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

Completed

• Conditions: Acute Pancreatitis; Non-Alcoholic Fatty Pancreas Disease

• Registration Number: NCT03394378
• Lead Sponsor: Ningbo No. 1 Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2017-11-06
• Primary Completion: 2017-12-03
• Study Completion: 2017-12-15
• Status Verified: 2018-01
• Study First Submitted: 2018-01-03
• Study First Submitted QC: 2018-01-03
• Last Update Submitted: 2018-01-03
• Study First Posted: 2018-01-09
• Last Update Posted: 2018-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1662

Inclusion Criteria

1. diagnosed with AP
2. age>18y

Exclusion Criteria

1. age<18y
2. missing data in the electronic medical record
3. prior attacks of AP
4. without spleen
5. with ambiguous pancreatic margin

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of characteristics and variables according to severity of AP.	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.
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).	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.
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.	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.

Trial Locations

Locations (1)

Ningbo NO.1 hospital; 🇨🇳 Ningbo, Zhejiang, China