Clinical trial NCT03582540: Early Versus Delayed Double-guidewire Technique in Difficult Biliary Cannulation. (DFG)
Official title: Study Assessing the Interest of the Double-guidewire Technique for Catheterization of the Common Bile Duct.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Catheterization
Cholangiopancreatography
Endoscopic Retrograde Cholangiography
Biliary Cannulation
Difficult Biliary Cannulation
Double-guidewire Technique
Lead sponsor: Société Française d'Endoscopie Digestive
Sponsor class: OTHER
First posted: 2018-07-11
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Biliary cannulation success rate
timeFrame: During the ERCP procedure
Secondary outcomes:
measure: Immediate morbidity
timeFrame: From the start, until 30 minutes after completion of ERCP
measure: Delayed morbidity
timeFrame: 30 minutes after ERCP completion and up to 30 days
measure: procedural time
timeFrame: time from the first guidewire insertion into the pancreatic duct up to the end of cannulation.
Other outcomes:
Locations:
city: Charenton-le-Pont
country: France
facility: Clinique de Bercy
city: Limoges
country: France
facility: Hôpital Dupuytren
city: Marseille
country: France
facility: Hopital Saint Joseph
city: Paris
country: France
facility: Groupe Hospitalier Diaconesses - La Croix Saint-Simon
city: Pessac
country: France
facility: Hôpital Haut Lévêque
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Lyon Sud
city: Tarbes
country: France
facility: Centre Hospitalier de Bigorre
city: Vichy
country: France
facility: Centre Hospitalier de Vichy
Study officials:
affiliation: Société Française d'Endoscopie Digestive
name: ARTHUR LAQUIERE, MD
role: PRINCIPAL_INVESTIGATOR
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