Multicenter Prospective Cohort Study of Hypertriglyceridemia Acute Pancreatitis

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Invitation-only

Conditions: Hypertriglyceridemia Acute Pancreatitis; Acute Pancreatitis (AP)

Study type: Observational

Funder types: Other

Identifiers

NCT06976099

K5714

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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.