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Body Parameters as an Independent Predictor of Acute Pancreatitis

Sponsor
Ningbo No. 1 Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03482921
Collaborator
(none)
1,662
Enrollment
1
Location
3.6
Actual Duration (Months)
455.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is to assess the predictive significance of visceral adipose tissue (VAT) and visceral adipose tissue /skeletal muscle tissue ratio (VAT/SMT ratio) for the prognosis in acute pancreatitis (AP) patients.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Acute pancreatitis (AP) is a sudden inflammation of the pancreas. However, one-fifth of patients may develop severe complications with a mortality between 10%-20% It remains a difficulty to find an effective method for prediction of severity of AP at early stage.

    It is well-established that obesity (defined as body mass index[BMI]>30kg/m2 by the World Health Organization) is a risk factor for AP and increases the incidence of systemic complication, motality. There are a lot of parameters related to saropenic obesity, including areas of visceral adipose tissue (VAT), subcutaneous adipose tissue (SAT), skeletal muscle tissue (SMT), and VAT/SMT ratio. it is unclear which parameter is the best predictor of severe AP. Thus, this study is aimed to investigate the association between these parameters and AP severity and find the best predictor of AP.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    1662 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    Body Parameters as an Independent Predictor of Acute Pancreatitis: A Propensity Score-matched Case-control Study
    Actual Study Start Date :
    Dec 1, 2017
    Actual Primary Completion Date :
    Feb 12, 2018
    Actual Study Completion Date :
    Mar 22, 2018

    Outcome Measures

    Primary Outcome Measures

    1. Comparisons of variables according to AP severity [the physical examination data in the year of 2017]

      Comparisons of variables according to AP severity by one-way analysis of variance (ANOVA) and Likelihood Ratio

    2. Relationships between VAT and severity outcomes Relationships between VAT and severity outcomes Relationships between VAT and severity outcomes Relationships between body parameters and severity outcomes [the physical examination data in the year of 2017]

      Relationships between VAT and severity outcomes by Likelihood Ratio

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    1. diagnosed with AP

    2. age >18 years

    Exclusion Criteria:

    1. age<18years

    2. missing data in the electronic medical record

    3. history of AP

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ningbo NO.1 hospital Ningbo Zhejiang China 315010

    Sponsors and Collaborators

    • Ningbo No. 1 Hospital

    Investigators

    • Principal Investigator: Lei Xu, Dr, Department of gastroenterology, Ningbo No.1 Hospital, Ningbo, China

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ningbo No. 1 Hospital
    ClinicalTrials.gov Identifier:
    NCT03482921
    Other Study ID Numbers:
    • Ningbo4
    First Posted:
    Mar 29, 2018
    Last Update Posted:
    Mar 29, 2018
    Last Verified:
    Mar 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Pancreatitis

    Study Results

    No Results Posted as of Mar 29, 2018