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

NCT ID: NCT00919074

Last Updated: 2014-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2014-12-31

Brief Summary

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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

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Conditions

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Endoscopic Retrograde Cholangiopancreatography (ERCP) Bile Duct Cannulation

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Pancreatic duct stent

Placement of a pancreatic duct stent to facilitate bile duct cannulation

Group Type ACTIVE_COMPARATOR

Pancreatic duct stent

Intervention Type PROCEDURE

Placement of a pancreatic duct stent to facilitate bile duct cannulation

Pancreatic wire

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

Group Type ACTIVE_COMPARATOR

Pancreatic wire placement

Intervention Type PROCEDURE

Placement of a pancreatic wire to facilitate bile duct cannulation

Interventions

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Pancreatic duct stent

Placement of a pancreatic duct stent to facilitate bile duct cannulation

Intervention Type PROCEDURE

Pancreatic wire placement

Placement of a pancreatic wire to facilitate bile duct cannulation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* First time ERCP

Exclusion Criteria

* Successful bile duct cannulation within six minutes
* Planned pancreatic duct therapy
* Planned pancreatobiliary manometry
* Prior successful ERCP
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northwestern University

OTHER

Sponsor Role collaborator

University of Oklahoma

OTHER

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Riad R Azar, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Northwestern University

Chicago, Illinois, United States

Site Status

Washington University in St. Louis

St Louis, Missouri, United States

Site Status

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 22732831 (View on PubMed)

Other Identifiers

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08-0831

Identifier Type: -

Identifier Source: org_study_id