Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
200 participants
INTERVENTIONAL
2014-01-31
2015-12-31
Brief Summary
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* 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. Objective - To compare the performance a loop-tipped guidewire with a straight-tipped guidewire in achieving successful deep biliary cannulation.
3. Design
\- Prospective randomized trial.
4. Setting:
\- Tertiary-care medical center
5. Patients
\- This study will involve 192 patients with biliary diseases which require endoscopic retrograde cholangiopancreatography.
6. Intervention - Cannulation of bile duct by using a loop-tipped guidewire or a straight-tipped guidewire
7. Main outcome measurements - Compare the cannulation success rate, the duration of the cannulation, immediate and late complications.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Loop guidewire
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.
Biliary cannulation with loop guidewire
Selective biliary cannulation during endoscopic retrograde cholangiopancreatography
Straight guidewire
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.
Biliary cannulation with straight guidewire
Selective biliary cannulation during endoscopic retrograde cholangiopancreatography
Interventions
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Biliary cannulation with loop guidewire
Selective biliary cannulation during endoscopic retrograde cholangiopancreatography
Biliary cannulation with straight guidewire
Selective biliary cannulation during endoscopic retrograde cholangiopancreatography
Eligibility Criteria
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Inclusion Criteria
* no evidence of significant cardiopulmonary or medical comorbidities precluding participation
Exclusion Criteria
* Coagulation disorders (international normalized ratio \> 1.5 or platelet count \< 50000 cells/cubic millimeter)
* Prior gastric surgery,endoscopic retrograde cholangiopancreatography
* Pregnancy
20 Years
90 Years
ALL
No
Sponsors
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Ajou University School of Medicine
OTHER
Responsible Party
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Yoo Byung Moo
Assistant Professor
Principal Investigators
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Byung Moo Yoo, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Gastroenterology, Ajou University School of Medicine
Locations
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Department of Gastroenterology, Ajou University School of Medicine
Suwon, Gyeonggi-do, South Korea
Countries
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Other Identifiers
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AJIRB-DEV-DE2-13-175
Identifier Type: -
Identifier Source: org_study_id
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