Stenosis of Bile DuctNCT03638700
Comparison of Two High Performance Guidewires in ERCP
A study testing VisiGlide™ angled tip, VisiGlide2™ angled tip and VisiGlide™ straight tip in people with Stenosis of Bile Duct, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
Trial summary
In ERCP guidewires are used for the insertion of endoprostheses and the cannulation of stenosis. This leads to two essential requirements for the wire systems: The use of a (highly) flexible, hydrophilic wire to achieve successful and rapid passage of the narrow passage; for additional intervention, modern wires are… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stenosis of Bile Duct
- What is being tested?
- VisiGlide™ angled tip, VisiGlide2™ angled tip and VisiGlide™ straight tip
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 453 participants
- Where
- 1 siteGermany
- Study dates
- May 2016to Jan 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Obstruction of the biliary tract (cross sectional imaging or ultrasonography/lab data
Who cannot join
- Operatively alternated anatomy of the patient
Trial locations and contacts
1 site in 1 country.
Germany1 site
Goethe University Hospital Frankfurt
Frankfurt am Main, Hesse, 60590
About this study
Official title: Comparison of the Use of Two High Performance Guidewires in Patients With Stenosis of the Bile Ducts in ERCP: A Randomised Multicenter Trial
In ERCP guidewires are used for the insertion of endoprostheses and the cannulation of stenosis. This leads to two essential requirements for the wire systems: The use of a (highly) flexible, hydrophilic wire to achieve successful and rapid passage of the narrow passage; for additional intervention, modern wires are equipped with a stable shaft with which e.g. bougies, dilatation catheters, or stents can be introduced. Guidewires are available with angled or straight tips whose use differ regionally. Guidewires with angled tips are used predominantly in Japan, whereas in the Western world incl. Germany straight wires are commonly used. In a recently published study examining the intubation of the native papilla, successful intubation of the papilla was faster with guidewires with angled tips than with guidewires with straight tips. However, this did not result in an effect upon the time-independent rate of the successful papilla intubation.
The investigators test the hypothesis that 1) a higher success rate of the ERCP can be achieved with the use of an angled guidewire than with a straight guidewire and 2) a higher success rate of the ERCP can be achieved with the use of a type 1 guidewire than with a type 2 guidewire
Read the detailed description
This is a randomized, multicentric study.
- Conditions
- Stenosis of Bile Duct
- Being tested
- VisiGlide™ angled tip, VisiGlide2™ angled tip, VisiGlide™ straight tip, VisiGlide2™ straight tip
- Keywords
- stenosis, bile duct, guidewire, ercp
- Medical subject headings
- Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VisiGlide™ angled tipDevice
Arm A: Primary use of VisiGlide™ guidewire (angled tip). In case it should not be possible to complete one step toward the therapeutic goal after 8 to max. 12 minutes after start of the examination, the wire system is changed: primary change to VisiGlide™ (straight tip) resp. to VisiGlid2e™ (tip according to the examiner)
VisiGlide2™ angled tipDevice
Arm B: Primary use of VisiGlide2™ guidewire (angled tip). In case it should not be possible to complete one step toward the therapeutic goal after 8 to max. 12 minutes after start of the examination, the wire system is changed: primary change to VisiGlide2™ (straight tip) resp. to VisiGlide™ (tip according to the examiner)
VisiGlide™ straight tipDevice
Arm C: Primary use of VisiGlide™ guidewire (straight tip). In case it should not be possible to complete one step toward the therapeutic goal after 8 to max. 12 minutes after start of the examination, the wire system is changed: primary change to VisiGlide™ (angled tip) resp. to VisiGlide2™ (tip according to the examiner)
VisiGlide2™ straight tipDevice
Arm D: Primary use of VisiGlide2™ guidewire (straight tip). In case it should not be possible to complete one step toward the therapeutic goal after 8 to max. 12 minutes after start of the examination, the wire system is changed: primary change to VisiGlide2™ (angled tip) resp. to VisiGlide1™ (tip according to the examiner)
| Study group | Role | What they receive |
|---|---|---|
