Clinical trial NCT04366999: Effectiveness of Bariatric Surgery for NAFLD/NASH
Official title: Effectiveness of Bariatric Surgery for Nonalcoholic Fatty Liver Diseases/Nonalcoholic Steatohepatitis With Fibrosis : A Prospective, Multicentric Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bariatric Surgery Candidate
NAFLD
NASH With Fibrosis
Keywords: Bariatric surgery
NAFLD
NASH
Fibrosis
Obesity
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Tiantan Hospital
name: Beijing Hospital (only for Base-NAFLD)
name: Beijing Shijitan Hospital, Capital Medical University Beijing Hospital (only for Base-NAFLD)
name: Shanghai Jiao Tong University affiliated Sixth People's Hospital Beijing Hospital (only for Base-NAFLD)
name: Huashan Hospital, Fudan University Beijing Hospital (only for Base-NAFLD)
name: Beijing Chao Yang Hospital
name: Capital Medical University
name: The First Hospital of Kunming
name: Bishan Hospital of Chongqiang Medical University
name: The First Hospital of Hebei Medical University
First posted: 2020-04-29
Enrollment: 320
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will comprise male and non-pregnant female patients, aged 16-65years both inclusive, with morbid obesity.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: the remisson rate of NAFLD (for Base-NAFLD cohort)
timeFrame: 1 years after surgery
measure: Histological remission of NASH without worsening of fibrosis (for Base-NASH cohort)
timeFrame: 1 years after surgery
Secondary outcomes:
measure: the rate of fibrosis improvement without NASH worsening
timeFrame: 1 year after surgery
measure: changes in NASH and liver fbrosis biopsy fndings
timeFrame: 1 year after surgery
measure: changes in body weight
timeFrame: 3 months, 6 months, and 1 year after surgery
measure: resolution of obesity-related comorbidities
timeFrame: 1 year after surgery
measure: incidence of adverse health events
timeFrame: 1 year after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital
state: Beijing
Study officials:
affiliation: Beijing Friendship Hospital
name: Zhongtao Zhang, M.D.;Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wei L, Li M, Zeng N, Liu Y, Bai R, Zhang N, Song J, Zhang P, Yao Q, Yang Z, Zhao X, Zhang Y, Zhang P, Zhang Z. Bariatric surgery for non-alcoholic fatty liver disease in individuals with obesity (Base-NAFLD): protocol of a prospective multicenter observational follow-up study. BMC Surg. 2021 Jun 24;21(1):298. doi: 10.1186/s12893-021-01296-y.