NCT02028845

Brief Summary

  • 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
  • Setting:
  • Patients
  • 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 31, 2013

Completed
1 day until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 7, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 5, 2016

Status Verified

January 1, 2016

Enrollment Period

1.9 years

First QC Date

December 31, 2013

Last Update Submit

January 4, 2016

Conditions

CholedocholithiasisBile Duct CancerPancreatic CancerAmpullary Tumor

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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).

Study Arms (2)

Loop guidewire

ACTIVE COMPARATOR

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.

Device: Biliary cannulation with loop guidewire

Straight guidewire

ACTIVE COMPARATOR

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.

Device: Biliary cannulation with straight guidewire

Interventions

Biliary cannulation with loop guidewireDEVICE

Selective biliary cannulation during endoscopic retrograde cholangiopancreatography

Loop guidewire
Biliary cannulation with straight guidewireDEVICE

Selective biliary cannulation during endoscopic retrograde cholangiopancreatography

Straight guidewire

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age \> 19 and ability to consent
  • no evidence of significant cardiopulmonary or medical comorbidities precluding participation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gastroenterology, Ajou University School of Medicine

Suwon, Gyeonggi-do, 443-721, South Korea

Location

MeSH Terms

Conditions

CholedocholithiasisBile Duct NeoplasmsPancreatic Neoplasms

Condition Hierarchy (Ancestors)

Common Bile Duct DiseasesBile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesCholelithiasisBiliary Tract NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Byung Moo Yoo, MD, PhD

    Department of Gastroenterology, Ajou University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 31, 2013

First Posted

January 7, 2014

Study Start

January 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

January 5, 2016

Record last verified: 2016-01

Locations

KR(1)