Effectiveness of Bariatric Surgery for NAFLD/NASH

Last updated: May 10, 2024
Sponsor: Beijing Friendship Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Primary Biliary Cholangitis

Scar Tissue

Liver Disease

Treatment

OAGB

SG

RYGB

Clinical Study ID

NCT04366999
Base-NAFLD/NASH
  • Ages 16-65
  • All Genders

Study 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 Criteria

Inclusion

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 forobesity in Asian populations and scheduled for a primary bariatric surgery at theparticipating centres.

  3. Diagnosed with hepatic steatosis preoperatively by radiologic (includingultrasonography, magnetic resonance imaging [MRI]-derived proton density fatfraction [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 forobesity in Asian populations and scheduled for a primary bariatric surgery at theparticipating 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

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 alcoholconsumption 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 causingfatty 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 withsignature.

Study Design

Total Participants: 320
Treatment Group(s): 3
Primary Treatment: OAGB
Phase:
Study Start date:
April 21, 2020
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Beijing Friendship Hospital

    Beijing, Beijing 100050
    China

    Active - Recruiting

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