Evaluation of Efficacy and Safety of Goff Transpancreatic Septotomy vs. Double Wire Technique for Achieving Biliary Access in Technically Challenging ERCPs

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.

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