Biliary Obstruction, Biliary Stones
Conditions
Brief summary
Randomized, prospective study evaluating efficacy and safety of Goff transpancreatic septotomy vs. double wire technique for achieving biliary access in patients who fail initial cannulation at ERCP.
Detailed description
Selective placement of a guidewire into the bile duct (biliary cannulation) during endoscopic retrograde cholangiopancreatography (ERCP) is necessary for performing therapeutic biliary procedures. The success rate for biliary cannulation by experienced endoscopists during ERCP is approximately 85% with standard cannulation techniques. Inadvertent placement of the guidewire into the pancreatic duct rather than the bile duct often occurs when attempting selective biliary cannulation in technically challenging cases. When this occurs repeatedly, other approaches may be used to facilitate selective biliary cannulation, but there are few prospective studies evaluating the efficacy and safety of these approaches. Here the investigators evaluate two approaches for technically challenging biliary cannulation: one involving maintenance of a wire in the pancreatic duct, followed by repeat attempt at biliary cannulation (double wire technique) and one involving a small incision in the septum adjacent to the pancreas followed by repeat attempt at biliary cannulation (transpancreatic septotomy). This study is a prospective randomized trial comparing the rate of cannulation success, procedure duration and complications following these two approaches.
Interventions
PROCEDUREGoff trans-pancreatic septotomy vs. Double wire technique
Goff trans-pancreatic septotomy vs. Double wire technique for achieving biliary access when biliary cannulation is challenging.
Sponsors
Subhas Banerjee
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients with challenging biliary cannulation randomized to either Goff trans-pancreatic septotomy or double wire technique to facilitate biliary cannulation.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 18 and older 2. Patient has a clinical indication for ERCP 3. Willing and able to comply with the study procedures and provide written informed consent to participate in the study.
Exclusion criteria
1. Age \<18 2. Potentially vulnerable subjects including, homeless people, pregnant females, employees and students. 3. Complex post-surgical anatomy e.g. Billroth type II anatomy, Roux-en-Y-gastrojejunostomy 4. Prior sphincterotomy or balloon dilation of ampulla 5. Thrombocytopenia, coagulopathy, or indication for ongoing anti-coagulation therapy 6. Participation in another investigational study that may directly or indirectly affect the results of this study within 30 days prior to the initial visit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful biliary cannulation assessed by fluoroscopic confirmation of biliary cannulation | Day of procedure | Successful biliary cannulation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse event rates assessed by 6-month follow-up of clinical and laboratory studies | 6 months | Rates of adverse events associated with the ERCP procedure following intervention to facilitate biliary cannulation. |
Countries
United States
Outcome results
None listed