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Clinical Trials/NCT04366999
NCT04366999RecruitingNot Applicable

Effectiveness of Bariatric Surgery for Nonalcoholic Fatty Liver Diseases/Nonalcoholic Steatohepatitis With Fibrosis : A Prospective, Multicentric Cohort Study

Beijing Friendship Hospital1 site in 1 country320 target enrollmentStarted: April 21, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
320
Locations
1
Primary Endpoint
the remisson rate of NAFLD (for Base-NAFLD cohort)

Study Overview

Brief 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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
16 Years to 65 Years (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • [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

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.

Outcomes

Primary Outcomes

the remisson rate of NAFLD (for Base-NAFLD cohort)

Time Frame: 1 years after surgery

Percentage of liver fat content \<5% of abdominal magnetic resonance imaging(MRI) at 1 year after surgery. Visit : Post-op 12 months (±30 Days)

Histological remission of NASH without worsening of fibrosis (for Base-NASH cohort)

Time Frame: 1 years after surgery

\*NASH resolution was defined as presence of a CRN inflammation score of 0 or 1 and no hepatocyte ballooning (score of 0). \*\*Worsening of fibrosis was defined as an increase of one stage or more on the NASH-CRN fibrosis score at 1-year follow-up.

Secondary Outcomes

  • the rate of fibrosis improvement without NASH worsening(1 year after surgery)
  • changes in NASH and liver fbrosis biopsy fndings(1 year after surgery)
  • changes in body weight(3 months, 6 months, and 1 year after surgery)
  • resolution of obesity-related comorbidities(1 year after surgery)
  • incidence of adverse health events(1 year after surgery)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Zhongtao Zhang

Director of general surgery, principal investigator

Beijing Friendship Hospital

Study Sites (1)

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