[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100570429":3},{"organization":4,"outcomesModule":7,"designInfo":58,"detailedDescription":61,"studyPopulation":62,"armGroups":63,"interventions":69,"overallOfficials":57,"centralContacts":75,"locations":85,"responsibleParty":106,"collaborators":57,"id":110,"slug":57,"hasResults":111,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":57,"eligibilityCriteria":115,"healthyVolunteers":111,"sex":116,"minAge":117,"maxAge":118,"enrollmentInfo":119,"targetDuration":122,"studyType":123,"phases":57,"briefSummary":124,"conditions":125,"keywords":127,"overallStatus":88,"whyStopped":57,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":142},{"fullName":5,"class":6},"Beijing Municipal Administration of Hospitals","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":57},[9],{"measure":10,"description":11,"timeFrame":12},"Reversal of NASH liver fibrosis","Reversal of NASH liver fibrosis based on liver biopsy definition","12 months",[14,17,20,23,25,27,29,31,34,36,38,40,42,44,46,48,51,54],{"measure":15,"description":16,"timeFrame":12},"Changes in LSM value","Changes in liver stiffness value (LSM value) detected by instantaneous liver elasticity testing",{"measure":18,"description":19,"timeFrame":12},"Changes in liver fat content","Instantaneous liver elasticity detection of changes in liver fat content (CAP value)",{"measure":21,"description":22,"timeFrame":12},"The dynamic changes of existing non-invasive evaluation models for fibrosis","The dynamic changes of existing non-invasive evaluation models for fibrosis include: APRI=AST(ULN)\u002FPLT(10\\^9\u002FL)×100",{"measure":21,"description":24,"timeFrame":12},"The dynamic changes of existing non-invasive evaluation models for fibrosis include:\n\nFIB-4: Age, AST, ALT, platelets",{"measure":21,"description":26,"timeFrame":12},"The dynamic changes of existing non-invasive evaluation models for fibrosis include:\n\nBARD：BMI ≥28, AST\u002FALT ≥0.8, diabetes",{"measure":21,"description":28,"timeFrame":12},"The dynamic changes of existing non-invasive evaluation models for fibrosis include:\n\nNAFLD Fibrosis Score",{"measure":21,"description":30,"timeFrame":12},"The dynamic changes of existing non-invasive evaluation models for fibrosis include:\n\nFAST",{"measure":32,"description":33,"timeFrame":12},"Dynamic changes in metabolic indicators of NAFLD","Dynamic changes in metabolic indicators of NAFLD, including BMI;",{"measure":32,"description":35,"timeFrame":12},"Dynamic changes in metabolic indicators of NAFLD, including body fat percentage;",{"measure":32,"description":37,"timeFrame":12},"Dynamic changes in metabolic indicators of NAFLD, including blood pressure;",{"measure":32,"description":39,"timeFrame":12},"Dynamic changes in metabolic indicators of NAFLD, including sugar;",{"measure":32,"description":41,"timeFrame":12},"Dynamic changes in metabolic indicators of NAFLD, including glycated hemoglobin;",{"measure":32,"description":43,"timeFrame":12},"Dynamic changes in metabolic indicators of NAFLD, including fasting insulin;",{"measure":32,"description":45,"timeFrame":12},"Dynamic changes in metabolic indicators of NAFLD, including uric acid;",{"measure":32,"description":47,"timeFrame":12},"Dynamic changes in metabolic indicators of NAFLD, including blood lipid series;",{"measure":49,"description":50,"timeFrame":12},"The occurrence of cirrhosis","The occurrence of cirrhosis: that is, when the liver biopsy did not indicate cirrhosis at the time of enrollment, cirrhosis occurred during follow-up.",{"measure":52,"description":53,"timeFrame":12},"The occurrence of liver outcome events","The occurrence of liver outcome events: decompensation of cirrhosis (ascites, rupture of esophageal and gastric varices) Blood, hepatic encephalopathy, hepatocellular carcinoma, liver related deaths\u002Fliver transplantation.",{"measure":55,"description":56,"timeFrame":12},"Extrahepatic related events","Extrahepatic related events: cardiovascular and cerebrovascular events, extrahepatic malignant tumors, and newly developed metabolic diseases.",null,{"allocation":57,"interventionModel":57,"interventionModelDescription":57,"primaryPurpose":57,"observationalModel":59,"timePerspective":60,"maskingInfo":57},"COHORT","PROSPECTIVE","Confirmed NAFLD patients were enrolled, and those with NASH and fibrosis F2-4 stages confirmed by liver biopsy were selected, and clinical and pathological data were collected for