Loop-tipped Guidewire in Selective Biliary Cannulation

NCT02028845 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2016-01-05

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02028845 on ClinicalTrials.gov