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

Sponsor

Duke University (Other)

Overall Status

Completed

CT.gov ID

NCT02297750

Collaborator

(none)

161

Enrollment

Location

Arms

Duration (Months)

4.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Endoscopic Retrograde Cholangiopancreatography	Procedure: double-wire technique in patients undergoing ERCP with biliary cannulation Procedure: single-wire technique in patients undergoing ERCP with biliary cannulation	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

161 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Official Title:

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

Study Start Date :

Aug 1, 2012

Actual Primary Completion Date :

Jun 1, 2015

Actual Study Completion Date :

Jun 1, 2015

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Success of biliary cannulation [10 minutes after randomization]
The primary outcome is incidence of successful deep biliary cannulation within 10 minutes.

Secondary Outcome Measures

Success of biliary cannulation [2 days after the procedure]
Number of attempts required for successful biliary cannulation
Time to successful biliary cannulation [2 days after the procedure]
Post-ERCP pancreatitis [2 days after the procedure]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke University Medical Center	Durham	North Carolina	United States	27710

Sponsors and Collaborators

Duke University

Investigators

Principal Investigator: Mahfuzul Haque, MD, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Duke University

ClinicalTrials.gov Identifier:

NCT02297750

Other Study ID Numbers:

Pro00033706

First Posted:

Nov 21, 2014

Last Update Posted:

Oct 26, 2015

Last Verified:

Nov 1, 2014

Keywords provided by Duke University

The focus of the study is double-wire technique versus single wire technique in patients undergoing ERCP with biliary cannulation as the primary objective.

Study Results

No Results Posted as of Oct 26, 2015