Multicenter Prospective Cohort Study of Hypertriglyceridemia Acute Pancreatitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Acute Pancreatitis (AP), Hypertriglyceridemia Acute Pancreatitis. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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.
Primary outcome measures
- Incidence of organ dysfunction [Time frame: 1-2 weeks]
- Clinical outcomes [Time frame: 1-2 weeks]
- Incidence of recurrent HTG-AP [Time frame: 1 year]
- Risk factors for recurrence [Time frame: 1 year]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 12 centers
- Peking Union Medical College Hospital — Beijing
- Xuanwu Hospital, Capital Medical University — Beijing
- Nanfang Hospital, Southern Medical University — Guangzhou
- Affiliated Hospital of Zunyi Medical University — Zunyi
- First Affiliated Hospital of Harbin Medical University — Harbin
- Third Xiangya Hospital of Central South University — Changsha
- First Affiliated Hospital of Nanjing Medical University — Nanjing
- Affiliated Hospital of Yangzhou University — Yangzhou
- … and 4 more centers
Identifiers
NCT: NCT06976099 · K5714