Multicenter Prospective Cohort Study of Hypertriglyceridemia Acute Pancreatitis

• Conditions: Acute Pancreatitis (AP); Hypertriglyceridemia Acute Pancreatitis

• Registration Number: NCT06976099
• Lead Sponsor: Peking Union Medical College Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-11-13
• Status Verified: 2025-03
• Study First Submitted: 2025-03-10
• Study First Submitted QC: 2025-05-08
• Last Update Submitted: 2025-05-08
• Study First Posted: 2025-05-16
• Last Update Posted: 2025-05-16
• Primary Completion: 2029-09-01
• Study Completion: 2029-09-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of organ dysfunction	1-2 weeks	Assessment of multi-organ dysfunction syndrome (MODS), acute respiratory distress syndrome (ARDS), acute kidney injury (AKI), and other complications
Clinical outcomes	1-2 weeks	Hospital length of stay, ICU admission rate, and mortality
Incidence of recurrent HTG-AP	1 year	The recurrence rate within a defined period
Risk factors for recurrence	1 year	Identification of factors such as triglyceride (TG) levels, BMI, diabetes status, medication use, and lifestyle habits.

Trial Locations

Locations (12)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China

Xuanwu Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, 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

First Affiliated Hospital of Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China

Affiliated Hangzhou First People's Hospital; 🇨🇳 Hangzhou, Zhejiang, China