Effectiveness of Bariatric Surgery for NAFLD/NASH
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
| Condition(s) | Bariatric Surgery Candidate, NAFLD, NASH With Fibrosis |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | 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 participate | Inclusion Criteria: \[For Base-NAFLD\] 1. Age between 16 and 65 years (all sexes). 2. 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. 3. 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. \[For Base-NASH\] 1. Age between 16 and 65 years (all sexes). 2. 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. 3. Histologically confirmed NASH with fibrosi |
| Ages | 16 Years to 65 Years |
| Sex | All |
| Lead sponsor | Beijing Friendship Hospital |
| Locations | Beijing, Beijing Municipality, China |
| Start date | 2020-04-21 |
| NCT ID | NCT04366999 |
| Official listing | https://clinicaltrials.gov/study/NCT04366999 |