Effectiveness of Bariatric Surgery for NAFLD/NASH

Recruiting

• Conditions: NAFLD; NASH With Fibrosis; Bariatric Surgery Candidate
• Interventions: Procedure: OAGB; Procedure: RYGB; Procedure: SG

• 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

Arm && Interventions

Group	Intervention	Description
OAGB	OAGB	In this group, the bariatric procedure is one anastomosis gastric bypass(OAGB), all operations follow the same standard operating procedure.
RYGB	RYGB	In this group, the bariatric procedure is Roux-en-Y gastric bypass (RYGB), all operations follow the same standard operating procedure.
SG	SG	In this group, the bariatric procedure is sleeve gastrectomy (SG), all operations follow the same standard operating procedure.

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