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

Acute Pancreatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03394378
• Other study ID #: Ningbo3
• Status: Completed
• Phase: N/A
• First received: January 3, 2018
• Last updated: January 3, 2018
• Start date: November 6, 2017
• Est. completion date: December 15, 2017

Study information

• Verified date: January 2018
• Source: Ningbo No. 1 Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1662
• Est. completion date: December 15, 2017
• Est. primary completion date: December 3, 2017
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pancreatitis
• Non-Alcoholic Fatty Pancreas Disease
• Pancreatic Diseases
• 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	Comparison of characteristics and variables according to severity of AP.	Comparison of characteristics and variables according to severity of AP by One-Way Analysis of variance(ANOVA) and Pearson chi-square test.	the physical examination data in the year of 2017
Primary	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 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.	the physical examination data in the year of 2017
Primary	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.	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.	the physical examination data in the year of 2017