PancreatitisPhase 4NCT00786929
Acute Pancreatitis and Acute Fluid Collections
A Phase 4 study testing Catheter drainage and Conservative treatment in people with Pancreatitis, run by University Medical Center, Tuzla at 1 site in Bosnia and Herzegovina.
Trial summary
The purpose of this study is to evaluate if percutaneous drainage of sterile fluid collections recurring after initial aspiration in acute pancreatitis yielded better results than their conservative management. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pancreatitis
- What is being tested?
- Catheter drainage and Conservative treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteBosnia and Herzegovina
- Study dates
- Mar 2003to Dec 2007
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Symptoms and signs of acute pancreatitis and if pancreatic or/and peripancreatic fluid collections were confirmed by ultrasound and computed tomography examination
Who cannot join
- Collections resulting from pancreatic surgery, chronic pancreatitis and encapsulated collections and collections with uncertainty about the relationship between the collections and clinical symptoms and signs of acute pancreatitis were excluded.
Trial locations and contacts
1 site in 1 country.
Bosnia and Herzegovina1 site
University Clinical Center
Tuzla, TK, 75000
About this study
Official title: Randomized Controlled Trial on Sterile Fluid Collections Management in Acute Pancreatitis
The purpose of this study is to evaluate if percutaneous drainage of sterile fluid collections recurring after initial aspiration in acute pancreatitis yielded better results than their conservative management.
- Conditions
- Pancreatitis
- Being tested
- Catheter drainage, Conservative treatment
- Keywords
- Conversion to more aggressive treatment of recurrent fluid collection
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter drainageProcedure or surgery
Conservative treatmentDrug
| Study group | Role | What they receive |
|---|---|---|
| drainage | Experimental | Not described Receives: Procedure: Catheter drainage |
| 2 | Active comparator | Conservative treatment Receives: Drug: Conservative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conversion to more aggressive procedure
Measured: Sep 2007
Secondary outcomes (1)
Number of patients turning culture positive, length of hospital stay, catheter dwell time, catheter problems and changes per patient
Measured: Oct 2007
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2008 (estimated)
- Study startMar 2003
- Primary completionFeb 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center, Tuzla
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00786929
- Sponsor's protocol ID
- MB-68/02
- Status last verified
- Nov 2008
- First submitted
- 5 Nov 2008
- Last updated
- 4 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Bradley EL 3rd. A clinically based classification system for acute pancreatitis. Ann Chir. 1993;47(6):537-41. No abstract available.
PubMed 8105746
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial on Sterile Fluid Collections Management in Acute Pancreatitis
- ClinicalTrials.gov ID
- NCT00786929
- Acronym / sponsor ID
- MB-68/02
- Conditions
- Pancreatitis
- Keywords
- Conversion to more aggressive treatment of recurrent fluid collection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University Medical Center, TuzlaUniversity, hospital or other
- Study start
- Mar 2003
- Primary completion
- Feb 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 6 Nov 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 purpose of this study is to evaluate if percutaneous drainage of sterile fluid collections recurring after initial aspiration in acute pancreatitis yielded better results than their conservative management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| drainage | Experimental | Procedure: Catheter drainage |
| 2 | Active comparator | Drug: Conservative treatmentConservative treatment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Symptoms and signs of acute pancreatitis and if pancreatic or/and peripancreatic fluid collections were confirmed by ultrasound and computed tomography examination
Key exclusion criteria (1 listed)
- Collections resulting from pancreatic surgery, chronic pancreatitis and encapsulated collections and collections with uncertainty about the relationship between the collections and clinical symptoms and signs of acute pancreatitis were excluded.
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 |
|---|---|---|
| Catheter drainage | Procedure or surgery | drainage |
| Conservative treatment | Drug | 2 |
Primary outcome
Conversion to more aggressive procedure
Time frame: Sep 2007
1 secondary outcome
Number of patients turning culture positive, length of hospital stay, catheter dwell time, catheter problems and changes per patient
Time frame: Oct 2007
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 4 Feb 2009.
- Background: PubMed 8105746Bradley EL 3rd. A clinically based classification system for acute pancreatitis. Ann Chir. 1993;47(6):537-41. No abstract available.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Catheter drainage and Conservative treatment in people with Pancreatitis, run by University Medical Center, Tuzla at 1 site in Bosnia and Herzegovina.
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 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 4 Feb 2009. 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 Bosnia and Herzegovina. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Conversion to more aggressive procedure (time frame: Sep 2007). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00786929, which also lists 1 linked publication.
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 4 Feb 2009.