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Completed

NCT Number: NCT03566173

Association Between Nonalcoholic Fatty Liver Disease and Acute Pancreatitis

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Ningbo NO.1 hospital

Ningbo, Zhejiang, 315010, China

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • diagnosed with AP
  • age >18 years

Exclusion criteria

  • an age of <18 years
  • without complete data and CT scans
  • previous splenectomy or hepatectomy
  • a past history of AP
  • an ambiguous pancreatic margin

Treatment and study plan

Primary outcomes

  1. Comparisons of variables (age in years, BMI in kg/m2, pancreas attenuation in HU) on the basis of AP severity

    Time frame: the physical examination data in the year of 2017

    Comparisons of variables on the basis of AP severity by one-way analysis of variance (ANOVA)

Secondary outcomes

  1. Association between NAFLD and severity outcomes in AP patients

    Time frame: the physical examination data in the year of 2017

    Association between liver/spleen attenuation (L/S) ratio in Hounsfield units (HU) and severity outcomes in AP patients by Cox regression analysis

Sponsors and collaborators

Lead sponsor

Ningbo No. 1 Hospital

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 25, 2018
Registry last updated
May 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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