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

NCT03394378 | Completed

• 1 other identifier: Ningbo3
• Study Type: observational
• Target: 1,662
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Alcoholic Fatty Pancreas Disease; Acute Pancreatitis

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• diagnosed with AP
• age\>18y

You may not qualify if:

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

Sponsors & Collaborators

• Ningbo No. 1 Hospital: lead

Study Sites (1)

Ningbo NO.1 hospital

Ningbo, Zhejiang, 315010, China

Location

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Study Officials

• Lei Xu, Dr

  Department of gastroenterology,Ningbo No.1 Hospital, Ningbo, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2018
• First Posted: January 9, 2018
• Study Start: November 6, 2017
• Primary Completion: December 3, 2017
• Study Completion: December 15, 2017
• Last Updated: January 9, 2018

Record last verified: 2018-01

Locations

CN (1)