Loop-tipped Guidewire in Selective Biliary Cannulation
Primary Purpose
Choledocholithiasis, Bile Duct Cancer, Pancreatic Cancer
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Biliary cannulation with loop guidewire
Biliary cannulation with straight guidewire
Sponsored by
About this trial
This is an interventional treatment trial for Choledocholithiasis
Eligibility Criteria
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
Sites / Locations
- Department of Gastroenterology, Ajou University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Loop guidewire
Straight guidewire
Arm 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.
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.
Outcomes
Primary Outcome Measures
The cannulation success rate
Secondary Outcome Measures
The duration of the cannulation, immediate and late complications.
Full Information
NCT ID
NCT02028845
First Posted
December 31, 2013
Last Updated
January 4, 2016
Sponsor
Ajou University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02028845
Brief Title
Loop-tipped Guidewire in Selective Biliary Cannulation
Official Title
Loop-tipped Guidewire in Selective Biliary Cannulation: a Prospective, Randomized, Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ajou University School of Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Objective - To compare the performance a loop-tipped guidewire with a straight-tipped guidewire in achieving successful deep biliary cannulation.
Design
- Prospective randomized trial.
Setting:
- Tertiary-care medical center
Patients
- This study will involve 192 patients with biliary diseases which require endoscopic retrograde cholangiopancreatography.
Intervention - Cannulation of bile duct by using a loop-tipped guidewire or a straight-tipped guidewire
Main outcome measurements - Compare the cannulation success rate, the duration of the cannulation, immediate and late complications.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Choledocholithiasis, Bile Duct Cancer, Pancreatic Cancer, Ampullary Tumor
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Loop guidewire
Arm Type
Active Comparator
Arm 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.
Arm Title
Straight guidewire
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Biliary cannulation with loop guidewire
Intervention Description
Selective biliary cannulation during endoscopic retrograde cholangiopancreatography
Intervention Type
Device
Intervention Name(s)
Biliary cannulation with straight guidewire
Intervention Description
Selective biliary cannulation during endoscopic retrograde cholangiopancreatography
Primary Outcome Measure Information:
Title
The cannulation success rate
Time Frame
Up to 9 months, The primary outcome measure will be assessed after the enrollment of patients (anticipated time: 2014/08/30).
Secondary Outcome Measure Information:
Title
The duration of the cannulation, immediate and late complications.
Time Frame
Up to 9 months, The secondary outcome measure will be assessed after the enrollment of patients (anticipated time: 2014/08/30).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Byung Moo Yoo, MD, PhD
Organizational Affiliation
Department of Gastroenterology, Ajou University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Gastroenterology, Ajou University School of Medicine
City
Suwon
State/Province
Gyeonggi
ZIP/Postal Code
443-721
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Loop-tipped Guidewire in Selective Biliary Cannulation
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