Bariatric surgery for non-alcoholic fatty liver disease in individuals with obesity (Base-NAFLD): protocol of a prospective multicenter observational follow-up study
Luyang Wei,
Mengyi Li,
Na Zeng,
Yang Liu,
Rixing Bai,
Nengwei Zhang,
Jinghai Song,
Pin Zhang,
Qiyuan Yao,
Zhenghan Yang,
Xinyan Zhao,
Yun Zhang,
Peng Zhang,
Zhongtao Zhang
Affiliations
Luyang Wei
Department of General Surgery, Beijing Friendship Hospital, Capital Medical University and National Clinical Research Center for Digestive Diseases
Mengyi Li
Department of General Surgery, Beijing Friendship Hospital, Capital Medical University and National Clinical Research Center for Digestive Diseases
Na Zeng
National Clinical Research Center for Digestive Diseases, Beijing Friendship Hospital, Capital Medical University
Yang Liu
Department of General Surgery, Beijing Friendship Hospital, Capital Medical University and National Clinical Research Center for Digestive Diseases
Rixing Bai
Department of General Surgery, Tiantan Hospital, Capital Medical University
Nengwei Zhang
Department of General Surgery, Beijing Shijitan Hospital, Capital Medical University/Peking University, Ninth Clinical Medical College
Jinghai Song
Department of General Surgery, Beijing Hospital, National Center of Gerontology
Pin Zhang
Department of Bariatric and Metabolic Surgery, Shanghai Jiao Tong University Affiliated Sixth People’s Hospital
Qiyuan Yao
Center for Obesity and Metabolic Surgery, Huashan Hospital, Fudan University
Zhenghan Yang
Department of Radiology, Beijing Friendship Hospital, Capital Medical University
Xinyan Zhao
Liver Research Cennter, Beijing Friendship Hospital, Capital Medical University
Yun Zhang
Department of Biobank, Beijing Friendship Hospital, Capital Medical University
Peng Zhang
Department of General Surgery, Beijing Friendship Hospital, Capital Medical University and National Clinical Research Center for Digestive Diseases
Zhongtao Zhang
Department of General Surgery, Beijing Friendship Hospital, Capital Medical University and National Clinical Research Center for Digestive Diseases
Abstract Background Bariatric 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. Methods This 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. Discussion This 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 ).
