Biliary Cannulation, Catheterization, Cholangiopancreatography, Difficult Biliary Cannulation, Double-guidewire Technique, Endoscopic Retrograde Cholangiography
Conditions
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.
Interventions
PROCEDUREDouble-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 The cannulation device is then withdrawn, reloaded with a second guidewire, and reinserted through the working channel of the endoscope to cannulate the common bile duct.
Sponsors
Société Française d'Endoscopie Digestive
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biliary cannulation success rate | During the ERCP procedure | The percentage of biliary cannulation success in both arms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immediate morbidity | 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. |
| Delayed morbidity | 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 |
| procedural time | 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. |
Countries
France
Outcome results
None listed