The Use of Guide Wire in Biliary Cannulation: Angled or Straight Tipped Guide Wire?

October 10, 2011 updated by: Hanna Vihervaara, Turku University Hospital
The purpose of the study is to prospectively evaluate the deep biliary cannulation in ERCP with the angled tipped guide wire or the straight tipped guide wire.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients coming to ERCP examination are being divided randomly to two different groups. The deep biliary cannulation is started with predetermined guide wire. If the cannulation does not succeed in two minutes, the procedure is continued as normal.

Study Type

Interventional

Enrollment (Actual)

164

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Turku, Finland, 20521
        • Turku University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • the need for ERCP assessed by a specialist in gastrointestinal surgery

Exclusion Criteria:

  • prior sphincterotomy
  • age under 18
  • age over 90
  • contrast media allergy
  • inability to give informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: angled tipped guide wire
angled tipped guide wire used to deep biliary cannulation
Procedure: angled and straight tipped guide wire
Angled or straight tipped guide wire is used in the beginning of deep biliary cannulation in ERCP . If there is no success, other normal procedures (e.g. double wire cannulation and precut) are performed.
Active Comparator: straight tipped guidewire
straight guide wire used to deep biliary cannulation
Procedure: angled and straight tipped guide wire
Angled or straight tipped guide wire is used in the beginning of deep biliary cannulation in ERCP . If there is no success, other normal procedures (e.g. double wire cannulation and precut) are performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The success rate of deep biliary cannulation
Time Frame: October 2010
October 2010

Secondary Outcome Measures

Outcome Measure
Time Frame
Frequency of post-ERCP pancreatitis
Time Frame: October 2010
October 2010
time spent to deep biliary cannulation
Time Frame: October 2010
October 2010

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Turku University Hospital

Investigators

  • Principal Investigator: Hanna R Vihervaara, Turku University Hospital
  • Study Director: Juha Grönroos, PhD, Turku University Hospital
  • Study Director: Paulina Salminen, PhD, Turku University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

October 5, 2009

First Submitted That Met QC Criteria

October 26, 2009

First Posted (Estimate)

October 27, 2009

Study Record Updates

Last Update Posted (Estimate)

October 12, 2011

Last Update Submitted That Met QC Criteria

October 10, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 23/180/2009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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