CholedocholithiasisNCT02028845
Loop-tipped Guidewire in Selective Biliary Cannulation
A study testing Biliary cannulation with loop guidewire and Biliary cannulation with straight guidewire in people with Choledocholithiasis and Bile Duct Cancer, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
1. Background Advanced guidewires with a U-shaped tip could effectively cross the long or multi-occlusive segment smoothly and go into the distal outflow vessel. The guidewire looping technique is a safe and effective method for the recanalization of the occluded lesions in infrapopliteal vessels. 2. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Choledocholithiasis, Bile Duct Cancer, Pancreatic Cancer
- What is being tested?
- Biliary cannulation with loop guidewire and Biliary cannulation with straight guidewire
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2014to Dec 2015
- 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age > 19 and ability to consent
- no evidence of significant cardiopulmonary or medical comorbidities precluding participation
Who cannot join
- Known gastroduodenal anatomic abnormalities
- Coagulation disorders (international normalized ratio > 1.5 or platelet count < 50000 cells/cubic millimeter)
- Prior gastric surgery,endoscopic retrograde cholangiopancreatography
- Pregnancy
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Gastroenterology, Ajou University School of Medicine
Suwon, Gyeonggi-do, 443-721
About this study
Official title: Loop-tipped Guidewire in Selective Biliary Cannulation: a Prospective, Randomized, Controlled Trial
- Background
- Advanced guidewires with a U-shaped tip could effectively cross the long or multi-occlusive segment smoothly and go into the distal outflow vessel.
- The guidewire looping technique is a safe and effective method for the recanalization of the occluded lesions in infrapopliteal vessels.
Read more
- Objective - To compare the performance a loop-tipped guidewire with a straight-tipped guidewire in achieving successful deep biliary cannulation.
- Design
- Prospective randomized trial.
- Setting:
- Tertiary-care medical center
- Patients
- This study will involve 192 patients with biliary diseases which require endoscopic retrograde cholangiopancreatography.
- Intervention - Cannulation of bile duct by using a loop-tipped guidewire or a straight-tipped guidewire
- Main outcome measurements - Compare the cannulation success rate, the duration of the cannulation, immediate and late complications.
- Being tested
- Biliary cannulation with loop guidewire, Biliary cannulation with straight guidewire
- Medical subject headings
- Choledocholithiasis, Bile Duct Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biliary cannulation with loop guidewireDevice
Selective biliary cannulation during endoscopic retrograde cholangiopancreatography
Biliary cannulation with straight guidewireDevice
Selective biliary cannulation during endoscopic retrograde cholangiopancreatography
| Study group | Role | What they receive |
|---|---|---|
| Loop guidewire | Active comparator | This study has two arms. We will compare the performance of a loop-tipped guidewire with a straight-tipped guidewire in achieving successful deep biliary cannulation with loop guidewire. Receives: Device: Biliary cannulation with loop guidewire |
| Straight guidewire | Active comparator | This study has two arms. We will compare the performance of a loop-tipped guidewire with a straight-tipped guidewire in achieving successful deep biliary cannulation with straight guidewire. Receives: Device: Biliary cannulation with straight guidewire |
What is being measured
The primary outcome is the main question the study is designed to answer.
The cannulation success rate
Measured: Up to 9 months, The primary outcome measure will be assessed after the enrollment of patients (anticipated time: 2014/08/30).
Secondary outcomes (1)
The duration of the cannulation, immediate and late complications.
Measured: Up to 9 months, The secondary outcome measure will be assessed after the enrollment of patients (anticipated time: 2014/08/30).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholedocholithiasisStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yoo Byung Moo, Ajou University School of Medicine
- Investigators
- Byung Moo Yoo, MD, PhD, Principal investigator, Department of Gastroenterology, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02028845
- Sponsor's protocol ID
- AJIRB-DEV-DE2-13-175
- Status last verified
- Jan 2016
- First submitted
- 31 Dec 2013
- Last updated
- 5 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Loop-tipped Guidewire in Selective Biliary Cannulation: a Prospective, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT02028845
- Acronym / sponsor ID
- AJIRB-DEV-DE2-13-175
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 7 Jan 2014 (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.
- Background
- Advanced guidewires with a U-shaped tip could effectively cross the long or multi-occlusive segment smoothly and go into the distal outflow vessel.
- The guidewire looping technique is a safe and effective method for the recanalization of the occluded lesions in infrapopliteal vessels.
- Objective - To compare the performance a loop-tipped guidewire with a straight-tipped guidewire in achieving successful deep biliary cannulation.
- Design
- Prospective randomized trial.
- Setting:
- Tertiary-care medical center
- Patients
- This study will involve 192 patients with biliary diseases which require endoscopic retrograde cholangiopancreatography.
- Intervention - Cannulation of bile duct by using a loop-tipped guidewire or a straight-tipped guidewire
- Main outcome measurements - Compare the cannulation success rate, the duration of the cannulation, immediate and late complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Loop guidewire | Active comparator | Device: Biliary cannulation with loop guidewireThis study has two arms. We will compare the performance of a loop-tipped guidewire with a straight-tipped guidewire in achieving successful deep biliary cannulation with loop guidewire. |
| Straight guidewire | Active comparator | Device: Biliary cannulation with straight guidewireThis study has two arms. We will compare the performance of a loop-tipped guidewire with a straight-tipped guidewire in achieving successful deep biliary cannulation with straight guidewire. |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age > 19 and ability to consent
- no evidence of significant cardiopulmonary or medical comorbidities precluding participation
Key exclusion criteria (4 listed)
- Known gastroduodenal anatomic abnormalities
- Coagulation disorders (international normalized ratio > 1.5 or platelet count < 50000 cells/cubic millimeter)
- Prior gastric surgery,endoscopic retrograde cholangiopancreatography
- Pregnancy
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 |
|---|---|---|
| Biliary cannulation with loop guidewireSelective biliary cannulation during endoscopic retrograde cholangiopancreatography | Device | Loop guidewire |
| Biliary cannulation with straight guidewireSelective biliary cannulation during endoscopic retrograde cholangiopancreatography | Device | Straight guidewire |
Primary outcome
The cannulation success rate
Time frame: Up to 9 months, The primary outcome measure will be assessed after the enrollment of patients (anticipated time: 2014/08/30).
1 secondary outcome
The duration of the cannulation, immediate and late complications.
Time frame: Up to 9 months, The secondary outcome measure will be assessed after the enrollment of patients (anticipated time: 2014/08/30).
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 5 Jan 2016.
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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.
Byung Moo Yoo, MD, PhD principal investigator
Department of Gastroenterology, Ajou University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biliary cannulation with loop guidewire and Biliary cannulation with straight guidewire in people with Choledocholithiasis and Bile Duct Cancer, run by Ajou University School of Medicine at 1 site in South Korea.
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: finished, as of the sponsor's last update on 5 Jan 2016. 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 South Korea. 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 cannulation success rate (time frame: Up to 9 months, The primary outcome measure will be assessed after the enrollment of patients (anticipated time: 2014/08/30).). 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 5 Jan 2016.