Comparison of Double Wire Technique With Pancreatic Duct Stent Placement for Difficult Bile Duct Cannulation

December 8, 2014 updated by: Washington University School of Medicine

Comparison of Double Wire Technique With Pancreatic Duct Stent Placement for Difficult Bile Duct Cannulation: a Randomized Clinical Trial

This research project will compare the use of the double wire technique with the placement of a pancreatic duct (PD) stent to achieve deep biliary cannulation without the use of a precut papillotomy. Currently, the data supporting either of these approaches is limited to the referenced case series. More data on the success and complication rates of these techniques are needed. The investigators believe either of these approaches would be preferred by less experienced endoscopists to precut papillotomy. Consequently, it is important to differentiate these techniques and identify which patients may benefit from one or both.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

87

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

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University in St. Louis
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • University of Oklahoma Health Sciences Center

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:

  • First time ERCP

Exclusion Criteria:

  • Successful bile duct cannulation within six minutes
  • Planned pancreatic duct therapy
  • Planned pancreatobiliary manometry
  • Prior successful ERCP

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: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pancreatic duct stent
Placement of a pancreatic duct stent to facilitate bile duct cannulation
Procedure: Pancreatic duct stent
Placement of a pancreatic duct stent to facilitate bile duct cannulation
Active Comparator: Pancreatic wire
Placement of a guidewire into the pancreatic duct to facilitate bile duct cannulation.
Procedure: Pancreatic wire placement
Placement of a pancreatic wire to facilitate bile duct cannulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cannulation success rate
Time Frame: Cannulation is assessed during the index procedure; procedure-related complications are assessed within one week of the procedure
Cannulation is assessed during the index procedure; procedure-related complications are assessed within one week of the procedure

Secondary Outcome Measures

Outcome Measure
Time Frame
Complication rate
Time Frame: One week
One week

Collaborators and Investigators

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

Sponsor

Washington University School of Medicine

Collaborators

Northwestern University
University of Oklahoma

Investigators

  • Principal Investigator: Riad R Azar, MD, Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

September 1, 2008

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

June 10, 2009

First Submitted That Met QC Criteria

June 11, 2009

First Posted (Estimate)

June 12, 2009

Study Record Updates

Last Update Posted (Estimate)

December 9, 2014

Last Update Submitted That Met QC Criteria

December 8, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 08-0831

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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