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

Not Applicable

Completed

• Conditions: Biliary Stones; Biliary Obstruction
• Interventions: Procedure: Goff trans-pancreatic septotomy vs. Double wire technique

• Registration Number: NCT03118973
• Lead Sponsor: Subhas Banerjee

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.

Study Timeline

• Study Start: 2016-09-27
• Study First Submitted: 2017-04-11
• Study First Submitted QC: 2017-04-13
• Study First Posted: 2017-04-18
• Primary Completion: 2020-01-01
• Study Completion: 2020-01-01
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-12
• Last Update Posted: 2020-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1600

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Goff	Goff trans-pancreatic septotomy vs. Double wire technique	For patients in whom biliary cannulation is difficult to achieve, Goff trans-pancreatic septotomy will be performed to facilitate biliary cannulation.
Double wire	Goff trans-pancreatic septotomy vs. Double wire technique	For patients in whom biliary cannulation is difficult to achieve, double wire technique will be used to facilitate biliary cannulation.

Primary Outcome Measures

Name	Time	Method
Successful biliary cannulation assessed by fluoroscopic confirmation of biliary cannulation	Day of procedure	Successful biliary cannulation

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States