Bariatric surgery for non-alcoholic fatty liver disease in individuals with obesity (Base-NAFLD): protocol of a prospective multicenter observational follow-up study

BMC Surgery

Qiyuan Yao¹  Pin Zhang²  Yun Zhang³  Zhongtao Zhang⁴  Luyang Wei⁴  Mengyi Li⁴  Peng Zhang⁴  Yang Liu⁴  Jinghai Song⁵  Nengwei Zhang⁶  Rixing Bai⁷  Zhenghan Yang⁸  Xinyan Zhao⁹  Na Zeng^1,10 

[1] Center for Obesity and Metabolic Surgery, Huashan Hospital, Fudan University, No. 12 Middle Wulumuqi Road, 200040, Shanghai, China;Department of Bariatric and Metabolic Surgery, Shanghai Jiao Tong University Affiliated Sixth People’s Hospital, No.600 Yishan Road, 200233, Shanghai, China;Department of Biobank, Beijing Friendship Hospital, Capital Medical University, No.95 Yong-an Road, Xi-Cheng, 100050, Beijing, China;Department of General Surgery, Beijing Friendship Hospital, Capital Medical University and National Clinical Research Center for Digestive Diseases, No. 95 Yong-an Road, Xi-Cheng, 100050, Beijing, China;Department of General Surgery, Beijing Hospital, National Center of Gerontology, No. 1 Dahua Road, Dong Dan, Dong-Cheng, 100730, Beijing, China;Department of General Surgery, Beijing Shijitan Hospital, Capital Medical University/Peking University, Ninth Clinical Medical College, Tieyilu 10, Yangfangdian, Haidian, 100038, Beijing, China;Department of General Surgery, Tiantan Hospital, Capital Medical University, No. 119, South West Ring Road, Fengtai, 100070, Beijing, China;Department of Radiology, Beijing Friendship Hospital, Capital Medical University, No.95 Yong-an Road, Xi-Cheng, 100050, Beijing, China;Liver Research Cennter, Beijing Friendship Hospital, Capital Medical University, No.95 Yong-an Road, Xi-Cheng, 100050, Beijing, China;National Clinical Research Center for Digestive Diseases, Beijing Friendship Hospital, Capital Medical University, 100050, Beijing, China;

关键词: Bariatric surgery;    Non-alcoholic fatty liver disease;    Metabolic associated fatty liver disease;    Sleeve gastrostomy;    Roux-en-Y gastric bypass;    One anastomosis gastric bypass;   

DOI  :  10.1186/s12893-021-01296-y

来源: Springer

【 摘 要 】

BackgroundBariatric surgery may be indicated in patients with nonalcoholic fatty liver disease (NAFLD) to achieve and maintain the degree of weight loss required to ensure therapeutic effects. However, bariatric surgery is still underrecognized in the treatment of NAFLD, including its inflammatory subtype, nonalcoholic steatohepatitis (NASH). Moreover, there is a lack of follow-up outcome data on different types of bariatric surgery in patients with NAFLD. This study aims to adequately assess the effect of bariatric surgery on NAFLD remission in obese patients.MethodsThis prospective multicentre observational follow-up study will include 142 obese patients with NAFLD scheduled to undergo one of the following surgical procedures: sleeve gastrostomy, Roux-en-Y gastric bypass, and one anastomosis gastric bypass. The primary outcome is the complete remission rate of NAFLD one year postoperatively, which is defined by liver fat fraction < 5% on magnetic resonance imaging; the secondary outcomes includes (i) changes in NASH and liver fibrosis biopsy findings, (ii) changes in body weight and abdominal adipose weight, (iii) resolution of obesity-related comorbidities, and (iv) incidence of adverse events. A long-term follow-up related to this study will also be conducted.DiscussionThis study will provide a necessary and preliminary foundation for the early identification and targeted treatment of patients with NAFLD who can be referred for bariatric surgery, as indicated for management of obesity and metabolic disease.Trial registration: Clinicaltrials.gov: NCT04366999. Registered 21 April 2020. (https://clinicaltrials.gov/ct2/show/NCT04366999).

【 授权许可】

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