Loop-tipped Guidewire in Selective Biliary Cannulation

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02028845

Enrollment

200

Registered

2014-01-07

Start date

2014-01-31

Completion date

2015-12-31

Last updated

2016-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ampullary Tumor, Bile Duct Cancer, Choledocholithiasis, Pancreatic Cancer

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.

Interventions

DEVICEBiliary cannulation with loop guidewire

Selective biliary cannulation during endoscopic retrograde cholangiopancreatography

DEVICEBiliary cannulation with straight guidewire

Selective biliary cannulation during endoscopic retrograde cholangiopancreatography

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 90 Years

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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).

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026