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Effectiveness of Bariatric Surgery for NAFLD/NASH

RECRUITINGSponsored by Beijing Friendship Hospital
Actively Recruiting
SponsorBeijing Friendship Hospital
Started2020-04-21
Est. completion2024-12-31
Eligibility
Age16 Years – 65 Years
Healthy vol.Accepted

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.

Eligibility

Age: 16 Years – 65 YearsHealthy volunteers accepted
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 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.

Conditions4

Bariatric Surgery CandidateLiver DiseaseNAFLDNASH With Fibrosis

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