Acute pancreatitis
Conditions
Interventions
Intensive triglyceride-lowering therapy group:The intensive TG-lowering therapy strategy included the prescription of the TG-lowering agents after randomization to achieve the goal of controlling fast
Usual care group:The usual care strategy included the advices on maintaining current lifestyle during the study period without taking TG-lowering agents when fasting serum TG levels = 5.65 mmol/L. The
Sponsors
The First Affiliated Hospital of Nanchang University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients with index episode of HTG-AP, and HTG is the exclusive cause for AP (HTG-AP was diagnosed when patients had AP with serum TG > 1000 mg/dL or a serum TG level of 500-1000 mg/dL accompanied by chylous serum absent of other causes for AP); 2. Aged >= 18 years; 3. Time from discharge to randomisation >= 4 weeks (no more than 3 months, and the day of discharge will not be counted), and patients without AP onset-related symptoms between discharge and randomisation; 4. Fasting serum TG levels at baseline >= 150 mg/dL; 5. Expression of good compliance, and willingness to maintain current lifestyle during the study period.
Exclusion criteria
Exclusion criteria: 1. Usage of any medications that may affect serum TG levels four weeks before randomisation; 2. With active liver disease including primary biliary cirrhosis and persistent abnormal liver function of unknown cause, or active peptic ulcer; 3. Pregnant or lactating women, or women with a pregnancy plan within 18 months; 4. History of hypothyroidism, nephrotic syndrome, Cushing syndrome, or acquired immunodeficiency syndrome; 5. History of chronic pancreatitis or pancreatic cancer; 6. History of severe cardiovascular disease and organ dysfunction, such as malignancy, heart failure, coronary artery disease, chronic obstructive pulmonary disease, liver failure, or kidney failure; 7. No signed informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence rate of recurrent episodes of HTG-AP; | — |
Secondary
| Measure | Time frame |
|---|---|
| PAN-PROMISE score;Fasting serum TG level;Fasting serum cholesterol level;Fasting serum low-density lipoprotein cholesterol level;Fasting serum high-density lipoprotein cholesterol level;Fasting serum glucose level;Fasting serum glycated Hemoglobin level;Weight;Body mass index;Waist circumference;The status of smoking;The status of drinking;The incidence rate of stress hyperglycemia;The Incidence rate of post-acute pancreatitis diabetes mellitus;The incidence rate of abdominal obesity;The incidence rate of pancreatic exocrine insufficiency;The incidence rate of chronic pancreatitis;Quality of life assessed by assessments of the EuroQOL 5-dimensions (EQ-5D-5L);Unplanned readmission rate;All-cause mortality; | — |
Countries
China
Contacts
Public ContactZhu Yin
The First Affiliated Hospital of Nanchang University
Outcome results
None listed