relevant evaluation and definition. A NASH \"fibrosis reversal\" pathological evaluation system was established based on the new standard, and an alternative non-invasive indicator and observation index were established based on the reversal standard.","Patients diagnosed with NAFLD were enrolled, and patients with NASH and fibrosis stage F2-4 confirmed by liver biopsy were screened",[64],{"label":65,"type":57,"description":66,"interventionNames":67},"Case group","After successful patient screening and enrollment, visits will be conducted every 6 months to collect the following information: Physical examination, accompanying diseases, hematology: blood routine, coagulation function, serology, imaging, body fat measurement, liver puncture information (if applicable). Lifestyle questionnaire: Dietary characteristics, sleep\u002Fwake time, daily sitting time, exercise duration, exercise mode. Health education and lifestyle intervention guidance should be provided to patients based on exercise mode. When adjusting lifestyle for at least 1 year and no more than 3 years, a second liver biopsy should be performed to evaluate liver histological changes.",[68],"Other: life-style",[70],{"type":71,"name":72,"description":73,"armGroupLabels":74,"otherNames":57},"OTHER","life-style","The patients were given health education and lifestyle intervention guidance, followed by lifestyle adjustment for at least 1 year and no more than 3 years, and a second liver biopsy was performed to evaluate liver histological changes.",[65],[76,81],{"name":77,"role":78,"phone":79,"phoneExt":57,"email":80},"Minghui Li","CONTACT","+8613693259096","wuhm2000@sina.com",{"name":82,"role":78,"phone":83,"phoneExt":57,"email":84},"Weihua Cao","+8618811333129","weihuacaohappy@163.com",[86],{"facility":87,"status":88,"city":89,"state":90,"zip":91,"country":92,"countryCode":93,"cosmosGeoPoint":94,"geoPoint":99,"contacts":100},"Beijing Ditan Hospital, Capital Medical University","RECRUITING","Beijing","Beijing Municipality","100015","China","CN",{"type":95,"coordinates":96},"Point",[97,98],116.39723,39.9075,{"lat":98,"lon":97},[101,103],{"name":102,"role":78,"phone":79,"phoneExt":57,"email":80},"Minghui Li, Dr",{"name":104,"role":78,"phone":105,"phoneExt":57,"email":84},"Weihua Cao, Dr","+8618811333139",{"type":107,"investigatorFullName":77,"investigatorTitle":108,"investigatorAffiliation":109,"oldNameTitle":57,"oldOrganization":57},"PRINCIPAL_INVESTIGATOR","Director and Professor of Hepatology Department 2","Beijing Ditan Hospital","100570429",false,"NCT06707129","Establishment of Precise Histological Evaluation Criteria for NASH Fibrosis Reversal","Establishment of Precise Histological Evaluation Criteria for Reversal of NASH Fibrosis","Inclusion Criteria:\n\n* Aged between 18 and 70 years at the time of liver biopsy;\n* Gender is not limited;\n* Hepatic perforation suggested that NASH complicated with fibrosis stage F2-4;\n* Signed written informed consent.\n\nExclusion Criteria:\n\n* Combined HCV infection, HIV infection, alcoholic liver disease, autoimmune liver disease, genetic metabolic liver disease Disease, drug-induced liver injury and other chronic liver diseases;\n* Women during pregnancy;\n* There are the following conditions before liver perforation: HCC or possible HCC (imaging suggests malignant liver occupation); decompensation of cirrhosis (ascites, hepatic encephalopathy, gastrointestinal bleeding, hepatorenal syndrome, etc.); Patients with other malignant tumors; Recipients of liver transplantation;\n* Patients considered by the investigator to be unsuitable for this study.","ALL","18 Years","70 Years",{"count":120,"type":121},50,"ESTIMATED","12 Months","OBSERVATIONAL","Collect confirmed cases of NAFLD patients and enroll them in the study. Select patients with NASH and fibrosis stage F2-4 confirmed by liver biopsy, and collect clinical and pathological data for relevant evaluation and definition. Establish a NASH \"fibrosis reversal\" pathological evaluation system, based on a new reversal standard, establish non-invasive alternative indicators, and observe indicators.",[126],"Non-alcoholic Fatty Liver Disease",[128,129,130,131,132],"non-alcoholic fatty liver disease","nonalcoholic steatohepatitis","liver biopsy","Fibrosis reversal","histopathology","2024-11-23",{"date":135,"type":136},"2024-11-27","ACTUAL",{"date":138,"type":136},"2024-08-01",{"date":140,"type":121},"2027-08-31",{"name":5,"class":6},1]