Loop-tipped Guidewire in Selective Biliary Cannulation
NCT02028845 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2016-01-05
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. 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.
Conditions
- Choledocholithiasis
- Bile Duct Cancer
- Pancreatic Cancer
- Ampullary Tumor
Interventions
- DEVICE
-
Biliary cannulation with loop guidewire
Selective biliary cannulation during endoscopic retrograde cholangiopancreatography
- DEVICE
-
Biliary cannulation with straight guidewire
Selective biliary cannulation during endoscopic retrograde cholangiopancreatography
Sponsors & Collaborators
-
Ajou University School of Medicine
lead OTHER
Principal Investigators
-
Byung Moo Yoo, MD, PhD · Department of Gastroenterology, Ajou University School of Medicine
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Max Age
- 90 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-01-31
- Primary Completion
- 2015-12-31
- Completion
- 2015-12-31
Countries
- South Korea
Study Locations
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