Loop-tipped Guidewire in Selective Biliary Cannulation

Not Applicable

Completed

• Conditions: Bile Duct Cancer; Ampullary Tumor; Pancreatic Cancer; Choledocholithiasis
• Interventions: Device: Biliary cannulation with straight guidewire; Device: Biliary cannulation with loop guidewire

• Registration Number: NCT02028845
• Lead Sponsor: Ajou University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-31
• Study Start: 2014-01
• Study First Submitted QC: 2014-01-05
• Study First Posted: 2014-01-07
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-04
• Last Update Posted: 2016-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Straight guidewire	Biliary cannulation with 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.
Loop guidewire	Biliary cannulation with 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.

Primary Outcome Measures

Name	Time	Method
The cannulation success rate	Up to 9 months, The primary outcome measure will be assessed after the enrollment of patients (anticipated time: 2014/08/30).

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Gastroenterology, Ajou University School of Medicine; 🇰🇷 Suwon, Gyeonggi, Korea, Republic of