Effectiveness of Bariatric Surgery for Nonalcoholic Fatty Liver Diseases/Nonalcoholic Steatohepatitis With Fibrosis : A Prospective, Multicentric Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- the remisson rate of NAFLD (for Base-NAFLD cohort)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •[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
排除标准
- •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.
结局指标
主要结局
the remisson rate of NAFLD (for Base-NAFLD cohort)
时间窗: 1 years after surgery
Percentage of liver fat content \<5% of abdominal magnetic resonance imaging(MRI) at 1 year after surgery. Visit : Post-op 12 months (±30 Days)
Histological remission of NASH without worsening of fibrosis (for Base-NASH cohort)
时间窗: 1 years after surgery
\*NASH resolution was defined as presence of a CRN inflammation score of 0 or 1 and no hepatocyte ballooning (score of 0). \*\*Worsening of fibrosis was defined as an increase of one stage or more on the NASH-CRN fibrosis score at 1-year follow-up.
次要结局
- the rate of fibrosis improvement without NASH worsening(1 year after surgery)
- changes in NASH and liver fbrosis biopsy fndings(1 year after surgery)
- changes in body weight(3 months, 6 months, and 1 year after surgery)
- resolution of obesity-related comorbidities(1 year after surgery)
- incidence of adverse health events(1 year after surgery)
研究者
Zhongtao Zhang
Director of general surgery, principal investigator
Beijing Friendship Hospital