Severe Acute PancreatitisPhase 1NCT01607996
Effect of Epidural Anesthesia on Pancreatic Perfusion and Clinical Outcome in Patients With Severe Acute Pancreatitis
A Phase 1 study testing Epidural anesthesia in people with Severe Acute Pancreatitis, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
The aim of the study is to evaluate the safety, the potential beneficial effect of epidural anesthesia on pancreatic perfusion and clinical outcome of patients with severe acute pancreatitis. Read more about this study
- Who is it for?
- Ages 16 to 90 years
- Conditions the study is for
- Severe Acute Pancreatitis
- What is being tested?
- Epidural anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2005to Nov 2011
- Phase
- Phase 1
- 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 16 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Acute pancreatitis with Ranson Criteria over 2, and/or CRP over 100, and or pancreatic necrosis on CT scan
Who cannot join
- Coagulation disorders
- Skin infection of the vertebral region
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Geneva
Geneva, Canton of Geneva, 1211
About this study
Official title: Phase 1 Study of Epidural Anesthesia on Pancreatic Perfusion and Clinical Outcome in Patients With Severe Acute Pancreatitis
The aim of the study is to evaluate the safety, the potential beneficial effect of epidural anesthesia on pancreatic perfusion and clinical outcome of patients with severe acute pancreatitis.
Read the detailed description
High mortality in severe acute pancreatitis (AP) is linked to necrosis of the gland. Animal studies showed that epidural anesthesia (EA) restores pancreatic microcirculation and decreases the severity of AP. The aim of the study is to evaluate the safety of EA, its effect on pancreatic perfusion and clinical outcome of patients with AP.
- Conditions
- Severe Acute Pancreatitis
- Being tested
- Epidural anesthesia, Patient controlled intravenous analgesia
- Keywords
- Epidural anesthesia, pancreatic perfusion, pancreatic necrosectomy
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural anesthesiaProcedure or surgery
Epidural will be performed using carbostesin (0.1%), fentanyl (2 microg/ml) administered continuously at a rate of 6 to 15 ml/hour
Patient controlled intravenous analgesiaDrug
Fentanyl 10 microg/ml at continuous flow of 10 to 20 microg/hour
| Study group | Role | What they receive |
|---|---|---|
| Patient controlled intravenous analgesia | Active comparator | Fentanyl (10 microg/ml) continuous intravenous infusion at a rate of 10 to 20 microg/h Receives: Drug: Patient controlled intravenous analgesia |
| Epidural anesthesia | Experimental | Carbostesin (0.1%) and Fentanyl (2 microg/ml) at a continuous flow of 6 to 15 ml/hour Receives: Procedure: Epidural anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with adverse events related to epidural anesthesia
Adverse events related to epidural anesthesia include hypotensive episodes or infection of the catheter
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 to 5 weeks
Pancreatic perfusion measured by computerized tomography
Measured: On day 0 and day 2 or 3 after hospital admission
Secondary outcomes (1)
Clinical outcome
Lenght of stay, admission to intensive care unit, need for surgery
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 to 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2012 (estimated)
- Study startJul 2005
- Primary completionAug 2010
- Study completionNov 2011
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 Severe Acute PancreatitisStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leo Buhler, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01607996
- Sponsor's protocol ID
- HUG 02-0555
- Status last verified
- May 2012
- First submitted
- 22 May 2012
- Last updated
- 30 May 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Demirag A, Pastor CM, Morel P, Jean-Christophe C, Sielenkamper AW, Guvener N, Mai G, Berney T, Frossard JL, Buhler LH. Epidural anaesthesia restores pancreatic microcirculation and decreases the severity of acute pancreatitis. World J Gastroenterol. 2006 Feb 14;12(6):915-20. doi: 10.3748/wjg.v12.i6.915.
PubMed 16521220
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Epidural Anesthesia on Pancreatic Perfusion and Clinical Outcome in Patients With Severe Acute Pancreatitis
- ClinicalTrials.gov ID
- NCT01607996
- Acronym / sponsor ID
- HUG 02-0555
- Conditions
- Severe Acute Pancreatitis
- Keywords
- Epidural anesthesia, pancreatic perfusion, pancreatic necrosectomy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- Jul 2005
- Primary completion
- Aug 2010 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 30 May 2012 (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 aim of the study is to evaluate the safety, the potential beneficial effect of epidural anesthesia on pancreatic perfusion and clinical outcome of patients with severe acute pancreatitis.
Detailed description
High mortality in severe acute pancreatitis (AP) is linked to necrosis of the gland. Animal studies showed that epidural anesthesia (EA) restores pancreatic microcirculation and decreases the severity of AP. The aim of the study is to evaluate the safety of EA, its effect on pancreatic perfusion and clinical outcome of patients with AP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient controlled intravenous analgesia | Active comparator | Drug: Patient controlled intravenous analgesiaFentanyl (10 microg/ml) continuous intravenous infusion at a rate of 10 to 20 microg/h |
| Epidural anesthesia | Experimental | Procedure: Epidural anesthesiaCarbostesin (0.1%) and Fentanyl (2 microg/ml) at a continuous flow of 6 to 15 ml/hour |
Who may qualify
- Ages
- 16 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Acute pancreatitis with Ranson Criteria over 2, and/or CRP over 100, and or pancreatic necrosis on CT scan
Key exclusion criteria (2 listed)
- Coagulation disorders
- Skin infection of the vertebral region
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 |
|---|---|---|
| Epidural anesthesiaEpidural will be performed using carbostesin (0.1%), fentanyl (2 microg/ml) administered continuously at a rate of 6 to 15 ml/hour | Procedure or surgery | Epidural anesthesia |
| Patient controlled intravenous analgesiaFentanyl 10 microg/ml at continuous flow of 10 to 20 microg/hour | Drug | Patient controlled intravenous analgesia |
Primary outcome
Number of patients with adverse events related to epidural anesthesia
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 to 5 weeks
Adverse events related to epidural anesthesia include hypotensive episodes or infection of the catheter
Pancreatic perfusion measured by computerized tomography
Time frame: On day 0 and day 2 or 3 after hospital admission
1 secondary outcome
Clinical outcome
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 to 5 weeks
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 30 May 2012.
- Background: PubMed 16521220Demirag A, Pastor CM, Morel P, Jean-Christophe C, Sielenkamper AW, Guvener N, Mai G, Berney T, Frossard JL, Buhler LH. Epidural anaesthesia restores pancreatic microcirculation and decreases the severity of acute pancreatitis. World J Gastroenterol. 2006 Feb 14;12(6):915-20. doi: 10.3748/wjg.v12.i6.915.
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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 1 study testing Epidural anesthesia in people with Severe Acute Pancreatitis, run by University Hospital, Geneva at 1 site in Switzerland.
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 2 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 30 May 2012. 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 Switzerland. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Number of patients with adverse events related to epidural anesthesia (time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 to 5 weeks). The study lists 2 primary outcomes in all. 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 NCT01607996, 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 30 May 2012.