Brief Title
Loop-tipped Guidewire in Selective Biliary Cannulation
Official Title
Loop-tipped Guidewire in Selective Biliary Cannulation: a Prospective, Randomized, Controlled Trial
Brief 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.
Study Type
Interventional
Primary Outcome
The cannulation success rate
Secondary Outcome
The duration of the cannulation, immediate and late complications.
Condition
Choledocholithiasis
Intervention
Biliary cannulation with loop guidewire
Study Arms / Comparison Groups
Loop guidewire
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
200
Start Date
January 2014
Completion Date
December 2015
Primary Completion Date
December 2015
Eligibility Criteria
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
Gender
All
Ages
20 Years - 90 Years
Accepts Healthy Volunteers
No
Contacts
Byung Moo Yoo, MD, PhD, ,
Location Countries
Korea, Republic of
Location Countries
Korea, Republic of
Administrative Informations
NCT ID
NCT02028845
Organization ID
AJIRB-DEV-DE2-13-175
Responsible Party
Principal Investigator
Study Sponsor
Ajou University School of Medicine
Study Sponsor
Byung Moo Yoo, MD, PhD, Principal Investigator, Department of Gastroenterology, Ajou University School of Medicine
Verification Date
January 2016