Optimal Timing of Double-Wire Technique For Biliary Cannulation at ERCP

The purpose of this study is to give doctors who perform Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures a better idea as to the best techniques to use in order to examine the bile duct as quickly and safely as possible.

Study Overview

• Status: Completed
• Conditions: Endoscopic Retrograde Cholangiopancreatography
• Intervention / Treatment: Procedure: single-wire technique in patients undergoing ERCP with biliary cannulation; Procedure: double-wire technique in patients undergoing ERCP with biliary cannulation

Detailed Description

Sometimes, in the course of a regular ERCP procedure, techniques used by the doctor to pass a wire into the bile duct can result in the pancreas duct being entered instead. When this happens, the doctor may either remove the wire (known as "single wire" technique) or leave it in and use a second wire ("double wire") to enter the bile duct. This study will try to determine whether the "double wire" technique or the "single wire" technique removing the wire is the safest and most efficient.

• Study Type: Interventional
• Enrollment (Actual): 161
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients undergoing ERCP with primary intent to cannulate the bile duct
2. Written informed consent

Exclusion Criteria:

1. Age < 18 years
2. Non-naive papilla (previous sphincterotomy)
3. Surgically altered anatomy
4. Known/suspected pancreas divisum
5. Suspected SOD/biliary manometry
6. Prior ERCP/stent within 3 months
7. ERCP performed in the Operating Room or at Duke North
8. Pregnancy/breast-feeding

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: single wire technique; single wire technique in patients undergoing ERCP with biliary cannulation	Procedure: single-wire technique in patients undergoing ERCP with biliary cannulation
Active Comparator: Double wire technique; double-wire technique in patients undergoing ERCP with biliary cannulation	Procedure: double-wire technique in patients undergoing ERCP with biliary cannulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success of biliary cannulation	The primary outcome is incidence of successful deep biliary cannulation within 10 minutes.	10 minutes after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success of biliary cannulation	Number of attempts required for successful biliary cannulation	2 days after the procedure
Time to successful biliary cannulation		2 days after the procedure
Post-ERCP pancreatitis		2 days after the procedure

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Mahfuzul Haque, MD, Duke University

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: November 19, 2014
• First Submitted That Met QC Criteria: November 20, 2014
• First Posted (Estimate): November 21, 2014

Study Record Updates

• Last Update Posted (Estimate): October 26, 2015
• Last Update Submitted That Met QC Criteria: October 23, 2015
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: The focus of the study is double-wire technique versus single wire technique in patients undergoing ERCP with biliary cannulation as the primary objective.
• Other Study ID Numbers: Pro00033706