Effectiveness of bariatric surgery for patients with liver disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study investigates the effectiveness of bariatric surgery in obese patients diagnosed with non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) with fibrosis. It aims to compare the outcomes of different surgical techniques, including sleeve gastrectomy, Roux-en-Y gastric bypass, and one anastomosis gastric bypass. The study began in 2020 with a cohort of patients and plans to expand with a secondary cohort in 2024. The focus is on assessing histological remission of liver disease post-surgery.

Why it matters

Who can join: the full rules

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.

Where it's running

• Beijing Friendship Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Principal investigator: Zhongtao Zhang, M.D.;Ph.D. — Beijing Friendship Hospital
• Study coordinator: Zhongtao Zhang, M.D.;Ph.D.
• Email: zhangzht@ccmu.edu.cn
• Phone: +86-13801060364

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.