Effectiveness of Bariatric Surgery for NAFLD/NASH

Recruiting

• Conditions: NAFLD; NASH With Fibrosis; Bariatric Surgery Candidate

• Registration Number: NCT04366999
• Lead Sponsor: Beijing Friendship Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-21
• Study First Submitted: 2020-04-21
• Study First Submitted QC: 2020-04-26
• Study First Posted: 2020-04-29
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-10
• Last Update Posted: 2024-05-14
• Primary Completion: 2024-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 320

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the remisson rate of NAFLD (for Base-NAFLD cohort)	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)	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 Outcome Measures

Name	Time	Method
the rate of fibrosis improvement without NASH worsening	1 year after surgery	NASH worsening, was defined as an increase of ≥1 point in either the lobular inflammation score or the hepatocyte ballooning score.
changes in NASH and liver fbrosis biopsy fndings	1 year after surgery	2．including the NAS (NAFLD activity score) and SAF scores (steatosis \[S\], activity \[A\], and fbrosis \[F\]) .
changes in body weight	3 months, 6 months, and 1 year after surgery	1. percent excess weight loss (%EWL): %EWL=(\[initial weight\] - \[postoperative weight\])/(\[initial weight\] - \[ideal weight\]) (idealweight is defned as a body mass index \[BMI\] of 25 kg/m2 at each follow-up point); 2. percentage of total weight loss (%TWL): %TWL=(\[initial weight\] - \[postoperative weight\])/(\[initial weight\])×100
resolution of obesity-related comorbidities	1 year after surgery	4．blood glucose levels, lipid levels, and liver enzyme levels.
incidence of adverse health events	1 year after surgery	Including but not limited to bleeding, ulcer, intestinal obstruction etc.

Trial Locations

Locations (1)

Beijing Friendship Hospital; 🇨🇳 Beijing, Beijing, China