NCT02297750

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
161

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

November 19, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 21, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

October 26, 2015

Status Verified

November 1, 2014

Enrollment Period

2.8 years

First QC Date

November 19, 2014

Last Update Submit

October 23, 2015

Conditions

Endoscopic Retrograde Cholangiopancreatography

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.

Outcome Measures

Primary Outcomes (1)

  • Success of biliary cannulation

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

    10 minutes after randomization

Secondary Outcomes (3)

  • Success of 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

Study Arms (2)

single wire technique

ACTIVE COMPARATOR

single wire technique in patients undergoing ERCP with biliary cannulation

Procedure: single-wire technique in patients undergoing ERCP with biliary cannulation

Double wire technique

ACTIVE COMPARATOR

double-wire technique in patients undergoing ERCP with biliary cannulation

Procedure: double-wire technique in patients undergoing ERCP with biliary cannulation

Interventions

double-wire technique in patients undergoing ERCP with biliary cannulationPROCEDURE
Double wire technique
single-wire technique in patients undergoing ERCP with biliary cannulationPROCEDURE
single wire technique

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Study Officials

  • Mahfuzul Haque, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2014

First Posted

November 21, 2014

Study Start

August 1, 2012

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

October 26, 2015

Record last verified: 2014-11

Locations

US(1)