- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03601325
Acute Pancreatitis: Study of Possible Etiologies and Risk Factors Affecting Outcome
August 7, 2023 updated by: SMMostafa, Assiut University
Acute Pancreatitis: Study of Possible Etiologies and Risk Factors Affecting Outcome (Hospital Based Study)
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Assiut, Egypt, 71515
- Ahmed Mohammed Abu-Elfatth
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
All patients admitted in assuit university hospital during the period of the study and diagnosed as acute pancreatitis
Description
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 .
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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,..)
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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",
|
1 year
|
Hospital duration of stay
Time Frame: 1 year
|
Effect of each risk factor on hospital duration of stay
|
1 year
|
Rate of transfer to ICU
Time Frame: 1 year
|
Effect of each risk factor on rate of transfer to ICU
|
1 year
|
Mortality
Time Frame: 1 year
|
Effect of each risk factor on mortality
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Ashraf Osman, MD, Assiut University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2018
Primary Completion (Actual)
October 1, 2022
Study Completion (Actual)
October 30, 2022
Study Registration Dates
First Submitted
May 21, 2018
First Submitted That Met QC Criteria
July 24, 2018
First Posted (Actual)
July 26, 2018
Study Record Updates
Last Update Posted (Actual)
August 9, 2023
Last Update Submitted That Met QC Criteria
August 7, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Acute pancreatitis
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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