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

Endoscopic Retrograde Cholangiopancreatography (ERCP) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00919074
• Other study ID #: 08-0831
• Status: Completed
• Phase: N/A
• First received: June 10, 2009
• Last updated: December 8, 2014
• Start date: September 2008
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: December 2014
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bile Duct Cannulation
• Endoscopic Retrograde Cholangiopancreatography (ERCP)

Intervention

Procedure:
• Pancreatic duct stent
Placement of a pancreatic duct stent to facilitate bile duct cannulation
• Pancreatic wire placement
Placement of a pancreatic wire to facilitate bile duct cannulation

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	Washington University in St. Louis	St. Louis	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
Washington University School of Medicine	Northwestern University, University of Oklahoma

Country where clinical trial is conducted

United States, 

References & Publications (1)

Coté GA, Mullady DK, Jonnalagadda SS, Keswani RN, Wani SB, Hovis CE, Ammar T, Al-Lehibi A, Edmundowicz SA, Komanduri S, Azar RR. Use of a pancreatic duct stent or guidewire facilitates bile duct access with low rates of precut sphincterotomy: a randomized — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cannulation success rate		Cannulation is assessed during the index procedure; procedure-related complications are assessed within one week of the procedure	No
Secondary	Complication rate		One week	Yes