Skip to content

Multicenter Prospective Cohort Study of Hypertriglyceridemia Acute Pancreatitis

Multicenter Prospective Cohort Study of Hypertriglyceridemia Acute Pancreatitis

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06976099
Enrollment
1000
Registered
2025-05-16
Start date
2024-11-13
Completion date
2029-09-01
Last updated
2025-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Pancreatitis (AP), Hypertriglyceridemia Acute Pancreatitis

Brief summary

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.

Interventions

None listed

Sponsors

Peking Union Medical College Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Incidence of organ dysfunction1-2 weeksAssessment of multi-organ dysfunction syndrome (MODS), acute respiratory distress syndrome (ARDS), acute kidney injury (AKI), and other complications
Clinical outcomes1-2 weeksHospital length of stay, ICU admission rate, and mortality
Incidence of recurrent HTG-AP1 yearThe recurrence rate within a defined period
Risk factors for recurrence1 yearIdentification of factors such as triglyceride (TG) levels, BMI, diabetes status, medication use, and lifestyle habits.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026