Association Between Nonalcoholic Fatty Liver Disease and Acute Pancreatitis

Acute Pancreatitis Clinical Trial

Official title:

Association Between Nonalcoholic Fatty Liver Disease and Acute Pancreatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03566173
• Other study ID #: Ningbo5
• Status: Completed
• Start date: March 10, 2018
• Est. completion date: April 15, 2018

Study information

• Verified date: April 2019
• Source: Ningbo No. 1 Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The early evaluation of AP severity are vital. Previous studies have shown non-alcoholic fatty liver disease (NAFLD) is associated with severity of acute pancreatitis (AP). This study is aimed to investigate the relationship between NAFLD and AP severity.

Description:

Acute pancreatitis (AP) is a potentially lethal disease capable of wide clinical variation. Severe acute pancreatitis (SAP) is devastating, with a mortality rate ranging from 10% to as high as 85%. So it's important to identify severe patients which require aggressive early treatment and prolonged specialist care. There are a lot of multifactorial scorings and specific laboratory tests in predicting AP severity, such as Ranson's, Acute Physiology and Chronic Health Examination (APACHE)-II, serum Interleukin-6 (IL-6), and C-reactive protein (CRP) level. However, they have limitations in predicting outcomes of AP patients. The biochemical markers are not accurate enough. Ranson's scores were calculated after 48 hours of admission. Their practical utilization as predictors of severity is tough. Novel prognostic biomarker is needed to further develop for prognosis in AP patients.

Nonalcoholic fatty liver disease (NAFLD) refers to fat deposition and oxidative stress of free radicals in hepatocytes. NAFLD is the most common chronic liver disease worldwide. The prevalence averages 30% in developed countries, and estimated to be 10% in developing countries. Its presentation ranges from asymptomatic steatosis to fibrosis, and cirrhosis with 3-5%. It is evident clinically with increased risk of developing obesity, cardiovascular diseases (CVD), hyperlipidaemia, and type 2 diabetes mellitus (T2DM). Acting as an endocrine organ, the liver is the source of adipokines and inflammatory cytokines. Alterations in the production and secretion are increased in patients with NAFLD. It is strongly related to insulin resistance (IR) and metabolic disorders. Previous studies noted that NAFLD is closely related to severity of AP. CT scans are usually performed at admission to diagnose AP severity, which are also helpful to assess NAFLD. It could act as a valuable prognostic factor in AP patients and help to recognize potential severe patients.

However, no clear pathways could explain the association between NAFLD and AP at present. Besides, the data is scarce. More research will pay more attention to this topic. In this study, the investigators investigated the association between NAFLD and AP.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1662
• Est. completion date: April 15, 2018
• Est. primary completion date: April 1, 2018
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. diagnosed with AP

2. age >18 years

Exclusion Criteria:

1. an age of <18 years

2. without complete data and CT scans

3. previous splenectomy or hepatectomy

4. a past history of AP

5. an ambiguous pancreatic margin

Related Conditions & MeSH terms

• Acute Pancreatitis
• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease
• Nonalcoholic Fatty Liver Disease
• Pancreatitis

Locations

Country	Name	City	State
China	Ningbo NO.1 hospital	Ningbo	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Ningbo No. 1 Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparisons of variables (age in years, BMI in kg/m2, pancreas attenuation in HU) on the basis of AP severity	Comparisons of variables on the basis of AP severity by one-way analysis of variance (ANOVA)	the physical examination data in the year of 2017
Secondary	Association between NAFLD and severity outcomes in AP patients	Association between liver/spleen attenuation (L/S) ratio in Hounsfield units (HU) and severity outcomes in AP patients by Cox regression analysis	the physical examination data in the year of 2017