Early Versus Delayed Double-guidewire Technique in Difficult Biliary Cannulation. (DFG) (DFG)

September 20, 2019 updated by: Dr Arthur Laquiere, Société Française d'Endoscopie Digestive

Study Assessing the Interest of the Double-guidewire Technique for Catheterization of the Common Bile Duct.

This is a prospective randomized comparative multicentric study. Briefly, we will analyze the technical success, performance and clinical outcomes of early versus delayed double-guidewire technique (DGT) in difficult biliary cannulation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a prospective study performed in 20 tertiary medical centers in France. We aim to recruit 150 patients from 2016 to 2020. Patients with a native papilla scheduled for ERCP (endoscopic retrograde cholangiopancreatography) are screened for the study. Patients with a difficult biliary cannulation are included in the study if the guidewire is inserted in the pancreatic duct. At that point, patients are randomized in two arms: early versus delayed DGT. The early arm attempts biliary cannulation using the double-guidewire technique immediately and the delayed arm uses the double-guidewire technique only if 10 more minutes of standard cannulation technique does not allow biliary cannulation. The primary outcome is the biliary cannulation rate success. Secondary outcomes are complications rate and performance of the technique in both arms. Follow-up is 30 days.

Study Type

Interventional

Enrollment (Actual)

150

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

  • France
      • Charenton-le-Pont, France, 94220
        • Clinique de Bercy
      • Limoges, France, 87042
        • Hôpital Dupuytren
      • Marseille, France, 13008
        • Hopital Saint Joseph
      • Paris, France, 75020
        • Groupe Hospitalier Diaconesses - La Croix Saint-Simon
      • Pessac, France, 33600
        • Hopital Haut Leveque
      • Pierre-Bénite, France, 69495
        • Centre Hospitalier Lyon Sud
      • Tarbes, France, 65013
        • Centre Hospitalier de Bigorre
      • Vichy, France, 03207
        • Centre Hospitalier de Vichy

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients 18 years old and more
  • Native papilla
  • Clinical indications of ERCP
  • Difficult biliary cannulation defined by unintentional guidewire insertion into the pancreatic duct before biliary cannulation is successful
  • Informed consent completed by the patient

Exclusion Criteria:

  • Contraindication to upper gastrointestinal endoscopy
  • ERCP with direct biliary cannulation success
  • ERCP with inability to cannulate the bile duct nor the pancreatic duct
  • Coagulation or hemostasis disorder (TP < 60%, TCA> 40 sec. et plaquettes < 60000/mm3).
  • Patient under active antiaggregant or anticoagulant medication other than aspirin
  • Endoscopic treatment of chronic pancreatitis
  • Pregnancy or breastfeeding
  • ERCP performed by another operator than an investigator
  • Patient's voluntary withdrawal
  • Withdrawal decision by the investigator or sponsor

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: early double-guidewire technique (DGT)
First arm: early double-guidewire technique The early arm attempts biliary cannulation using the DGT immediately once the guidewire is inserted in the pancreatic duct in cases of difficult biliary cannulation.
Procedure: Double-guidewire cannulation technique
With the DGT, a guidewire is first inserted deep into the PD. The cannulation device is then withdrawn, reloaded with a second guidewire, and reinserted through the working channel of the endoscope to cannulate the common bile duct.
ACTIVE_COMPARATOR: delayed double-guidewire technique (DGT)
In the delayed arm, once the guidewire is inserted in the pancreatic duct, the operator continues to attempt biliary cannulation with conventional technique (contrast- or guidewire-assisted). DGT is used only if 10 more minutes of conventional cannulation technique does not allow biliary access.
Procedure: Double-guidewire cannulation technique
With the DGT, a guidewire is first inserted deep into the PD. The cannulation device is then withdrawn, reloaded with a second guidewire, and reinserted through the working channel of the endoscope to cannulate the common bile duct.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biliary cannulation success rate
Time Frame: During the ERCP procedure
The percentage of biliary cannulation success in both arms.
During the ERCP procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immediate morbidity
Time Frame: From the start, until 30 minutes after completion of ERCP
Any complications (procedure related, clinical or anesthesiological) occurring during the procedure or during the immediate post-intervention period.
From the start, until 30 minutes after completion of ERCP
Delayed morbidity
Time Frame: 30 minutes after ERCP completion and up to 30 days
Morbidities occurring more than 30 minutes and up to 1 month after ERCP completion. Special attention will be taken for bowel perforation, gastrointestinal bleeding and acute pancreatitis
30 minutes after ERCP completion and up to 30 days
procedural time
Time Frame: time from the first guidewire insertion into the pancreatic duct up to the end of cannulation.
The time taken in minutes between patient randomization (at the first guidewire insertion into the pancreatic duct) and successful biliary cannulation.
time from the first guidewire insertion into the pancreatic duct up to the end of cannulation.

Collaborators and Investigators

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

Sponsor

Société Française d'Endoscopie Digestive

Investigators

  • Principal Investigator: ARTHUR LAQUIERE, MD, Société Française d'Endoscopie Digestive

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (ACTUAL)

November 2, 2016

Primary Completion (ACTUAL)

July 30, 2019

Study Completion (ACTUAL)

August 30, 2019

Study Registration Dates

First Submitted

June 28, 2018

First Submitted That Met QC Criteria

July 10, 2018

First Posted (ACTUAL)

July 11, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 23, 2019

Last Update Submitted That Met QC Criteria

September 20, 2019

Last Verified

June 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • ID RCB: 2016-A01016-45

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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