Common Bile Duct Diseases, Double Guidewire, Endoscopic Retrograde Cholangiopancreatography, Precut, Transpancreatic Precut
Conditions
Brief summary
Difficult cannulation of the common bile duct is encountered in about 10%of ERCP procedures. This frequently happens in the form of repeated unintentional cannulation of the pancreatic duct. Two valid options are available to facilitate cannulation at this point: Double guidewire technique or performing a transpancreatic precut. This is a randomized trial comparing the efficacy and Safety of double guidwire technique versus transpancreatic precut after three unintentional passages of the guidewire into the pancreatic duct.
Interventions
PROCEDUREDouble guidewire
After the 3rd passage of the guidewire into the pancreatic duct, the catheter will be removed leaving the guidewire in place. The catheter will be re-inserted and a second guidewire will be used and directed above the pancreatic wire in the 11-12 o'clock direction to attempt cannulation of the common bile duct.
PROCEDURETranspancreatic precut
After the 3rd passage of the guidewire unintentionally into the pancreatic duct, the guidewire will be left in the pancreatic duct, a sphincterotome will be used to cut in the direction of 11-12 o'clock attempting to deroof the pancreatic duct and gain access into the common bile duct. The wire will then be retracted and reinserted in the direction of the cut to attempt cannulation of the common bile duct.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* unintentional cannulation of the pancreatic duct 3 times * Consenting to join the study
Exclusion criteria
* Previous ERCP with or without previous sphincterotomy * Known coagulopathy * \- Pregnancy * \- Known acute pancreatitis at the time of procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cannulation success | Within 10 minutes | Proportion of patients with successful cannulation of the common bile duct |
| Rate of post-ERCP pancreatitis | up to 24 hours after the procedure | Proportion of patients suffering post-ERCP pancreatitis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to successful cannulation | Within 10 minutes | Time to achieve cannulation after the 3rd passage of the guidewire into the pancreatic duct |
Countries
Egypt
Contacts
Primary ContactHany Shehab
Outcome results
None listed