Loop-tipped Guidewire in Selective Biliary Cannulation

Study Overview
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Brief Summary
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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.

Official Title
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Loop-tipped Guidewire in Selective Biliary Cannulation: a Prospective, Randomized, Controlled Trial

Conditions
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Choledocholithiasis, Bile Duct Cancer, Pancreatic Cancer, Ampullary Tumor

Intervention / Treatment
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* Device: Biliary cannulation with loop guidewire
* Device: Biliary cannulation with straight guidewire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age > 19 and ability to consent no evidence of significant cardiopulmonary or medical comorbidities precluding participation Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Loop guidewire<br>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<br>* Selective biliary cannulation during endoscopic retrograde cholangiopancreatography<br>|
| Active Comparator: Straight guidewire<br>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<br>* Selective biliary cannulation during endoscopic retrograde cholangiopancreatography<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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

| Outcome Measure | 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). |