2014-01
2015-12
2015-12
200
NCT02028845
Ajou University School of Medicine
Ajou University School of Medicine
INTERVENTIONAL
Loop-tipped Guidewire in Selective Biliary Cannulation
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. 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.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2013-12-31 | N/A | 2016-01-04 |
2014-01-05 | N/A | 2016-01-05 |
2014-01-07 | N/A | 2016-01 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| ACTIVE_COMPARATOR: 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. | DEVICE: Biliary cannulation with loop guidewire
|
| ACTIVE_COMPARATOR: 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. | DEVICE: Biliary cannulation with straight guidewire
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| The cannulation success rate | Up to 9 months, The primary outcome measure will be assessed after the enrollment of patients (anticipated time: 2014/08/30). |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| The duration of the cannulation, immediate and late complications. | Up to 9 months, The secondary outcome measure will be assessed after the enrollment of patients (anticipated time: 2014/08/30). |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
20 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
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