Loop-tipped Guidewire in Selective Biliary Cannulation

NCT ID: NCT02028845

Last Updated: 2016-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Choledocholithiasis Bile Duct Cancer Pancreatic Cancer Ampullary Tumor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Biliary cannulation with loop guidewire

Intervention Type DEVICE

Selective biliary cannulation during endoscopic retrograde cholangiopancreatography

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.

Group Type ACTIVE_COMPARATOR

Biliary cannulation with straight guidewire

Intervention Type DEVICE

Selective biliary cannulation during endoscopic retrograde cholangiopancreatography

Interventions

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Biliary cannulation with loop guidewire

Selective biliary cannulation during endoscopic retrograde cholangiopancreatography

Intervention Type DEVICE

Biliary cannulation with straight guidewire

Selective biliary cannulation during endoscopic retrograde cholangiopancreatography

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ajou University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Yoo Byung Moo

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Byung Moo Yoo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Gastroenterology, Ajou University School of Medicine

Locations

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Department of Gastroenterology, Ajou University School of Medicine

Suwon, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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AJIRB-DEV-DE2-13-175

Identifier Type: -

Identifier Source: org_study_id

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