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OpenTrials
Completed

NCT Number: NCT00919074

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

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University, Chicago, Illinois, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • First time ERCP

Exclusion criteria

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

Treatment and study plan

Pancreatic duct stent

Procedure

Placement of a pancreatic duct stent to facilitate bile duct cannulation

Pancreatic wire placement

Procedure

Placement of a pancreatic wire to facilitate bile duct cannulation

Primary outcomes

  1. Cannulation success rate

    Time frame: Cannulation is assessed during the index procedure; procedure-related complications are assessed within one week of the procedure

Secondary outcomes

  1. Complication rate

    Time frame: One week

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Northwestern University
  • University of Oklahoma

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2011
Study completion
2014
First posted
Jun 12, 2009
Registry last updated
Dec 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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