Prediction of Bleeding in Liver Cirrhosis by Combi-elastography', 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'officialTitle': 'Risk Prediction of Bleeding in Liver Cirrhosis by Combi-elastography', 'orgStudyIdInfo': {'id': 'S2020-387-02'}}, 'contactsLocationsModule': {'locations': [{'zip': '100853', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ping Liang, Doctor', 'role': 'CONTACT'}], 'facility': 'Chinese PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Jie Yu, Doctor', 'role': 'CONTACT', 'email': 'yu-jie301@hotmail.com', 'phone': '010-66937981'}], 'overallOfficials': [{'name': 'Ping Liang, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese PLA General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief physician', 'investigatorFullName': 'Ping Liang', 'investigatorAffiliation': 'Chinese PLA General Hospital'}}}}