PancreatitisNCT03601325
Acute Pancreatitis: Study of Possible Etiologies and Risk Factors Affecting Outcome
An observational study of Pancreatitis, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatitis
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2018to 30 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients admitted in assuit university hospital during the period of the study and diagnosed as acute pancreatitis
Who may be able to join
- -
- 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
Who cannot join
- No exclusion criteria .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Pancreatitis
- Keywords
- pancreatitis
- Medical subject headings
- Pancreatitis
What is being measured
The primary outcome is the main question the study is designed to answer.
The frequency of different etiologies of AP in our locality
At the end of study, total number of patients of each etiology of acute pancreatitis will be calculated as (Gallstones, Alcohol, triglyceridemia, Idiopathic, ERCP,..)
Measured: 1 year
Secondary outcomes (4)
Outcome of the patients according to the Atlanta Classification 2012 revision
Effect of each risk factor on outcome as progression to mild, moderate severe and severe pancreatitis "according to the Atlanta Classification 2012 revision",
Measured: 1 year
Hospital duration of stay
Effect of each risk factor on hospital duration of stay
Measured: 1 year
Rate of transfer to ICU
Effect of each risk factor on rate of transfer to ICU
Measured: 1 year
Mortality
Effect of each risk factor on mortality
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start1 Oct 2018
- Primary completion1 Oct 2022
- Study completion30 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PancreatitisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SMMostafa, Assiut University
- Investigators
- Ashraf Osman, MD, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03601325
- Sponsor's protocol ID
- Acute pancreatitis
- Status last verified
- Aug 2023
- First submitted
- 21 May 2018
- Last updated
- 9 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Pancreatitis: Study of Possible Etiologies and Risk Factors Affecting Outcome (Hospital Based Study)
- ClinicalTrials.gov ID
- NCT03601325
- Acronym / sponsor ID
- Acute pancreatitis
- Conditions
- Pancreatitis
- Keywords
- pancreatitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 26 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admitted in assuit university hospital during the period of the study and diagnosed as acute pancreatitis
Key inclusion criteria (5 listed)
- -
- 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
Key exclusion criteria (1 listed)
- No exclusion criteria .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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,..)
4 secondary outcomes
Outcome of the patients according to the Atlanta Classification 2012 revision
Time frame: 1 year
Hospital duration of stay
Time frame: 1 year
Rate of transfer to ICU
Time frame: 1 year
Mortality
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashraf Osman, MD study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatitis, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The frequency of different etiologies of AP in our locality (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2023.