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

NCT00919074 | Completed DMC

• 1 other identifier: 08-0831
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 3

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.

Conditions

Endoscopic Retrograde Cholangiopancreatography (ERCP); Bile Duct Cannulation

Keywords

Patients undergoing endoscopic retrograde cholangiopancreatography for the first time; Particular focus on patients who meet predefined criteria for a difficult bile duct cannulation

Outcome Measures

Primary Outcomes (1)

• Cannulation success rate

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

Secondary Outcomes (1)

• Complication rate

  One week

Study Arms (2)

Pancreatic duct stent

ACTIVE COMPARATOR

Placement of a pancreatic duct stent to facilitate bile duct cannulation

Procedure: Pancreatic duct stent

Pancreatic wire

ACTIVE COMPARATOR

Placement of a guidewire into the pancreatic duct to facilitate bile duct cannulation.

Procedure: Pancreatic wire placement

Interventions

Pancreatic duct stent PROCEDURE

Placement of a pancreatic duct stent to facilitate bile duct cannulation

Pancreatic duct stent

Pancreatic wire placement PROCEDURE

Placement of a pancreatic wire to facilitate bile duct cannulation

Pancreatic wire

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• First time ERCP

You may not qualify if:

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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Northwestern University: collaborator
• University of Oklahoma: collaborator

Study Sites (3)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Location

Related Publications (1)

• Cote 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 clinical trial. Dig Dis Sci. 2012 Dec;57(12):3271-8. doi: 10.1007/s10620-012-2269-2. Epub 2012 Jun 26.

  PMID: 22732831 RESULT

Study Officials

• Riad R Azar, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2009
• First Posted: June 12, 2009
• Study Start: September 1, 2008
• Primary Completion: January 1, 2011
• Study Completion: December 1, 2014
• Last Updated: December 9, 2014

Record last verified: 2014-12

Locations

US (3)