Recurrent Acute PancreatitisNCT00523874
Recurrence of Acute Alcoholic Pancreatitis
An observational study of Recurrent Acute Pancreatitis, run by Tampere University at 1 site in Finland.
Trial summary
Previously our retrospective study showed that almost half of the patients with acute alcoholic pancreatitis had a recurrent attack in the long-term, mild pancreatitis and young age being risk factors for recurrence. The aim of this prospective follow-up study was aimed to find out the risk factors in detail. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Acute Pancreatitis
- How many people
- 120 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2001to May 2007
- 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
Who may be able to join
- Patients who survived their first acute alcoholic pancreatitis. The diagnostic criteria for acute pancreatitis were epigastric pain, serum amylase > 3 x upper normal range, elevated serum CRP and signs of acute pancreatitis in imaging. Other etiologies were excluded.
- High alcohol consumption was detected
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Previously our retrospective study showed that almost half of the patients with acute alcoholic pancreatitis had a recurrent attack in the long-term, mild pancreatitis and young age being risk factors for recurrence. The aim of this prospective follow-up study was aimed to find out the risk factors in detail.
Read the detailed description
Patients admitted to Tampere University Hospital for first acute alcoholic pancreatitis were included. The diagnostic criteria for acute pancreatitis were epigastric pain, serum amylase > 3 x upper normal range, elevated serum CRP and signs of acute pancreatitis in imaging. Other etiologies were excluded. Alcohol consumption and dependency were detected. Serum and fecal markers of the endocrine and exocrine function and secretin stimulated MRCP were studied. The patients were followed median 38 (25 - 61) months for the recurrences and had a follow up visit at two years to investigate trends in the alcohol consumption.
- Conditions
- Recurrent Acute Pancreatitis
- Medical subject headings
- Pancreatitis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2007 (estimated)
- Study startJan 2001
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Acute PancreatitisStudies of the same condition, open and under way.
- 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
- Defined population
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University
- Sponsor type
- University, hospital or other
- Investigators
- Isto Nordback, MD,dos, Study director, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00523874
- Sponsor's protocol ID
- R00126
- Status last verified
- Jan 2001
- First submitted
- 31 Aug 2007
- Last updated
- 3 Sep 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recurrence of Acute Alcoholic Pancreatitis
- ClinicalTrials.gov ID
- NCT00523874
- Acronym / sponsor ID
- R00126
- Conditions
- Recurrent Acute Pancreatitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Tampere UniversityUniversity, hospital or other
- Study start
- Jan 2001
- Study completion
- May 2007 (actual)
- First posted
- 3 Sep 2007 (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.
Previously our retrospective study showed that almost half of the patients with acute alcoholic pancreatitis had a recurrent attack in the long-term, mild pancreatitis and young age being risk factors for recurrence. The aim of this prospective follow-up study was aimed to find out the risk factors in detail.
Detailed description
Patients admitted to Tampere University Hospital for first acute alcoholic pancreatitis were included. The diagnostic criteria for acute pancreatitis were epigastric pain, serum amylase > 3 x upper normal range, elevated serum CRP and signs of acute pancreatitis in imaging. Other etiologies were excluded. Alcohol consumption and dependency were detected. Serum and fecal markers of the endocrine and exocrine function and secretin stimulated MRCP were studied. The patients were followed median 38 (25 - 61) months for the recurrences and had a follow up visit at two years to investigate trends in the alcohol consumption.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who survived their first acute alcoholic pancreatitis. The diagnostic criteria for acute pancreatitis were epigastric pain, serum amylase > 3 x upper normal range, elevated serum CRP and signs of acute pancreatitis in imaging. Other etiologies were excluded.
- High alcohol consumption was detected
Key exclusion criteria (0 listed)
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
Not reported in the source record.
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 3 Sep 2007.
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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.
Isto Nordback, MD,dos study director
Tampere University Hospital
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 Recurrent Acute Pancreatitis, run by Tampere University at 1 site in Finland.
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 2 inclusion and 0 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 3 Sep 2007. 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 Finland. 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.
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 3 Sep 2007.