Multicenter Prospective Cohort Study of Hypertriglyceridemia Acute Pancreatitis

NCT06976099 | Enrolling By Invitation

• 1 other identifier: K5714
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 12

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

Outcome Measures

Primary Outcomes (4)

• Incidence of organ dysfunction

  Assessment of multi-organ dysfunction syndrome (MODS), acute respiratory distress syndrome (ARDS), acute kidney injury (AKI), and other complications

  1-2 weeks

• Clinical outcomes

  Hospital length of stay, ICU admission rate, and mortality

  1-2 weeks

• Incidence of recurrent HTG-AP

  The recurrence rate within a defined period

  1 year

• Risk factors for recurrence

  Identification of factors such as triglyceride (TG) levels, BMI, diabetes status, medication use, and lifestyle habits.

  1 year

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (12)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100010, China

Location

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100010, China

Location

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

Location

Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, 563003, China

Location

First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150001, China

Location

Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

Location

First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location

Affiliated Hospital of Yangzhou University

Yangzhou, Jiangsu, 225000, China

Location

First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, 116011, China

Location

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

Location

First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location

Affiliated Hangzhou First People's Hospital

Hangzhou, Zhejiang, 310006, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood: 1 purple-topped tube x 4mL (EDTA anticoagulant plasma separation tube) and 1 red-topped/yellow-topped tube x 4mL (serum separation tube) Fresh Urine: 10 mL

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Biomarker Discovery and Validation Platform, Translational Medicine National Major Science and Technology Infrastructure at PUMCH

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: May 16, 2025
• Study Start: November 13, 2024
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: May 16, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (12)