Effectiveness of Bariatric Surgery for NAFLD/NASH
Key facts
- Where
- Beijing, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 16 and 65 years old?
Source: NCT04366999, who can take part
Where in China
- Beijing Friendship HospitalBeijing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Beijing Friendship Hospital
- Trial code
- NCT04366999
- Record updated
- 14 May 2024
- Original description
This is a prospective, multicenter cohort study, which subjects were obese patients requiring bariatric surgery.Read full original descriptionShow less
Effectiveness of Bariatric Surgery for Nonalcoholic Fatty Liver Diseases/Nonalcoholic Steatohepatitis With Fibrosis : A Prospective, Multicentric Cohort Study
This is a prospective, multicenter cohort study, which subjects were obese patients requiring bariatric surgery.
This study aims to explore the the effectiveness of bariatric surgery for NAFLD/NASH 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/NASH.
The 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.
Inclusion: [For Base-NAFLD]; Age between 16 and 65 years (all sexes); 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; 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; [For Base-NASH]; Age between 16 and 65 years (all sexes); 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; Histologically confirmed NASH with fibrosis:; NAFLD activity score(NAS) ≥4 with at least 1 in each single item and NASH-CRN fibrosis stage ≥F1.
Exclusion: any patient who had previously been submitted to any type of bariatric surgery; previous major gastrointestinal surgery；; history of excessive drinking: in the past 12 months, the male equivalent of alcohol consumption more than 30g/d, and the female more than 20g/d; history of taking amiodarone, methotrexate, tamoxifen, glucocorticoids, etc.；; 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; diagnosed or suspected malignancy；; poorly controlled significant medical or psychiatric disorders；; disorders such as a medical history of major pathology; can not be able to understand and willing to participate in this registry with signature.