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

NCT03582540 | Completed

• 1 other identifier: ID RCB: 2016-A01016-45
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Catheterization; Cholangiopancreatography; Endoscopic Retrograde Cholangiography; Biliary Cannulation; Difficult Biliary Cannulation; Double-guidewire Technique

Outcome Measures

Primary Outcomes (1)

• Biliary cannulation success rate

  The percentage of biliary cannulation success in both arms.

  During the ERCP procedure

Secondary Outcomes (3)

• Immediate morbidity

  From the start, until 30 minutes after completion of ERCP

• Delayed morbidity

  30 minutes after ERCP completion and up to 30 days

• procedural time

  time from the first guidewire insertion into the pancreatic duct up to the end of cannulation.

Study Arms (2)

early double-guidewire technique (DGT)

ACTIVE COMPARATOR

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

delayed double-guidewire technique (DGT)

ACTIVE COMPARATOR

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

Interventions

Double-guidewire cannulation technique PROCEDURE

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 The cannulation device is then withdrawn, reloaded with a second guidewire, and reinserted through the working channel of the endoscope to cannulate the common bile duct.

delayed double-guidewire technique (DGT); early double-guidewire technique (DGT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Société Française d'Endoscopie Digestive: lead

Study Sites (8)

Clinique de Bercy

Charenton-le-Pont, 94220, France

Location

Hôpital Dupuytren

Limoges, 87042, France

Location

Hopital Saint Joseph

Marseille, 13008, France

Location

Groupe Hospitalier Diaconesses - La Croix Saint-Simon

Paris, 75020, France

Location

Hôpital Haut Lévêque

Pessac, 33600, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

Centre Hospitalier de Bigorre

Tarbes, 65013, France

Location

Centre Hospitalier de Vichy

Vichy, 03207, France

Location

Related Publications (24)

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Study Officials

• ARTHUR LAQUIERE, MD

  Société Française d'Endoscopie Digestive

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gastroenterologist

Model Details: 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 DGT immediately and the delayed arm uses the DGT only if 10 more minutes of conventional cannulation technique does not allow biliary cannulation.

Study Record Dates

• First Submitted: June 28, 2018
• First Posted: July 11, 2018
• Study Start: November 2, 2016
• Primary Completion: July 30, 2019
• Study Completion: August 30, 2019
• Last Updated: September 23, 2019

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (8)