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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Northwestern University
University of Oklahoma
Information provided by:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00919074
First received: June 10, 2009
Last updated: June 27, 2011
Last verified: June 2011
History of Changes

June 10, 2009
June 27, 2011
September 2008
January 2011   (final data collection date for primary outcome measure)
Cannulation success rate [ Time Frame: Cannulation is assessed during the index procedure; procedure-related complications are assessed within one week of the procedure ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00919074 on ClinicalTrials.gov Archive Site
Complication rate [ Time Frame: One week ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Comparison of Double Wire Technique With Pancreatic Duct Stent Placement for Difficult Bile Duct Cannulation
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Endoscopic Retrograde Cholangiopancreatography
  • Bile Duct Cannulation
  • Procedure: Pancreatic duct stent
    Placement of a pancreatic duct stent to facilitate bile duct cannulation
  • Procedure: Pancreatic wire placement
    Placement of a pancreatic wire to facilitate bile duct cannulation
  • Active Comparator: Pancreatic duct stent
    Placement of a pancreatic duct stent to facilitate bile duct cannulation
    Intervention: Procedure: Pancreatic duct stent
  • Active Comparator: Pancreatic wire
    Placement of a guidewire into the pancreatic duct to facilitate bile duct cannulation.
    Intervention: Procedure: Pancreatic wire placement
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
December 2011
January 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • First time ERCP

Exclusion Criteria:

  • Successful bile duct cannulation within six minutes
  • Planned pancreatic duct therapy
  • Planned pancreatobiliary manometry
  • Prior successful ERCP
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00919074
08-0831
Yes
Riad R. Azar, Washington University in St. Louis
Washington University School of Medicine
  • Northwestern University
  • University of Oklahoma
Principal Investigator: Riad R Azar, MD Washington University in St. Louis
Washington University School of Medicine
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP