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

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ClinicalTrials.gov Identifier: NCT03394378
Recruitment Status : Completed
First Posted : January 9, 2018
Last Update Posted : January 9, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Non-Alcoholic Fatty Pancreas Disease Acute Pancreatitis

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.

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Study Type : Observational
Actual Enrollment : 1662 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: The Impact of Non-Alcoholic Fatty Pancreas Disease on Outcome of Acute Pancreatitis
Actual Study Start Date : November 6, 2017
Actual Primary Completion Date : December 3, 2017
Actual Study Completion Date : December 15, 2017

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Primary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03394378


Locations
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China, Zhejiang
Ningbo NO.1 hospital
Ningbo, Zhejiang, China, 315010
Sponsors and Collaborators
Ningbo No. 1 Hospital
Investigators
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Principal Investigator: Lei Xu, Dr Department of gastroenterology,Ningbo No.1 Hospital, Ningbo, China
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Responsible Party: Ningbo No. 1 Hospital
ClinicalTrials.gov Identifier: NCT03394378    
Other Study ID Numbers: Ningbo3
First Posted: January 9, 2018    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018
Additional relevant MeSH terms:
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Pancreatitis
Pancreatic Diseases
Digestive System Diseases