Loop-tipped Guidewire in Selective Biliary Cannulation

Ajou University School of Medicine

Status: Completed

Conditions: Bile Duct Cancer; Choledocholithiasis; Ampullary Tumor; Pancreatic Cancer

Treatments: Device: Biliary cannulation with loop guidewire; Device: Biliary cannulation with straight guidewire

Study type: Interventional

Funder types: Other

Identifiers

NCT02028845

AJIRB-DEV-DE2-13-175

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 20 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Loop guidewire

Active Comparator group

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.

Treatment:

Device: Biliary cannulation with loop guidewire

Straight guidewire

Active Comparator group

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 straight guidewire.

Treatment:

Device: Biliary cannulation with straight guidewire