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 Type
OBSERVATIONAL
Enrollment
320
SG 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 entails the creation of a 15-30 mL (approximate) gastric pouch, a 150 cm Roux limb, and a 50 cm biliopancreatic limb.
OAGB 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.
Beijing Friendship Hospital
Beijing, Beijing Municipality, China
RECRUITINGthe 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 surgery
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 surgery
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 surgery
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 surgery
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 surgery
resolution of obesity-related comorbidities
4.blood glucose levels, lipid levels, and liver enzyme levels.
Time frame: 1 year after surgery
incidence of adverse health events
Including but not limited to bleeding, ulcer, intestinal obstruction etc.
Time frame: 1 year after surgery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.