| guidewire type 1: VisiGlide™ angled tip | Active comparator | Primary use of VisiGlide™ guidewire (angled tip). In case it should not be possible to complete one step toward the therapeutic goal after 8 to max. 12 minutes after start of the examination, the wire system is changed: primary change to VisiGlide™ (straight tip) resp. to VisiGlid2e™ (tip according to the examiner) Receives: Device: VisiGlide™ angled tip; Device: VisiGlide2™ angled tip; Device: VisiGlide™ straight tip; Device: VisiGlide2™ straight tip |
| guidewire type 2: VisiGlide2™ angled tip | Active comparator | Primary use of VisiGlide2™ guidewire (straight tip). In case it should not be possible to complete one step toward the therapeutic goal after 8 to max. 12 minutes after start of the examination, the wire system is changed: primary change to VisiGlide2™ (angled tip) resp. to VisiGlide™ (tip according to the examiner) Receives: Device: VisiGlide™ angled tip; Device: VisiGlide2™ angled tip; Device: VisiGlide™ straight tip; Device: VisiGlide2™ straight tip |
| guidewire type 1: VisiGlide™ straight tip | Active comparator | Primary use of VisiGlide™ guidewire (straight tip). In case it should not be possible to complete one step toward the therapeutic goal after 8 to max. 12 minutes after start of the examination, the wire system is changed: primary change to VisiGlide™ (angled tip) resp. to VisiGlide2™ (tip according to the examiner) Receives: Device: VisiGlide™ angled tip; Device: VisiGlide2™ angled tip; Device: VisiGlide™ straight tip; Device: VisiGlide2™ straight tip |
| guidewire type 2: VisiGlide2™ straight tip | Active comparator | Primary use of VisiGlide2™ guidewire (straight tip). In case it should not be possible to complete one step toward the therapeutic goal after 8 to max. 12 minutes after start of the examination, the wire system is changed: primary change to VisiGlide2™ (angled tip) resp. to VisiGlide™ (tip according to the examiner) Receives: Device: VisiGlide™ angled tip; Device: VisiGlide2™ angled tip; Device: VisiGlide™ straight tip; Device: VisiGlide2™ straight tip |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of successful passages of bilary (pancreatic) stenosis with the different guidewires.
Measured: through study completion, an average of 2 years
Secondary outcomes (1)
Duration of ERCP session
Comparison of time needed for the ERCP session in all study groups
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2018
- Study startMay 2016
- Primary completionOct 2019
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stenosis of Bile DuctStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 453 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Klinikum Stadt Hanau, Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor, Robert Bosch Medical Center
- Responsible party
- Principal investigator, Jorg Albert, Johann Wolfgang Goethe University Hospital
- Investigators
- Jörg G Albert, Principal investigator, Robert Bosch Krankenhaus Stuttgart, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03638700
- Sponsor's protocol ID
- 39/16
- Status last verified
- May 2022
- First submitted
- 13 Jun 2016
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Use of Two High Performance Guidewires in Patients With Stenosis of the Bile Ducts in ERCP: A Randomised Multicenter Trial
- ClinicalTrials.gov ID
- NCT03638700
- Acronym / sponsor ID
- 39/16
- Conditions
- Stenosis of Bile Duct
- Keywords
- stenosis, bile duct, guidewire, ercp
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 453 participants (actual)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Collaborators
- Klinikum Stadt Hanau, Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor, Robert Bosch Medical Center
- Study start
- May 2016
- Primary completion
- Oct 2019 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 20 Aug 2018 (actual)
- 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.
In ERCP guidewires are used for the insertion of endoprostheses and the cannulation of stenosis. This leads to two essential requirements for the wire systems: The use of a (highly) flexible, hydrophilic wire to achieve successful and rapid passage of the narrow passage; for additional intervention, modern wires are equipped with a stable shaft with which e.g. bougies, dilatation catheters, or stents can be introduced. Guidewires are available with angled or straight tips whose use differ regionally. Guidewires with angled tips are used predominantly in Japan, whereas in the Western world incl. Germany straight wires are commonly used. In a recently published study examining the intubation of the native papilla, successful intubation of the papilla was faster with guidewires with angled tips than with guidewires with straight tips. However, this did not result in an effect upon the time-independent rate of the successful papilla intubation.
