Image

Effectiveness of Bariatric Surgery for NAFLD/NASH

Effectiveness of Bariatric Surgery for NAFLD/NASH

Recruiting
16-65 years
All
Phase N/A

Powered by AI

Overview

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

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.

Study details
    Bariatric Surgery Candidate
    NAFLD
    NASH With Fibrosis

NCT04366999

Beijing Friendship Hospital

21 May 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.