Effectiveness of Bariatric Surgery for NAFLD/NASH
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16-65
SponsorBeijing Friendship Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Age between 16 and 65 years (all sexes).
Disqualifiers
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.;
Trial population
The study population will comprise male and non-pregnant female patients, aged 16-65years both inclusive, with morbid obesity.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
SG
Procedure/SurgerySG involved a vertical gastric resection beginning 4-6 cm from the pylorus and ending 1-2 cm from the His angle, using linear staplers with the guidance of a 36 French intragastric bougie.
RYGB
Procedure/SurgeryRYGB entails the creation of a 15-30 mL (approximate) gastric pouch, a 150 cm Roux limb, and a 50 cm biliopancreatic limb.
OAGB
Procedure/SurgeryOAGB entails the creation of a long gastric tube by beginning 2 cm below the angular incisure starting from the lesser curvature side and then divided vertically upward by linear cutting staplers as calibrated with a 36 French bougie, followed by the creation of a single gastrojejunal anastomosis with an afferent biliopancreatic limb of 200 cm.
Treatment groups
320 Participants
are divided into 3 treatment groupsGroup A: SG1 intervention
Group B: RYGB1 intervention
Group C: OAGB1 intervention
Trial outcomes
Primary outcomes
1
the remisson rate of NAFLD (for Base-NAFLD cohort)
Percentage of liver fat content \<5% of abdominal magnetic resonance imaging(MRI) at 1 year after surgery. Visit : Post-op 12 months (±30 Days)
Time frame
1 years after surgery2
Histological remission of NASH without worsening of fibrosis (for Base-NASH cohort)
\*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.
Time frame
1 years after surgerySecondary outcomes
1
the rate of fibrosis improvement without NASH worsening
NASH worsening, was defined as an increase of ≥1 point in either the lobular inflammation score or the hepatocyte ballooning score.
Time frame
1 year after surgery2
changes in NASH and liver fbrosis biopsy fndings
2．including the NAS (NAFLD activity score) and SAF scores (steatosis \[S\], activity \[A\], and fbrosis \[F\]) .
Time frame
1 year after surgery3
changes in body weight
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
Time frame
3 months, 6 months, and 1 year after surgery4
resolution of obesity-related comorbidities
4．blood glucose levels, lipid levels, and liver enzyme levels.
Time frame
1 year after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Beijing Friendship Hospital
Lead sponsor
Beijing Tiantan Hospital
Collaborator
Beijing Hospital (only for Base-NAFLD)
Collaborator
Beijing Shijitan Hospital, Capital Medical University
Collaborator
Shanghai Jiao Tong University affiliated Sixth People's Hospital Beijing Hospital (only for Base-NAFLD)
Collaborator
Huashan Hospital, Fudan University Beijing Hospital (only for Base-NAFLD)
Collaborator
Beijing Chao Yang Hospital
Collaborator
Capital Medical University
Collaborator
The First Hospital of Kunming
Collaborator
Bishan Hospital of Chongqiang Medical University
Collaborator
The First Hospital of Hebei Medical University
Collaborator
Source ClinicalTrials.gov