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Acute Pancreatitis: Study of Possible Etiologies and Risk Factors Affecting Outcome

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ClinicalTrials.gov Identifier: NCT03601325
Recruitment Status : Unknown
Verified July 2018 by SMMostafa, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : July 26, 2018
Last Update Posted : July 26, 2018
Sponsor:
Information provided by (Responsible Party):
SMMostafa, Assiut University

Tracking Information
First Submitted Date May 21, 2018
First Posted Date July 26, 2018
Last Update Posted Date July 26, 2018
Estimated Study Start Date October 1, 2018
Estimated Primary Completion Date October 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 24, 2018)
The frequency of different etiologies of AP in our locality [ Time Frame: 1 year ]
At the end of study, total number of patients of each etiology of acute pancreatitis will be calculated as (Gallstones, Alcohol, triglyceridemia, Idiopathic, ERCP,..)
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: July 24, 2018)
  • Outcome of the patients according to the Atlanta Classification 2012 revision [ Time Frame: 1 year ]
    Effect of each risk factor on outcome as progression to mild, moderate severe and severe pancreatitis "according to the Atlanta Classification 2012 revision",
  • Hospital duration of stay [ Time Frame: 1 year ]
    Effect of each risk factor on hospital duration of stay
  • Rate of transfer to ICU [ Time Frame: 1 year ]
    Effect of each risk factor on rate of transfer to ICU
  • Mortality [ Time Frame: 1 year ]
    Effect of each risk factor on mortality
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Acute Pancreatitis: Study of Possible Etiologies and Risk Factors Affecting Outcome
Official Title Acute Pancreatitis: Study of Possible Etiologies and Risk Factors Affecting Outcome (Hospital Based Study)
Brief Summary This study is to assess the frequency of different etiologies of acute pancreatitis in our locality & assess the effect of different risk factors on outcome of the patients.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population All patients admitted in assuit university hospital during the period of the study and diagnosed as acute pancreatitis
Condition Pancreatitis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: July 24, 2018)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 30, 2020
Estimated Primary Completion Date October 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

-

Diagnosis of acute pancreatitis according to the following: the presence of two of the three following criteria:

  • abdominal pain consistent with the disease
  • serum amylase and or lipase greater than three times the upper limit of normal
  • characteristic findings from abdominal imaging Contrast-enhanced computed tomographic (CECT) and or magnetic resonance imaging (MRI) of the pancreas

Exclusion Criteria:

  • No exclusion criteria .
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03601325
Other Study ID Numbers Acute pancreatitis
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party SMMostafa, Assiut University
Study Sponsor Assiut University
Collaborators Not Provided
Investigators
Study Director: Ashraf Osman, MD Assiut University
PRS Account Assiut University
Verification Date July 2018