Effectiveness of Bariatric Surgery for NAFLD/NASH
Recruiting · NCT04366999 · Observational (researchers observe without assigning treatment) · Lead sponsor: Beijing Friendship Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- \[For Base-NAFLD\]
- 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 criteria
- any patient who had previously been submitted to any type of bariatric 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.;
- previous major gastrointestinal surgery；
- 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.
Where it is running
1 location listed.
- Beijing Friendship Hospital - Beijing, Beijing Municipality, China