Effectiveness of Bariatric Surgery for NAFLD/NASH

NCT04366999 | Recruiting

• 1 other identifier: Base-NAFLD/NASH
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 1

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.

Conditions

Bariatric Surgery Candidate; NAFLD; NASH With Fibrosis

Keywords

Bariatric surgery; NAFLD; NASH; Fibrosis; Obesity

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• the rate of fibrosis improvement without NASH worsening

  1 year after surgery

• changes in NASH and liver fbrosis biopsy fndings

  1 year after surgery

• changes in body weight

  3 months, 6 months, and 1 year after surgery

• resolution of obesity-related comorbidities

  1 year after surgery

• incidence of adverse health events

  1 year after surgery

Study Arms (3)

SG

In this group, the bariatric procedure is sleeve gastrectomy (SG), all operations follow the same standard operating procedure.

Procedure: SG

RYGB

In this group, the bariatric procedure is Roux-en-Y gastric bypass (RYGB), all operations follow the same standard operating procedure.

Procedure: RYGB

OAGB

In this group, the bariatric procedure is one anastomosis gastric bypass(OAGB), all operations follow the same standard operating procedure.

Procedure: OAGB

Interventions

SG PROCEDURE

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.

SG

RYGB PROCEDURE

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

RYGB

OAGB PROCEDURE

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.

OAGB

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \[For Base-NAFLD\]
• 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.
• \[For Base-NASH\]
• 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.
• Histologically confirmed NASH with fibrosis:
• NAFLD activity score(NAS) ≥4 with at least 1 in each single item and NASH-CRN fibrosis stage ≥F1

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Friendship Hospital: lead
• Beijing Tiantan Hospital: collaborator
• Beijing Hospital (only for Base-NAFLD): collaborator
• Beijing Shijitan Hospital, Capital Medical University Beijing Hospital (only for Base-NAFLD): 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

Study Sites (1)

Beijing Friendship Hospital

Beijing, Beijing Municipality, 100050, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 34167531 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Paired liver biopsy: Intraoperative, at least 1-year after surgery

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Fibrosis; Obesity

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms

Study Officials

• Zhongtao Zhang, M.D.;Ph.D.

  Beijing Friendship Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhongtao Zhang, M.D.;Ph.D.

CONTACT

+86-13801060364; zhangzht@ccmu.edu.cn

Mengyi Li, M.D.;Ph.D.

CONTACT

+86-15810993198; limengyi@ccmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of general surgery, principal investigator

Study Record Dates

• First Submitted: April 21, 2020
• First Posted: April 29, 2020
• Study Start: April 21, 2020
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 14, 2024

Record last verified: 2024-05

Locations

CN (1)