Effectiveness of Bariatric Surgery for NAFLD/NASH

Recruiting now

Conditions studied: Bariatric Surgery Candidate, NAFLD, NASH With Fibrosis

In brief

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.

Key facts

Study ID

NCT04366999

Run by

Beijing Friendship Hospital

People needed

320

Starts

2020-04-21

Expected to finish

2026-12-31

Last updated by the study team

2024-05-14

Who can join

Age: 16 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• [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

You may not qualify if…

• 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

• Beijing Friendship Hospital — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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