Clinical trial NCT03394378: The Impact of Non-Alcoholic Fatty Pancreas Disease on Outcome of Acute Pancreatitis
Official title: The Impact of Non-Alcoholic Fatty Pancreas Disease on Outcome of Acute Pancreatitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Alcoholic Fatty Pancreas Disease
Acute Pancreatitis
Lead sponsor: Ningbo No. 1 Hospital
Sponsor class: OTHER
First posted: 2018-01-09
Enrollment: 1662
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diagnosis criteria for AP were the presence of at least 2 of the 3 following factors: (1) abdominal pain characteristic of AP, (2) serum amylase and/or lipase levels\>= 3 times the upper limit of normal, and (3) characteristic findings of AP on a CT scan

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.

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of characteristics and variables according to severity of AP.
timeFrame: the physical examination data in the year of 2017
measure: 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).
timeFrame: the physical examination data in the year of 2017
measure: 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.
timeFrame: the physical examination data in the year of 2017
Secondary outcomes:
Other outcomes:
Locations:
city: Ningbo
country: China
facility: Ningbo NO.1 hospital
state: Zhejiang
Study officials:
affiliation: Department of gastroenterology,Ningbo No.1 Hospital, Ningbo, China
name: Lei Xu, Dr
role: PRINCIPAL_INVESTIGATOR
References: