Clinical trial NCT06976099: Multicenter Prospective Cohort Study of Hypertriglyceridemia Acute Pancreatitis
Official title: Multicenter Prospective Cohort Study of Hypertriglyceridemia Acute Pancreatitis
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Acute Pancreatitis (AP)
Hypertriglyceridemia Acute Pancreatitis
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2025-05-16
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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.


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.

Primary outcomes:
measure: Incidence of organ dysfunction
timeFrame: 1-2 weeks
measure: Clinical outcomes
timeFrame: 1-2 weeks
measure: Incidence of recurrent HTG-AP
timeFrame: 1 year
measure: Risk factors for recurrence
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
state: Beijing
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
state: Guangdong
city: Zunyi
country: China
facility: Affiliated Hospital of Zunyi Medical University
state: Guizhou
city: Harbin
country: China
facility: First Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Changsha
country: China
facility: Third Xiangya Hospital of Central South University
state: Hunan
city: Nanjing
country: China
facility: First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
city: Yangzhou
country: China
facility: Affiliated Hospital of Yangzhou University
state: Jiangsu
city: Dalian
country: China
facility: First Affiliated Hospital of Dalian Medical University
state: Liaoning
city: Xi'an
country: China
facility: First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
city: Hangzhou
country: China
facility: First Affiliated Hospital of Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: Affiliated Hangzhou First People's Hospital
state: Zhejiang
Study officials:
References: