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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Biliary Obstruction, Biliary Stones

Intervention / Treatment
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* Procedure: Goff trans-pancreatic septotomy vs. Double wire technique


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 and older Patient has a clinical indication for ERCP Willing and able to comply with the study procedures and provide written informed consent to participate in the study. Exclusion Criteria: Age <18 Potentially vulnerable subjects including, homeless people, pregnant females, employees and students. Complex post-surgical anatomy e.g. Billroth type II anatomy, Roux-en-Y-gastrojejunostomy Prior sphincterotomy or balloon dilation of ampulla Thrombocytopenia, coagulopathy, or indication for ongoing anti-coagulation therapy Participation in another investigational study that may directly or indirectly affect the results of this study within 30 days prior to the initial visit

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients with challenging biliary cannulation randomized to either Goff trans-pancreatic septotomy or double wire technique to facilitate biliary cannulation.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Goff<br>For patients in whom biliary cannulation is difficult to achieve, Goff trans-pancreatic septotomy will be performed to facilitate biliary cannulation. | Procedure: Goff trans-pancreatic septotomy vs. Double wire technique<br>* Goff trans-pancreatic septotomy vs. Double wire technique for achieving biliary access when biliary cannulation is challenging.<br>|
| Experimental: Double wire<br>For patients in whom biliary cannulation is difficult to achieve, double wire technique will be used to facilitate biliary cannulation. | Procedure: Goff trans-pancreatic septotomy vs. Double wire technique<br>* Goff trans-pancreatic septotomy vs. Double wire technique for achieving biliary access when biliary cannulation is challenging.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful biliary cannulation assessed by fluoroscopic confirmation of biliary cannulation | Successful biliary cannulation | Day of procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event rates assessed by 6-month follow-up of clinical and laboratory studies | Rates of adverse events associated with the ERCP procedure following intervention to facilitate biliary cannulation. | 6 months |