The investigators test the hypothesis that 1) a higher success rate of the ERCP can be achieved with the use of an angled guidewire than with a straight guidewire and 2) a higher success rate of the ERCP can be achieved with the use of a type 1 guidewire than with a type 2 guidewire
Detailed description
This is a randomized, multicentric study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| guidewire type 1: VisiGlide™ angled tip | Active comparator | Device: VisiGlide™ angled tip, Device: VisiGlide2™ angled tip, Device: VisiGlide™ straight tip, Device: VisiGlide2™ straight tipPrimary use of VisiGlide™ guidewire (angled tip). In case it should not be possible to complete one step toward the therapeutic goal after 8 to max. 12 minutes after start of the examination, the wire system is changed: primary change to VisiGlide™ (straight tip) resp. to VisiGlid2e™ (tip according to the examiner) |
| guidewire type 2: VisiGlide2™ angled tip | Active comparator | Device: VisiGlide™ angled tip, Device: VisiGlide2™ angled tip, Device: VisiGlide™ straight tip, Device: VisiGlide2™ straight tipPrimary use of VisiGlide2™ guidewire (straight tip). In case it should not be possible to complete one step toward the therapeutic goal after 8 to max. 12 minutes after start of the examination, the wire system is changed: primary change to VisiGlide2™ (angled tip) resp. to VisiGlide™ (tip according to the examiner) |
| guidewire type 1: VisiGlide™ straight tip | Active comparator | Device: VisiGlide™ angled tip, Device: VisiGlide2™ angled tip, Device: VisiGlide™ straight tip, Device: VisiGlide2™ straight tipPrimary use of VisiGlide™ guidewire (straight tip). In case it should not be possible to complete one step toward the therapeutic goal after 8 to max. 12 minutes after start of the examination, the wire system is changed: primary change to VisiGlide™ (angled tip) resp. to VisiGlide2™ (tip according to the examiner) |
| guidewire type 2: VisiGlide2™ straight tip | Active comparator | Device: VisiGlide™ angled tip, Device: VisiGlide2™ angled tip, Device: VisiGlide™ straight tip, Device: VisiGlide2™ straight tipPrimary use of VisiGlide2™ guidewire (straight tip). In case it should not be possible to complete one step toward the therapeutic goal after 8 to max. 12 minutes after start of the examination, the wire system is changed: primary change to VisiGlide2™ (angled tip) resp. to VisiGlide™ (tip according to the examiner) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Obstruction of the biliary tract (cross sectional imaging or ultrasonography/lab data
Key exclusion criteria (1 listed)
- Operatively alternated anatomy of the patient
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 |
|---|---|---|
| VisiGlide™ angled tipArm A: Primary use of VisiGlide™ guidewire (angled tip). In case it should not be possible to complete one step toward the therapeutic goal after 8 to max. 12 minutes after start of the examination, the wire system is changed: primary change to VisiGlide™ (straight tip) resp. to VisiGlid2e™ (tip according to the examiner) | Device | guidewire type 1: VisiGlide™ angled tip, guidewire type 1: VisiGlide™ straight tip, guidewire type 2: VisiGlide2™ angled tip, guidewire type 2: VisiGlide2™ straight tip |
| VisiGlide2™ angled tipArm B: Primary use of VisiGlide2™ guidewire (angled tip). In case it should not be possible to complete one step toward the therapeutic goal after 8 to max. 12 minutes after start of the examination, the wire system is changed: primary change to VisiGlide2™ (straight tip) resp. to VisiGlide™ (tip according to the examiner) | Device | guidewire type 1: VisiGlide™ angled tip, guidewire type 1: VisiGlide™ straight tip, guidewire type 2: VisiGlide2™ angled tip, guidewire type 2: VisiGlide2™ straight tip |
| VisiGlide™ straight tipArm C: Primary use of VisiGlide™ guidewire (straight tip). In case it should not be possible to complete one step toward the therapeutic goal after 8 to max. 12 minutes after start of the examination, the wire system is changed: primary change to VisiGlide™ (angled tip) resp. to VisiGlide2™ (tip according to the examiner) | Device | guidewire type 1: VisiGlide™ angled tip, guidewire type 1: VisiGlide™ straight tip, guidewire type 2: VisiGlide2™ angled tip, guidewire type 2: VisiGlide2™ straight tip |
| VisiGlide2™ straight tipArm D: Primary use of VisiGlide2™ guidewire (straight tip). In case it should not be possible to complete one step toward the therapeutic goal after 8 to max. 12 minutes after start of the examination, the wire system is changed: primary change to VisiGlide2™ (angled tip) resp. to VisiGlide1™ (tip according to the examiner) | Device | guidewire type 1: VisiGlide™ angled tip, guidewire type 1: VisiGlide™ straight tip, guidewire type 2: VisiGlide2™ angled tip, guidewire type 2: VisiGlide2™ straight tip |
Primary outcome
Number of successful passages of bilary (pancreatic) stenosis with the different guidewires.
Time frame: through study completion, an average of 2 years
1 secondary outcome
Duration of ERCP session
Time frame: through study completion, an average of 2 years
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 18 May 2022.
- Individual participant dataSharing planned: No
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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.
Jörg G Albert principal investigator
Robert Bosch Krankenhaus Stuttgart, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VisiGlide™ angled tip, VisiGlide2™ angled tip and VisiGlide™ straight tip in people with Stenosis of Bile Duct, run by Johann Wolfgang Goethe University Hospital 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 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 18 May 2022. 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?
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 successful passages of bilary (pancreatic) stenosis with the different guidewires. (time frame: through study completion, an average of 2 years). 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 18 May 2022.