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Body Parameters as an Independent Predictor of Acute Pancreatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03482921
Recruitment Status : Completed
First Posted : March 29, 2018
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
Ningbo No. 1 Hospital

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
Acute Pancreatitis

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 1662 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 7 Years
Official Title: Body Parameters as an Independent Predictor of Acute Pancreatitis: A Propensity Score-matched Case-control Study
Actual Study Start Date : December 1, 2017
Actual Primary Completion Date : February 12, 2018
Actual Study Completion Date : March 22, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis




Primary Outcome Measures :
  1. Comparisons of variables according to AP severity [ Time Frame: 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 [ Time Frame: the physical examination data in the year of 2017 ]
    Relationships between VAT and severity outcomes by Likelihood Ratio



Information from the National Library of Medicine

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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 was defined as 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 the normal level, and (3) characteristic findings of AP on a CT scanning.
Criteria

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

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): NCT03482921


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
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ningbo No. 1 Hospital
ClinicalTrials.gov Identifier: NCT03482921    
Other Study ID Numbers: Ningbo4
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pancreatitis
Pancreatic Diseases
Digestive System Diseases