Acute PancreatitisNCT00699933
Diagnostic and Interventional Therapy in Acute Pancreatitis
An observational study of Acute Pancreatitis, run by University of Regensburg at 1 site in Germany.
Trial summary
The study aims to evaluate the course of patients with acute pancreatitis. Thereby we analyze different diagnostics and compare ultrasound, MRI and CT-scan in detection of necrotic areas and evaluate interventional therapy methods like percutaneous drainage techniques regarding the outcome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pancreatitis
- What is being tested?
- CT-guided percutaneous drainage technique
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- May 2008to Dec 2012
- 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: 50 patients with acute pancreatitis
Who may be able to join
- Age > 18 years
- Acute pancreatitis
- Written formal consent
Who cannot join
- Pregnancy
- Missing formal consent
- Individual contraindications for CT-scan
- MRI or endoscopic ultrasound
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Internal medicine I, University of Regensburg
Regensburg, 93053
Tanja Bruennler, Dr. med., +43-941-944 ext. 7010, tanja.bruennler@klinik.uni-r.de
Tanja Bruennler, Dr. med.
About this study
The study aims to evaluate the course of patients with acute pancreatitis. Thereby we analyze different diagnostics and compare ultrasound, MRI and CT-scan in detection of necrotic areas and evaluate interventional therapy methods like percutaneous drainage techniques regarding the outcome. Laboratory values were assessed as well.
Read the detailed description
For laboratory values different inflammation markers were measured and compared.
- Conditions
- Acute Pancreatitis
- Being tested
- CT-guided percutaneous drainage technique
- Keywords
- acute pancreatitis, interventional therapy, CT-guided drainage therapy, percutaneous necrosectomy, Comparison of different diagnostic procedures: MRI, CT, Ultrasound, Evaluation of interventional therapy including percutaneous drainage techniques und necrosectomies
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-guided percutaneous drainage techniqueOther
Evaluation of different diagnostics and evaluation of outcome of patients who received percutaneous CT-guided drainage for necrotic debridement and analyze the further outcome
| Study group | Role | What they receive |
|---|---|---|
| 1 | Evaluation of one study cohort Receives: Other: CT-guided percutaneous drainage technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
Measured: weekly
Secondary outcomes (3)
time to surgery
Measured: weekly
active necrosectomy
Measured: weekly
ICU stay
Measured: weekly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2008 (estimated)
- Study startMay 2008
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (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.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Regensburg
- Sponsor type
- University, hospital or other
- Investigators
- Jürgen Schölmerich, Prof., Study director, Director of Department of Internal Medicine IStefan Feuerbach, Prof., Study director, Director of Department of Radiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00699933
- Sponsor's protocol ID
- 08/008
- Status last verified
- Jun 2010
- First submitted
- 13 Jun 2008
- Last updated
- 9 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic and Interventional Therapy in Acute Pancreatitis
- ClinicalTrials.gov ID
- NCT00699933
- Acronym / sponsor ID
- 08/008
- Conditions
- Acute Pancreatitis
- Keywords
- acute pancreatitis, interventional therapy, CT-guided drainage therapy, percutaneous necrosectomy, Comparison of different diagnostic procedures: MRI, CT, Ultrasound, Evaluation of interventional therapy including percutaneous drainage techniques und necrosectomies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of RegensburgUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 18 Jun 2008 (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.
The study aims to evaluate the course of patients with acute pancreatitis. Thereby we analyze different diagnostics and compare ultrasound, MRI and CT-scan in detection of necrotic areas and evaluate interventional therapy methods like percutaneous drainage techniques regarding the outcome. Laboratory values were assessed as well.
Detailed description
For laboratory values different inflammation markers were measured and compared.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: CT-guided percutaneous drainage techniqueEvaluation of one study cohort |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 50 patients with acute pancreatitis
Key inclusion criteria (3 listed)
- Age > 18 years
- Acute pancreatitis
- Written formal consent
Key exclusion criteria (4 listed)
- Pregnancy
- Missing formal consent
- Individual contraindications for CT-scan
- MRI or endoscopic ultrasound
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT-guided percutaneous drainage techniqueEvaluation of different diagnostics and evaluation of outcome of patients who received percutaneous CT-guided drainage for necrotic debridement and analyze the further outcome | Other | 1 |
Primary outcome
Length of hospital stay
Time frame: weekly
3 secondary outcomes
time to surgery
Time frame: weekly
active necrosectomy
Time frame: weekly
ICU stay
Time frame: weekly
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2011.
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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.
Jürgen Schölmerich, Prof. study director
Director of Department of Internal Medicine I
Stefan Feuerbach, Prof. study director
Director of Department of Radiology
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 Acute Pancreatitis, run by University of Regensburg at 1 site in Germany.
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 3 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 9 Aug 2011. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tanja Bruennler, Dr. med. (+49-941-944 ext. 7010, tanja.bruennler@klinik.uni-r.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay (time frame: weekly). 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 2011.