Loop-tipped Guidewire in Selective Biliary Cannulation

January 4, 2016 updated by: Yoo Byung Moo, Ajou University School of Medicine

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

  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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi
      • Suwon, Gyeonggi, Korea, Republic of, 443-721
        • Department of Gastroenterology, Ajou University School of Medicine

Participation Criteria

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.

Eligibility Criteria

Ages Eligible for Study

20 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Selective biliary cannulation during endoscopic retrograde cholangiopancreatography
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
Selective biliary cannulation during endoscopic retrograde cholangiopancreatography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The cannulation success rate
Time Frame: Up to 9 months, The primary outcome measure will be assessed after the enrollment of patients (anticipated time: 2014/08/30).
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
Time Frame
The duration of the cannulation, immediate and late complications.
Time Frame: Up to 9 months, The secondary outcome measure will be assessed after the enrollment of patients (anticipated time: 2014/08/30).
Up to 9 months, The secondary outcome measure will be assessed after the enrollment of patients (anticipated time: 2014/08/30).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ajou University School of Medicine

Investigators

  • Principal Investigator: Byung Moo Yoo, MD, PhD, Department of Gastroenterology, Ajou University School of Medicine

Study record dates

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 Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

December 31, 2013

First Submitted That Met QC Criteria

January 5, 2014

First Posted (Estimate)

January 7, 2014

Study Record Updates

Last Update Posted (Estimate)

January 5, 2016

Last Update Submitted That Met QC Criteria

January 4, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AJIRB-DEV-DE2-13-175

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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