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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Washington University School of Medicine.
Recruitment status was  Active, not recruiting
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
  Purpose

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.


Condition Intervention
Endoscopic Retrograde Cholangiopancreatography
Bile Duct Cannulation
Procedure: Pancreatic duct stent
Procedure: Pancreatic wire placement

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Comparison of Double Wire Technique With Pancreatic Duct Stent Placement for Difficult Bile Duct Cannulation: a Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Complication rate [ Time Frame: One week ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: September 2008
Estimated Study Completion Date: December 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • First time ERCP

Exclusion Criteria:

  • Successful bile duct cannulation within six minutes
  • Planned pancreatic duct therapy
  • Planned pancreatobiliary manometry
  • Prior successful ERCP
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00919074

Locations
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Missouri
Washington University in St. Louis
St. Louis, Missouri, United States, 63110
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Sponsors and Collaborators
Washington University School of Medicine
Northwestern University
University of Oklahoma
Investigators
Principal Investigator: Riad R Azar, MD Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Riad R. Azar, Washington University in St. Louis
ClinicalTrials.gov Identifier: NCT00919074     History of Changes
Other Study ID Numbers: 08-0831
Study First Received: June 10, 2009
Last Updated: June 27, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
Patients undergoing endoscopic retrograde cholangiopancreatography for the first time
Particular focus on patients who meet predefined criteria for a difficult bile duct cannulation

ClinicalTrials.gov processed this record on November 27, 2014