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

Not Applicable

Completed

• Conditions: Endoscopic Retrograde Cholangiopancreatography (ERCP); Bile Duct Cannulation
• Interventions: Procedure: Pancreatic wire placement; Procedure: Pancreatic duct stent

• Registration Number: NCT00919074
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2009-06-10
• Study First Submitted QC: 2009-06-11
• Study First Posted: 2009-06-12
• Primary Completion: 2011-01
• Status Verified: 2014-12
• Study Completion: 2014-12
• Last Update Submitted: 2014-12-08
• Last Update Posted: 2014-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pancreatic wire	Pancreatic wire placement	Placement of a guidewire into the pancreatic duct to facilitate bile duct cannulation.
Pancreatic duct stent	Pancreatic duct stent	Placement of a pancreatic duct stent to facilitate bile duct cannulation

Primary Outcome Measures

Name	Time	Method
Cannulation success rate	Cannulation is assessed during the index procedure; procedure-related complications are assessed within one week of the procedure

Secondary Outcome Measures

Name	Time	Method
Complication rate	One week

Trial Locations

Locations (3)

Washington University in St. Louis; 🇺🇸 St. Louis, Missouri, United States

University of Oklahoma Health Sciences Center; 🇺🇸 Oklahoma City, Oklahoma, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States