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OpenTrials
Completed

NCT Number: NCT02297750

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

double-wire technique in patients undergoing ERCP with biliary cannulation

Procedure

single-wire technique in patients undergoing ERCP with biliary cannulation

Procedure

Primary outcomes

  1. Success of biliary cannulation

    Time frame: 10 minutes after randomization

    The primary outcome is incidence of successful deep biliary cannulation within 10 minutes.

Secondary outcomes

  1. Success of biliary cannulation

    Time frame: 2 days after the procedure

    Number of attempts required for successful biliary cannulation

  2. Time to successful biliary cannulation

    Time frame: 2 days after the procedure

  3. Post-ERCP pancreatitis

    Time frame: 2 days after the procedure

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Nov 21, 2014
Registry last updated
Oct 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.