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NCT Number: NCT04366999

Effectiveness of Bariatric Surgery for NAFLD/NASH

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.

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Key information

Age range

16 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Friendship Hospital

Beijing, Beijing Municipality, 100050, China

Location status: Recruiting

Location contact

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

CONTACT

[email protected]

+86-13801060364

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

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

[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

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.

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. the remisson rate of NAFLD (for Base-NAFLD cohort)

    Time frame: 1 years after surgery

    Percentage of liver fat content <5% of abdominal magnetic resonance imaging(MRI) at 1 year after surgery.

    Visit : Post-op 12 months (±30 Days)

  2. Histological remission of NASH without worsening of fibrosis (for Base-NASH cohort)

    Time frame: 1 years after surgery

    *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.

Secondary outcomes

  1. the rate of fibrosis improvement without NASH worsening

    Time frame: 1 year after surgery

    NASH worsening, was defined as an increase of ≥1 point in either the lobular inflammation score or the hepatocyte ballooning score.

  2. changes in NASH and liver fbrosis biopsy fndings

    Time frame: 1 year after surgery

    2.including the NAS (NAFLD activity score) and SAF scores (steatosis [S], activity [A], and fbrosis [F]) .

  3. changes in body weight

    Time frame: 3 months, 6 months, and 1 year after surgery

    • 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
  4. resolution of obesity-related comorbidities

    Time frame: 1 year after surgery

    4.blood glucose levels, lipid levels, and liver enzyme levels.

  5. incidence of adverse health events

    Time frame: 1 year after surgery

    Including but not limited to bleeding, ulcer, intestinal obstruction etc.

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

+86-15810993198

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

CONTACT

[email protected]

+86-13801060364

Sponsors and collaborators

Lead sponsor

Beijing Friendship Hospital

Other

Collaborators

  • Beijing Chao Yang Hospital
  • Beijing Hospital (only for Base-NAFLD)
  • Beijing Shijitan Hospital, Capital Medical University
  • Beijing Tiantan Hospital
  • Bishan Hospital of Chongqiang Medical University
  • Capital 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

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2026
First posted
Apr 29, 2020
Registry last updated
May 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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