Effectiveness of Bariatric Surgery for NAFLD/NASH

Launched by BEIJING FRIENDSHIP HOSPITAL · Apr 26, 2020

Keywords

ClinConnect Summary

This clinical trial is studying how effective bariatric surgery (a type of weight loss surgery) is for people who have obesity and a liver condition called NAFLD (non-alcoholic fatty liver disease) or NASH (non-alcoholic steatohepatitis) with fibrosis (scarring of the liver). The goal is to compare different types of surgeries, such as sleeve gastrectomy, Roux-en-Y gastric bypass, and one-anastomosis gastric bypass, to see which one works best in improving liver health. The study began in 2020 and will continue to gather information until May 2024.

To be eligible for this study, participants need to be between 16 and 65 years old, diagnosed with obesity, and scheduled for a primary bariatric surgery. They must also have a confirmed liver condition either through imaging tests or liver biopsy results. However, individuals who have had previous bariatric surgery, certain medical conditions, or those with a history of excessive alcohol use are not eligible to participate. If you join the study, you can expect to contribute to important research that could help improve treatment options for liver disease in people with obesity.

Gender

ALL

Eligibility criteria

• 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.