Multicenter Prospective Cohort Study of Hypertriglyceridemia Acute Pancreatitis
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 1,000
- 试验地点
- 12
- 主要终点
- Incidence of organ dysfunction
研究概览
简要总结
Hypertriglyceridemia-associated acute pancreatitis (HTG-AP) is the second leading cause in China and is receiving increasing global attention. Research on HTG-AP has been hindered by the heterogeneity and complexity of the disease, as well as the limitations of prior single-center studies with small sample sizes, inadequate collection of clinical data, lack of sustainable follow-up, and insufficient tools for large-scale data collection, analysis, and biomarker testing. To address these unique challenges and leverage the opportunity to gain a deeper understanding of HTG-AP, the China Hypertriglyceridemia Pancreatitis Study Group (CHPSG) was initiated in April 2023 as a multi-center collaboration. By utilizing the advantages of multi-center studies, such as external validity and larger sample sizes, CHPSG aims to investigate the prevalence, clinical characteristics, natural history, and risk factors of HTG-AP in China. The consortium will also explore the differences between HTG-AP and other etiologies of pancreatitis, with an emphasis on systemic and local complications, recurrence, and long-term quality of life. Through its phased approach, CHPSG seeks to develop targeted strategies for the prevention and treatment of HTG-AP, ultimately improving patient outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 18 and 80 years;
- •Diagnosed with AP based on at least two of the following criteria (1) acute onset of upper abdominal pain; (2) more than three times the upper limit of the normal range of serum lipase or amylase levels; and (3) typical radiological findings of AP on computed tomography (CT), magnetic resonance imaging, or ultrasonography;
- •HTG with serum triglyceride levels >500 mg/dL (5.65 mmol/L) during the current AP episode or at admission;
- •Patients must have good compliance, with the ability and willingness to adhere to study protocols, provide written informed consent, and maintain their current lifestyle during the study period
排除标准
- •History of chronic pancreatitis or pancreatic cancer;
- •Severe comorbidities such as malignancy, acute myocardial infarction, or extensive cerebral infarction;
- •Prior use of lipid-lowering medications;
- •Pregnancy or breastfeeding;
- •Lack of signed informed consent.
结局指标
主要结局
Incidence of organ dysfunction
时间窗: 1-2 weeks
Assessment of multi-organ dysfunction syndrome (MODS), acute respiratory distress syndrome (ARDS), acute kidney injury (AKI), and other complications
Clinical outcomes
时间窗: 1-2 weeks
Hospital length of stay, ICU admission rate, and mortality
Incidence of recurrent HTG-AP
时间窗: 1 year
The recurrence rate within a defined period
Risk factors for recurrence
时间窗: 1 year
Identification of factors such as triglyceride (TG) levels, BMI, diabetes status, medication use, and lifestyle habits.
次要结局
未报告次要终点
研究者
wen li, MD
Director, Biomarker Discovery and Validation Platform, Translational Medicine National Major Science and Technology Infrastructure at PUMCH
Peking Union Medical College Hospital