Biliary ObstructionNCT00990366
Treatment of Biliary Obstruction Using Biliary Stent With or Without Antireflux Valve
A study testing Cook´s biliary stent with an antireflux stent, normal biliary stent in people with Biliary Obstruction and Cholangitis, run by Turku University Hospital at 1 site in Finland.
Trial summary
Biliary obstruction can be relieved by biliary stent. Ascending infection of biliary passage (cholangitis) causes hospitalization and obstruction of stents. Reflux of intestinal fluids through a stent is thought to be one of the causes of cholangitis. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Biliary Obstruction, Cholangitis
- What is being tested?
- Cook´s biliary stent with an antireflux stent, normal biliary stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFinland
- Study dates
- Oct 2009to Nov 2010
- Phase
- Interventional
- 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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18-89
- biliary obstruction in the lower two thirds of the choledochus
Who cannot join
- allergy to contrast media
- future pancreaticoduodenectomy
- refusal from the study
- previous stent
Trial locations and contacts
1 site in 1 country.
About this study
Biliary obstruction can be relieved by biliary stent. Ascending infection of biliary passage (cholangitis) causes hospitalization and obstruction of stents. Reflux of intestinal fluids through a stent is thought to be one of the causes of cholangitis. Stents with antireflux valves are designed to reduce the reflux from the bowel. The purpose of the study is to investigate prospectively whether it is possible to reduce the amount of infection and thus obstruction of biliary stent by using a stent with an antireflux valve compared to a normal stent without an antireflux valve.
- Conditions
- Biliary Obstruction, Cholangitis
- Being tested
- Cook´s biliary stent with an antireflux stent, normal biliary stent
- Keywords
- antireflux valve, biliary obstruction, cholangitis, biliary stent
- Medical subject headings
- Cholangitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cook´s biliary stent with an antireflux stent, normal biliary stentDevice
arms are assigned randomly by closed envelope method
| Study group | Role | What they receive |
|---|---|---|
| biliary stent without an antireflux valve | Active comparator | patients with biliary obstruction who need a biliary stent, selected for the stent without an antireflux valve arm Receives: Device: Cook´s biliary stent with an antireflux stent, normal biliary stent |
| biliary stent with an antireflux valve | Active comparator | patients with biliary obstruction, who need a biliary stent, selected for the stent with an antireflux valve arm Receives: Device: Cook´s biliary stent with an antireflux stent, normal biliary stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
patency of a biliary stent
Measured: one year
Secondary outcomes (1)
Cholangitis
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionNov 2010
- Study completionNov 2010
Why it stopped: Interim analysis results, study terminated 5/2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary ObstructionStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hanna Vihervaara, Turku University Hospital
- Investigators
- Paulina Salminen, MD, Principal investigator, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00990366
- Sponsor's protocol ID
- 58/180/2009
- Status last verified
- Oct 2011
- First submitted
- 5 Oct 2009
- Last updated
- 12 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Biliary Obstruction Using Biliary Stent With or Without Antireflux Valve
- ClinicalTrials.gov ID
- NCT00990366
- Acronym / sponsor ID
- 58/180/2009
- Conditions
- Biliary Obstruction, Cholangitis
- Keywords
- antireflux valve, biliary obstruction, cholangitis, biliary stent
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim analysis results, study terminated 5/2010
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- Oct 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 6 Oct 2009 (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.
Biliary obstruction can be relieved by biliary stent. Ascending infection of biliary passage (cholangitis) causes hospitalization and obstruction of stents. Reflux of intestinal fluids through a stent is thought to be one of the causes of cholangitis. Stents with antireflux valves are designed to reduce the reflux from the bowel. The purpose of the study is to investigate prospectively whether it is possible to reduce the amount of infection and thus obstruction of biliary stent by using a stent with an antireflux valve compared to a normal stent without an antireflux valve.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| biliary stent without an antireflux valve | Active comparator | Device: Cook´s biliary stent with an antireflux stent, normal biliary stentpatients with biliary obstruction who need a biliary stent, selected for the stent without an antireflux valve arm |
| biliary stent with an antireflux valve | Active comparator | Device: Cook´s biliary stent with an antireflux stent, normal biliary stentpatients with biliary obstruction, who need a biliary stent, selected for the stent with an antireflux valve arm |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age 18-89
- biliary obstruction in the lower two thirds of the choledochus
Key exclusion criteria (4 listed)
- allergy to contrast media
- future pancreaticoduodenectomy
- refusal from the study
- previous stent
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 |
|---|---|---|
| Cook´s biliary stent with an antireflux stent, normal biliary stentarms are assigned randomly by closed envelope method | Device | biliary stent with an antireflux valve, biliary stent without an antireflux valve |
Primary outcome
patency of a biliary stent
Time frame: one year
1 secondary outcome
Cholangitis
Time frame: one year
Results and safety
The study was stopped early (reason given: Interim analysis results, study terminated 5/2010). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 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.
Paulina Salminen, MD principal investigator
Turku University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cook´s biliary stent with an antireflux stent, normal biliary stent in people with Biliary Obstruction and Cholangitis, run by Turku University Hospital 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 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: stopped early, as of the sponsor's last update on 12 Oct 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 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 was stopped early (reason given: Interim analysis results, study terminated 5/2010). 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?
patency of a biliary stent (time frame: one year). 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 12 Oct 2011.