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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
Ajou University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Choledocholithiasis

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

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

First Posted
December 31, 2013
Last Updated
January 4, 2016
Sponsor
Ajou University School of Medicine
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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

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Loop-tipped Guidewire in Selective Biliary Cannulation

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