Effectiveness of Bariatric Surgery for NAFLD/NASH

Effectiveness of Bariatric Surgery for Nonalcoholic Fatty Liver Diseases/Nonalcoholic Steatohepatitis With Fibrosis : A Prospective, Multicentric Cohort Study

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 Overview

• Status: Recruiting
• Conditions: NAFLD; Bariatric Surgery Candidate; NASH With Fibrosis
• Intervention / Treatment: Procedure: SG; Procedure: RYGB; Procedure: OAGB

• Study Type: Observational
• Enrollment (Estimated): 320

Contacts and Locations

• Study Contact: Name: Zhongtao Zhang, M.D.;Ph.D.; Phone Number: +86-13801060364; Email: zhangzht@ccmu.edu.cn
• Study Contact Backup: Name: Mengyi Li, M.D.;Ph.D.; Phone Number: +86-15810993198; Email: limengyi@ccmu.edu.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100050
      • Recruiting
      • Beijing Friendship Hospital
      • Contact: Zhongtao Zhang, M.D.;Ph.D.; Phone Number: +86-13801060364; Email: zhangzht@ccmu.edu.cn
      • Principal Investigator: Zhongtao Zhang, M.D.;Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SG; In this group, the bariatric procedure is sleeve gastrectomy (SG), all operations follow the same standard operating procedure.	Procedure: SG; 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; In this group, the bariatric procedure is Roux-en-Y gastric bypass (RYGB), all operations follow the same standard operating procedure.	Procedure: RYGB; RYGB entails the creation of a 15-30 mL (approximate) gastric pouch, a 150 cm Roux limb, and a 50 cm biliopancreatic limb.
OAGB; In this group, the bariatric procedure is one anastomosis gastric bypass(OAGB), all operations follow the same standard operating procedure.	Procedure: OAGB; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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.	1 years after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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]) .	1 year after surgery
changes in body weight	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); percentage of total weight loss (%TWL): %TWL=([initial weight] - [postoperative weight])/([initial weight])×100	3 months, 6 months, and 1 year after surgery
resolution of obesity-related comorbidities	4．blood glucose levels, lipid levels, and liver enzyme levels.	1 year after surgery
incidence of adverse health events	Including but not limited to bleeding, ulcer, intestinal obstruction etc.	1 year after surgery

Collaborators and Investigators

• Sponsor: Beijing Friendship Hospital
• Collaborators: Beijing Tiantan Hospital; Beijing Chao Yang Hospital; The First Hospital of Hebei Medical University; Beijing Luhe Hospital, Capital Medical University; Beijing Hospital (only for Base-NAFLD); Beijing Shijitan Hospital, Capital Medical University Beijing Hospital (only for Base-NAFLD); Shanghai Jiao Tong University affiliated Sixth People's Hospital Beijing Hospital (only for Base-NAFLD); Huashan Hospital, Fudan University Beijing Hospital (only for Base-NAFLD); The First Hospital of Kunming; Bishan Hospital of Chongqiang Medical University
• Investigators: Principal Investigator: Zhongtao Zhang, M.D.;Ph.D., Beijing Friendship Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2020
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: April 21, 2020
• First Submitted That Met QC Criteria: April 26, 2020
• First Posted (Actual): April 29, 2020

Study Record Updates

• Last Update Posted (Actual): May 14, 2024
• Last Update Submitted That Met QC Criteria: May 10, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Fibrosis; Obesity; Bariatric surgery; NAFLD; NASH
• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis
• Other Study ID Numbers: Base-NAFLD/NASH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No