Effectiveness of Bariatric Surgery for NAFLD/NASH

Bariatric Surgery Candidate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04366999
• Other study ID #: Base-NAFLD/NASH
• Status: Recruiting
• Start date: April 21, 2020
• Est. completion date: December 31, 2026

Study information

• Verified date: May 2024
• Source: Beijing Friendship Hospital
• Contact: Zhongtao Zhang, M.D.;Ph.D.
• Phone: +86-13801060364
• Email: zhangzht[@]ccmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Fibrosis
• NAFLD

Intervention

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
RYGB entails the creation of a 15-30 mL (approximate) gastric pouch, a 150 cm Roux limb, and a 50 cm biliopancreatic limb.
• 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.

Locations

Country	Name	City	State
China	Beijing Friendship Hospital	Beijing	Beijing

Sponsors (11)

Lead Sponsor

Collaborator

Beijing Friendship Hospital

Beijing Chao Yang Hospital, Beijing Hospital (only for Base-NAFLD), Beijing Luhe Hospital, Capital Medical University, Beijing Shijitan Hospital, Capital Medical University Beijing Hospital (only for Base-NAFLD), Beijing Tiantan Hospital, Bishan Hospital of Chongqiang Medical University, Huashan Hospital, Fudan University Beijing Hospital (only for Base-NAFLD), Shanghai Jiao Tong University affiliated Sixth People's Hospital Beijing Hospital (only for Base-NAFLD), The First Hospital of Hebei Medical University, The First Hospital of Kunming

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	resolution of obesity-related comorbidities	4.blood glucose levels, lipid levels, and liver enzyme levels.	1 year after surgery
Secondary	incidence of adverse health events	Including but not limited to bleeding, ulcer, intestinal obstruction etc.	1 year after surgery