Multicenter Prospective Cohort Study of Hypertriglyceridemia Acute Pancreatitis

NCT ID: NCT06976099

Last Updated: 2025-05-16

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-11-13
• Study Completion Date: 2029-09-01

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.

Conditions

Acute Pancreatitis (AP); Hypertriglyceridemia Acute Pancreatitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

wen li, MD

Director, Biomarker Discovery and Validation Platform, Translational Medicine National Major Science and Technology Infrastructure at PUMCH

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

Affiliated Hangzhou First People's Hospital

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

K5714

Identifier Type: -

Identifier Source: org_study_id