Multicenter Prospective Cohort Study of Hypertriglyceridemia Acute Pancreatitis

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.

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Key information

Conditions

Acute Pancreatitis (AP) Digestive System Diseases Hypertriglyceridemia Acute Pancreatitis Pancreatic Diseases Pancreatitis

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking Union Medical College Hospital, Beijing, Beijing Municipality, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Incidence of organ dysfunction

Time frame: 1-2 weeks

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

Time frame: 1-2 weeks

Hospital length of stay, ICU admission rate, and mortality
Incidence of recurrent HTG-AP

Time frame: 1 year

The recurrence rate within a defined period
Risk factors for recurrence

Time frame: 1 year

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

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Important dates

Study start: 2024
Primary completion: 2029
Study completion: 2029
First posted: May 16, 2025
Registry last updated: May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed