Efficacy and safety of intensive triglyceride-lowering therapy on reducing recurrence of hypertriglyceridemia-associated pancreatitis (REDUCE): protocol for a multicentre, randomised controlled trial
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Tao Chen,
Weiqin Li,
Chunping Zhu,
Na Liu,
Xin Xu,
Lihui Deng,
Dong Wu,
Yao Wu,
Jianhua Wan,
Xin Huang,
Lu Ke,
Wenhua He,
Hongwei Zhang,
Duan Wang,
Nong-Hua Lu,
Yin Zhu,
Ling Ding,
Jianing Li,
Jianwen Sheng,
Nonghua Lu,
Huifang Xiong,
Liang Xia,
Gaifang Liu,
Jinyi Sheng,
Lingyu Luo,
Yupeng Lei,
Huajing Ke,
Lanting Wang,
Shihang Zhang,
Zhihua Tang,
Youshun Liu,
Guan Gui,
Yingjie Chen,
Yinyu Pan
Affiliations
Tao Chen
Department of Clinical Sciences, Tropical Clinical Trials Unit, Liverpool School of Tropical Medicine, Liverpool, UK
Weiqin Li
Chunping Zhu
Department of Gastroenterology, Ganzhou People’s Hospital, Ganzhou, China
Na Liu
Binzhou Medical University, Yantai, Shandong, China
Xin Xu
Department of Gastroenterology, Jiangxi Provincial Key Laboratory of Digestive Diseases, Jiangxi Clinical Research Centre for Gastroenterology, Digestive Disease Hospital, The First Affiliated Hospital, Jiangxi Medical College, Nanchang University, Nanchang, Jiangxi, China
Lihui Deng
Department of Integrated Traditional Chinese and Western Medicine, West China Centre of Excellence for Pancreatitis, Institute of Integrated Traditional Chinese and Western Medicine, West China-Liverpool Biomedical Research Centre, West China Hospital, Sichuan University, Chengdu, China
Dong Wu
Department of Gastroenterology, Peking Union Medical College Hospital, Beijing, China
Yao Wu
Jianhua Wan
Xin Huang
Lu Ke
Department of Critical Care Medicine, Center of Severe Acute Pancreatitis (CSAP), Nanjing Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China
Wenhua He
Department of Gastroenterology, Jiangxi Provincial Key Laboratory of Digestive Diseases, Jiangxi Clinical Research Centre for Gastroenterology, Digestive Disease Hospital, The First Affiliated Hospital, Jiangxi Medical College, Nanchang University, Nanchang, Jiangxi, China
Hongwei Zhang
Department of Critical Care Medicine, JinJiang Hospital of Traditional Chinese Medicine, Jinjiang, China
Duan Wang
Nong-Hua Lu
Department of Gastroenterology, Jiangxi Provincial Key Laboratory of Digestive Diseases, Jiangxi Clinical Research Centre for Gastroenterology, Digestive Disease Hospital, The First Affiliated Hospital, Jiangxi Medical College, Nanchang University, Nanchang, Jiangxi, China
Yin Zhu
Department of Gastroenterology, Jiangxi Provincial Key Laboratory of Digestive Diseases, Jiangxi Clinical Research Centre for Gastroenterology, Digestive Disease Hospital, The First Affiliated Hospital, Jiangxi Medical College, Nanchang University, Nanchang, Jiangxi, China
Ling Ding
Department of Gastroenterology, Jiangxi Provincial Key Laboratory of Digestive Diseases, Jiangxi Clinical Research Centre for Gastroenterology, Digestive Disease Hospital, The First Affiliated Hospital, Jiangxi Medical College, Nanchang University, Nanchang, Jiangxi, China
Jianing Li
Jianwen Sheng
Department of Gastroenterology, Yichun people’s hospital, Yichun, China
Nonghua Lu
Huifang Xiong
Department of Gastroenterology, Jiangxi Provincial Key Laboratory of Digestive Diseases, Jiangxi Clinical Research Centre for Gastroenterology, Digestive Disease Hospital, The First Affiliated Hospital, Jiangxi Medical College, Nanchang University, Nanchang, Jiangxi, China
Liang Xia
Department of Gastroenterology, Jiangxi Provincial Key Laboratory of Digestive Diseases, Jiangxi Clinical Research Centre for Gastroenterology, Digestive Disease Hospital, The First Affiliated Hospital, Jiangxi Medical College, Nanchang University, Nanchang, Jiangxi, China
Gaifang Liu
Department of Gastroenterology, Hebei General Hospital, Shijiazhuang, China
Jinyi Sheng
Department of Gastroenterology, Jingdezhen First People’s Hospital, Jingdezhen, China
Lingyu Luo
Department of Gastroenterology, Jiangxi Provincial Key Laboratory of Digestive Diseases, Jiangxi Clinical Research Centre for Gastroenterology, Digestive Disease Hospital, The First Affiliated Hospital, Jiangxi Medical College, Nanchang University, Nanchang, Jiangxi, China
Introduction Recurrence of hypertriglyceridaemia-associated acute pancreatitis (HTG-AP) is common. Uncontrolled HTG after hospital discharge is an important risk factor for recurrence. However, the optimal triglyceride (TG) goal of lipid-lowering therapy for outpatients remains unclear. The efficacy and safety of intensive TG-lowering therapy on reducing recurrence of HTG-AP trial aims to determine whether intensive TG-lowering therapy (with a TG goal of <150 mg/dL (equal to 1.7 mmol/L)), compared with usual care (with a TG goal of <500 mg/dL (equal to 5.65 mmol/L)), can reduce recurrence in patients after a first episode of HTG-AP.Methods and analysis This is an investigator-initiated, multicentre, open-label, parallel, superiority, randomised, controlled trial. Adult patients who have been successfully treated and discharged from their index episode of HTG-AP will be screened for eligibility after a 4-week to 3-month run-in period in the outpatient setting, and then patients with the fasting serum TG levels ≥150 mg/dL at baseline are eligible. During the study period, a total of 256 study participants will be randomised to receive either intensive TG-lowering therapy or usual care. In the intensive TG-lowering therapy group, the goal of TG levels is lower than 150 mg/dL, which will be monitored at 1 month, 3 months, 6 months, 12 months and 18 months after randomisation. In the usual care group, the goal of TG levels is lower than 500 mg/dL according to the current guidelines. Lifestyle suggestions and TG-lowering agents are the main strategies to manage the lipid level. The primary endpoint is the incidence of recurrent episodes of HTG-AP at 18 months after randomisation.Ethics and dissemination This study has been approved by the Ethics Committee of the First Affiliated Hospital of Nanchang University (No. 2023101–3). Ethics approval of each participating centre is required before initiation of enrolment. The results of this study will be published in peer-reviewed journals and reported at international conferences.Trial registration number ChiCTR2300073483 (Chinese Clinical Trial Registry)Protocol version V.4.0 (2024).
