Double Guidewire Technique Versus Transpancreatic Precut in Patients With Repetitive Unintentional Cannulation of the Pancreatic Duct.

August 4, 2020 updated by: Hany Shehab, Cairo University
Difficult cannulation of the common bile duct is encountered in about 10%of ERCP procedures. This frequently happens in the form of repeated unintentional cannulation of the pancreatic duct. Two valid options are available to facilitate cannulation at this point: Double guidewire technique or performing a transpancreatic precut. This is a randomized trial comparing the efficacy and Safety of double guidwire technique versus transpancreatic precut after three unintentional passages of the guidewire into the pancreatic duct.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11562
        • Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • unintentional cannulation of the pancreatic duct 3 times
  • Consenting to join the study

Exclusion Criteria:

  • Previous ERCP with or without previous sphincterotomy

  • Known coagulopathy

    • - Pregnancy
    • - Known acute pancreatitis at the time of procedure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Double guidewire
Procedure: Double guidewire
After the 3rd passage of the guidewire into the pancreatic duct, the catheter will be removed leaving the guidewire in place. The catheter will be re-inserted and a second guidewire will be used and directed above the pancreatic wire in the 11-12 o'clock direction to attempt cannulation of the common bile duct.
Active Comparator: Transpancreatic precut
Procedure: Transpancreatic precut
After the 3rd passage of the guidewire unintentionally into the pancreatic duct, the guidewire will be left in the pancreatic duct, a sphincterotome will be used to cut in the direction of 11-12 o'clock attempting to deroof the pancreatic duct and gain access into the common bile duct. The wire will then be retracted and reinserted in the direction of the cut to attempt cannulation of the common bile duct.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cannulation success
Time Frame: Within 10 minutes
Proportion of patients with successful cannulation of the common bile duct
Within 10 minutes
Rate of post-ERCP pancreatitis
Time Frame: up to 24 hours after the procedure
Proportion of patients suffering post-ERCP pancreatitis
up to 24 hours after the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to successful cannulation
Time Frame: Within 10 minutes
Time to achieve cannulation after the 3rd passage of the guidewire into the pancreatic duct
Within 10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Chair: Hany M Shehab, Kasr-Elaini Faculty of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 15, 2020

Primary Completion (Anticipated)

July 31, 2022

Study Completion (Anticipated)

August 30, 2022

Study Registration Dates

First Submitted

August 4, 2020

First Submitted That Met QC Criteria

August 4, 2020

First Posted (Actual)

August 7, 2020

Study Record Updates

Last Update Posted (Actual)

August 7, 2020

Last Update Submitted That Met QC Criteria

August 4, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DGWRCT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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