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OpenTrials
Completed

NCT Number: NCT03394378

The Impact of Non-Alcoholic Fatty Pancreas Disease on Outcome of Acute Pancreatitis

Obesity is a well-established risk factor for acute pancreatitis (AP). As for non-alcoholic fatty pancreas disease (NAFPD), it is evident that it is correlated with obesity. This is apparently the first study evaluating the association between NAFPD and severity of AP after taking into account several covariates.

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Key information

Age range

18 year–100 year

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 common disease with a highly variable clinical course, which can range from a mild, self-limited disease to severe disease with a mortality rate of 10-20%. It is vital to distinguish severe cases early because they require more aggressive fluid resuscitation and early nutritional support.

Obesity is a well-established risk factor for acute pancreatitis (AP). It leads to ectopic fat accumulation in visceral organs, such as the liver, skeletal muscles, heart and pancreas.

Assuming that attenuation in the pancreas seen on unenhanced computed tomography (CT) scanning is inversely associated with severe outcomes in AP, we investigated the relationship between NAFPD and severity of AP and the significance of pancreas attenuation for the prognosis and mortality in AP patients. The result of this study suggest that decreased pancreas attenuation and P/S ratio are strong predictors of severe pancreatitis, mortality, systemic complication.

Who can participate

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

Inclusion criteria

  • diagnosed with AP
  • age>18y

Exclusion criteria

  • age<18y
  • missing data in the electronic medical record
  • prior attacks of AP
  • without spleen
  • with ambiguous pancreatic margin

Treatment and study plan

Primary outcomes

  1. Comparison of characteristics and variables according to severity of AP.

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

    Comparison of characteristics and variables according to severity of AP by One-Way Analysis of variance(ANOVA) and Pearson chi-square test.

  2. The association between pancreas attenuation and ICU transfer, pancreatitis severity, systemic and local complications and prognostic scores (APACHE II scores, Ranson score, BISAP score and SIRS).

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

    The association between pancreas attenuation and ICU transfer, pancreatitis severity, systemic and local complications and prognostic scores (APACHE II scores, Ranson score, BISAP score and SIRS) by Likelihood Ratio test.

  3. BMI adjusted hazard ratios (HRs) and 95% CIs for the relationship between NAFPD and mortality of acute pancreatitis, evaluated by pancreas attenuation (HU), P/S ratio.

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

    BMI adjusted hazard ratios (HRs) and 95% CIs for the relationship between NAFPD and mortality of acute pancreatitis, evaluated by pancreas attenuation (HU), P/S ratio by cox proportional hazards models.

Sponsors and collaborators

Lead sponsor

Ningbo No. 1 Hospital

Other

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jan 9, 2018
Registry last updated
Jan 9, 2018

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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