Multicenter Prospective Cohort Study of Hypertriglyceridemia Acute Pancreatitis

N/AEnrolling By InvitationNCT06976099

Peking Union Medical College Hospital1,000 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,000

Conditions

Acute Pancreatitis (AP)Hypertriglyceridemia Acute Pancreatitis

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (12)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, China

First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Third Xiangya Hospital of Central South University

Changsha, Hunan, China

First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Affiliated Hospital of Yangzhou University

Yangzhou, Jiangsu, China

First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

...and 2 more locations

Outcomes

Primary Outcomes

Incidence of organ dysfunction

Assessment of multi-organ dysfunction syndrome (MODS), acute respiratory distress syndrome (ARDS), acute kidney injury (AKI), and other complications

Time frame: 1-2 weeks

Clinical outcomes

Hospital length of stay, ICU admission rate, and mortality

Time frame: 1-2 weeks

Incidence of recurrent HTG-AP

The recurrence rate within a defined period

Time frame: 1 year

Risk factors for recurrence

Identification of factors such as triglyceride (TG) levels, BMI, diabetes status, medication use, and lifestyle habits.

Time frame: 1 year