[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100390674":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":35,"centralContacts":39,"locations":48,"responsibleParty":65,"collaborators":68,"id":90,"slug":91,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":10,"eligibilityCriteria":96,"healthyVolunteers":92,"sex":97,"minAge":98,"maxAge":99,"enrollmentInfo":100,"targetDuration":10,"studyType":103,"phases":10,"briefSummary":104,"conditions":105,"keywords":109,"overallStatus":50,"whyStopped":10,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"Beijing Friendship Hospital","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"SG",null,"In this group, the bariatric procedure is sleeve gastrectomy (SG), all operations follow the same standard operating procedure.",[13],"Procedure: SG",{"label":15,"type":10,"description":16,"interventionNames":17},"RYGB","In this group, the bariatric procedure is Roux-en-Y gastric bypass (RYGB), all operations follow the same standard operating procedure.",[18],"Procedure: RYGB",{"label":20,"type":10,"description":21,"interventionNames":22},"OAGB","In this group, the bariatric procedure is one anastomosis gastric bypass(OAGB), all operations follow the same standard operating procedure.",[23],"Procedure: OAGB",[25,29,32],{"type":26,"name":9,"description":27,"armGroupLabels":28,"otherNames":10},"PROCEDURE","SG involved a vertical gastric resection beginning 4-6 cm from the pylorus and ending 1-2 cm from the His angle, using linear staplers with the guidance of a 36 French intragastric bougie.",[9],{"type":26,"name":15,"description":30,"armGroupLabels":31,"otherNames":10},"RYGB entails the creation of a 15-30 mL (approximate) gastric pouch, a 150 cm Roux limb, and a 50 cm biliopancreatic limb.",[15],{"type":26,"name":20,"description":33,"armGroupLabels":34,"otherNames":10},"OAGB entails the creation of a long gastric tube by beginning 2 cm below the angular incisure starting from the lesser curvature side and then divided vertically upward by linear cutting staplers as calibrated with a 36 French bougie, followed by the creation of a single gastrojejunal anastomosis with an afferent biliopancreatic limb of 200 cm.",[20],[36],{"name":37,"affiliation":5,"role":38},"Zhongtao Zhang, M.D.;Ph.D.","PRINCIPAL_INVESTIGATOR",[40,44],{"name":37,"role":41,"phone":42,"phoneExt":10,"email":43},"CONTACT","+86-13801060364","zhangzht@ccmu.edu.cn",{"name":45,"role":41,"phone":46,"phoneExt":10,"email":47},"Mengyi Li, M.D.;Ph.D.","+86-15810993198","limengyi@ccmu.edu.cn",[49],{"facility":5,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"RECRUITING","Beijing","Beijing Municipality","100050","China","CN",{"type":57,"coordinates":58},"Point",[59,60],116.39723,39.9075,{"lat":60,"lon":59},[63,64],{"name":37,"role":41,"phone":42,"phoneExt":10,"email":43},{"name":37,"role":38,"phone":10,"phoneExt":10,"email":10},{"type":38,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Zhongtao Zhang","Director of general surgery, principal investigator",[69,71,74,76,78,80,82,84,86,88],{"name":70,"class":6},"Beijing Tiantan Hospital",{"name":72,"class":73},"Beijing Hospital (only for Base-NAFLD)","UNKNOWN",{"name":75,"class":6},"Beijing Shijitan Hospital, Capital Medical University",{"name":77,"class":73},"Shanghai Jiao Tong University affiliated Sixth People's Hospital Beijing Hospital (only for Base-NAFLD)",{"name":79,"class":73},"Huashan Hospital, Fudan University Beijing Hospital (only for Base-NAFLD)",{"name":81,"class":6},"Beijing Chao Yang Hospital",{"name":83,"class":6},"Capital Medical University",{"name":85,"class":73},"The First Hospital of Kunming",{"name":87,"class":73},"Bishan Hospital of Chongqiang Medical University",{"name":89,"class":6},"The First Hospital of Hebei Medical University","100390674","effectiveness-of-bariatric-surgery-for-nafldnash-100390674",false,"NCT04366999","Effectiveness of Bariatric Surgery for NAFLD\u002FNASH","Effectiveness of Bariatric Surgery for Nonalcoholic Fatty Liver Diseases\u002FNonalcoholic Steatohepatitis With Fibrosis : A Prospective, Multicentric Cohort Study","Inclusion Criteria:\n\n\\[For Base-NAFLD\\]\n\n1. Age between 16 and 65 years (all sexes).\n2. Diagnosed with obesity according to the World Health Organization criteria for obesity in Asian populations and scheduled for a primary bariatric surgery at the participating centres.\n3. Diagnosed with hepatic steatosis preoperatively by radiologic (including ultrasonography, magnetic resonance imaging \\[MRI\\]-derived proton density fat fraction \\[PDFF\\]) or pathologic(intraoperative hepatic pathology) examinations.\n\n\\[For Base-NASH\\]\n\n1. Age between 16 and 65 years (all sexes).\n2. Diagnosed with obesity according to the World Health Organization criteria for obesity in Asian populations and scheduled for a primary bariatric surgery at the participating centres.\n3. Histologically confirmed NASH with fibrosis:\n\nNAFLD activity score(NAS) ≥4 with at least 1 in each single item and NASH-CRN fibrosis stage ≥F1\n\nExclusion Criteria:\n\n* any patient who had previously been submitted to any type of bariatric surgery;\n* history of excessive drinking: in the past 12 months, the male equivalent of alcohol consumption more than 30g\u002Fd, and the female more than 20g\u002Fd;\n* history of taking amiodarone, methotrexate, tamoxifen, glucocorticoids, etc.；\n* history of specific diseases: Gene type 3 hepatitis C virus (HCV) infection, hepatolenticular degeneration, autoimmune hepatitis, total parenteral nutrition, lack of beta lipoproteinemia, congenital lipid atrophy, celiac disease which causing fatty liver, etc.;\n* previous major gastrointestinal surgery；\n* diagnosed or suspected malignancy；\n* poorly controlled significant medical or psychiatric disorders；\n* disorders such as a medical history of major pathology;\n* can not be able to understand and willing to participate in this registry with signature.","ALL","16 Years","65 Years",{"count":101,"type":102},320,"ESTIMATED","OBSERVATIONAL","This is a prospective, multicenter cohort study, which subjects were obese patients requiring bariatric surgery.\n\nThis study aims to explore the the effectiveness of bariatric surgery for NAFLD\u002FNASH with fribrosis, to explore the differences in the effectiveness among sleeve gastrostomy \\[SG\\], Roux-en-Y gastric bypass \\[RYGB\\], or one anastomosis gastric bypass \\[OAGB\\], and to explore the independent effectiveness of bariatric surgery in histological remission of NAFLD\u002FNASH.\n\nThe first stage of the cohort was started in 2020, named Base-NAFLD; In May 2024, based on Base-NAFLD, we plan to continue established a secondary cohort, named Base-NASH.",[106,107,108],"Bariatric Surgery Candidate","NAFLD","NASH With Fibrosis",[110,107,111,112,113],"Bariatric surgery","NASH","Fibrosis","Obesity","2024-05-10",{"date":116,"type":117},"2024-05-14","ACTUAL",{"date":119,"type":117},"2020-04-21",{"date":121,"type":102},"2026-12-31",{"name":5,"class":6},1]