Acute PancreatitisNCT02223325
Evaluation of Prognosis and Prognostic Scores in Geriatric Patients With Acute Pancreatitis
An observational study of Acute Pancreatitis, run by Gazi University.
Trial summary
To compare the prognosis of acute pancreatitis between geriatric and other adult patients To evaluate the efficacy of various prognostic scores in geriatric patients with acute pancreatitis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pancreatitis
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Aug 2014to Aug 2016
- 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: Tertiary care patients
Who may be able to join
- Acute pancreatitis Hospitalisation Adult patients
Who cannot join
- Recurrent pancreatitis
- Chronic pancreatitis
- Outpatient follow up
- Loss of follow up within 3 months of discharge
About this study
Official title: Evaluation of Prognosis and Prognostic Scores in Geriatric Patients With Acute Pancreatitis: A Prospective Cohort Study
- To compare the prognosis of acute pancreatitis between geriatric and other adult patients
- To evaluate the efficacy of various prognostic scores in geriatric patients with acute pancreatitis
- Conditions
- Acute Pancreatitis
- Keywords
- Elderly, Prognosis
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Elderly, acute pancreatitis | No intervention | |
| Adults <65 y, acute pancreatitis | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality rate in geriatric patients with acute pancreatitis
Measured: Within 3 months
Secondary outcomes (1)
Morbidity rate in geriatric patients with acute pancreatitis
Measured: Within 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PancreatitisStudies of the same condition, open and under way.
- More trials run by Gazi 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-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibrahim Koral Onal, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02223325
- Sponsor's protocol ID
- YOnal - 001
- Status last verified
- Aug 2014
- First submitted
- 15 Aug 2014
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Prognosis and Prognostic Scores in Geriatric Patients With Acute Pancreatitis: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT02223325
- Acronym / sponsor ID
- YOnal - 001
- Conditions
- Acute Pancreatitis
- Keywords
- Elderly, Prognosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Aug 2016 (estimated)
- First posted
- 22 Aug 2014 (estimated)
- 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.
- To compare the prognosis of acute pancreatitis between geriatric and other adult patients
- To evaluate the efficacy of various prognostic scores in geriatric patients with acute pancreatitis
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elderly, acute pancreatitis | – | –No intervention |
| Adults <65 y, acute pancreatitis | – | –No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Tertiary care patients
Key inclusion criteria (1 listed)
- Acute pancreatitis Hospitalisation Adult patients
Key exclusion criteria (4 listed)
- Recurrent pancreatitis
- Chronic pancreatitis
- Outpatient follow up
- Loss of follow up within 3 months of discharge
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
Mortality rate in geriatric patients with acute pancreatitis
Time frame: Within 3 months
1 secondary outcome
Morbidity rate in geriatric patients with acute pancreatitis
Time frame: Within 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Pancreatitis, run by Gazi University.
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 20 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Mortality rate in geriatric patients with acute pancreatitis (time frame: Within 3 months). 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 20 Nov 2015.