Loop-tipped Guidewire in Selective Biliary Cannulation

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 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

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