An interventional study of Double-guidewire cannulation technique in Catheterization, Cholangiopancreatography and Endoscopic Retrograde Cholangiography, sponsored by Société Française d'Endoscopie Digestive. Completed at 8 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-23.
Sponsored by Société Française d'Endoscopie Digestive · Not applicable, Interventional, and Treatment
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.
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.
Société Française d'Endoscopie Digestive is the lead sponsor of 25 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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 The cannulation device is then withdrawn, reloaded with a second guidewire, and reinserted through the working channel of the endoscope to cannulate the common bile duct.
Biliary cannulation success rate
The percentage of biliary cannulation success in both arms.
Time frame: During the ERCP procedure
Immediate morbidity
Any complications (procedure related, clinical or anesthesiological) occurring during the procedure or during the immediate post-intervention period.
Time frame: From the start, until 30 minutes after completion of ERCP
Delayed morbidity
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
Time frame: 30 minutes after ERCP completion and up to 30 days
procedural time
The time taken in minutes between patient randomization (at the first guidewire insertion into the pancreatic duct) and successful biliary cannulation.
Time frame: time from the first guidewire insertion into the pancreatic duct up to the end of cannulation.
Plan to share: No
This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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Société Française d'Endoscopie Digestive