Early Versus Delayed Double-guidewire Technique in Difficult Biliary Cannulation. (DFG)
NCT ID: NCT03582540
Last Updated: 2019-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
150 participants
INTERVENTIONAL
2016-11-02
2019-08-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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 The cannulation device is then withdrawn, reloaded with a second guidewire, and reinserted through the working channel of the endoscope to cannulate the common bile duct.
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.
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 The cannulation device is then withdrawn, reloaded with a second guidewire, and reinserted through the working channel of the endoscope to cannulate the common bile duct.
Interventions
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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 The cannulation device is then withdrawn, reloaded with a second guidewire, and reinserted through the working channel of the endoscope to cannulate the common bile duct.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Société Française d'Endoscopie Digestive
OTHER
Responsible Party
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Dr Arthur Laquiere
Gastroenterologist
Principal Investigators
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ARTHUR LAQUIERE, MD
Role: PRINCIPAL_INVESTIGATOR
Société Française d'Endoscopie Digestive
Locations
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Clinique de Bercy
Charenton-le-Pont, , France
Hôpital Dupuytren
Limoges, , France
Hopital Saint Joseph
Marseille, , France
Groupe Hospitalier Diaconesses - La Croix Saint-Simon
Paris, , France
Hôpital Haut Lévêque
Pessac, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Centre Hospitalier de Bigorre
Tarbes, , France
Centre Hospitalier de Vichy
Vichy, , France
Countries
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References
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Other Identifiers
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ID RCB: 2016-A01016-45
Identifier Type: -
Identifier Source: org_study_id
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