Deep Biliary CannulationNCT01002404
The Use of Guide Wire in Biliary Cannulation: Angled or Straight Tipped Guide Wire?
A study testing angled and straight tipped guide wire in people with Deep Biliary Cannulation, run by Turku University Hospital at 1 site in Finland.
Trial summary
The purpose of the study is to prospectively evaluate the deep biliary cannulation in ERCP with the angled tipped guide wire or the straight tipped guide wire. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Deep Biliary Cannulation
- What is being tested?
- angled and straight tipped guide wire
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteFinland
- Study dates
- Oct 2009to Oct 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- the need for ERCP assessed by a specialist in gastrointestinal surgery
Who cannot join
- prior sphincterotomy
- age under 18
- age over 90
- contrast media allergy
- inability to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to prospectively evaluate the deep biliary cannulation in ERCP with the angled tipped guide wire or the straight tipped guide wire.
Read the detailed description
Patients coming to ERCP examination are being divided randomly to two different groups. The deep biliary cannulation is started with predetermined guide wire. If the cannulation does not succeed in two minutes, the procedure is continued as normal.
- Conditions
- Deep Biliary Cannulation
- Being tested
- angled and straight tipped guide wire
- Keywords
- ERCP, deep biliary cannulation, guide wire cannulation, post-ERCP pancreatitis, Success of deep biliary cannulation, Rate of post-ERCP pancreatitis, Time used to deep biliary cannulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
angled and straight tipped guide wireProcedure or surgery
Angled or straight tipped guide wire is used in the beginning of deep biliary cannulation in ERCP . If there is no success, other normal procedures (e.g. double wire cannulation and precut) are performed.
| Study group | Role | What they receive |
|---|---|---|
| angled tipped guide wire | Active comparator | angled tipped guide wire used to deep biliary cannulation Receives: Procedure: angled and straight tipped guide wire |
| straight tipped guidewire | Active comparator | straight guide wire used to deep biliary cannulation Receives: Procedure: angled and straight tipped guide wire |
What is being measured
The primary outcome is the main question the study is designed to answer.
The success rate of deep biliary cannulation
Measured: October 2010
Secondary outcomes (2)
Frequency of post-ERCP pancreatitis
Measured: October 2010
time spent to deep biliary cannulation
Measured: October 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Biliary CannulationStudies 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
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hanna Vihervaara, Turku University Hospital
- Investigators
- Hanna R Vihervaara, Principal investigator, Turku University HospitalJuha Grönroos, PhD, Study director, Turku University HospitalPaulina Salminen, PhD, Study director, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01002404
- Sponsor's protocol ID
- 23/180/2009
- 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
- The Use of Guide Wire in Biliary Cannulation: Angled or Straight Tipped Guide Wire?
- ClinicalTrials.gov ID
- NCT01002404
- Acronym / sponsor ID
- 23/180/2009
- Conditions
- Deep Biliary Cannulation
- Keywords
- ERCP, deep biliary cannulation, guide wire cannulation, post-ERCP pancreatitis, Success of deep biliary cannulation, Rate of post-ERCP pancreatitis, Time used to deep biliary cannulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- Oct 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 27 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.
The purpose of the study is to prospectively evaluate the deep biliary cannulation in ERCP with the angled tipped guide wire or the straight tipped guide wire.
Detailed description
Patients coming to ERCP examination are being divided randomly to two different groups. The deep biliary cannulation is started with predetermined guide wire. If the cannulation does not succeed in two minutes, the procedure is continued as normal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| angled tipped guide wire | Active comparator | Procedure: angled and straight tipped guide wireangled tipped guide wire used to deep biliary cannulation |
| straight tipped guidewire | Active comparator | Procedure: angled and straight tipped guide wirestraight guide wire used to deep biliary cannulation |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- the need for ERCP assessed by a specialist in gastrointestinal surgery
Key exclusion criteria (5 listed)
- prior sphincterotomy
- age under 18
- age over 90
- contrast media allergy
- inability to give informed consent
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 |
|---|---|---|
| angled and straight tipped guide wireAngled or straight tipped guide wire is used in the beginning of deep biliary cannulation in ERCP . If there is no success, other normal procedures (e.g. double wire cannulation and precut) are performed. | Procedure or surgery | angled tipped guide wire, straight tipped guidewire |
Primary outcome
The success rate of deep biliary cannulation
Time frame: October 2010
2 secondary outcomes
Frequency of post-ERCP pancreatitis
Time frame: October 2010
time spent to deep biliary cannulation
Time frame: October 2010
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 12 Oct 2011.
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.
Hanna R Vihervaara principal investigator
Turku University Hospital
Juha Grönroos, PhD study director
Turku University Hospital
Paulina Salminen, PhD study director
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 angled and straight tipped guide wire in people with Deep Biliary Cannulation, 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 1 inclusion and 5 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 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 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?
The success rate of deep biliary cannulation (time frame: October 2010). 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.