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

• ClinicalTrials.gov Identifier: NCT03118973
• Recruitment Status: Completed
• First Posted: April 18, 2017
• Last Update Posted: November 13, 2020
• Sponsor: Subhas Banerjee
• Information provided by (Responsible Party): Subhas Banerjee, Stanford University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Biliary Obstruction; Biliary Stones	Procedure: Goff trans-pancreatic septotomy vs. Double wire technique	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1600 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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)
• Primary Purpose: Treatment
• Official Title: Evaluation of Efficacy and Safety of Goff Transpancreatic Septotomy vs. Double Wire Technique for Achieving Biliary Access in Technically Challenging ERCPs
• Actual Study Start Date: September 27, 2016
• Actual Primary Completion Date: January 1, 2020
• Actual Study Completion Date: January 1, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Goff; 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; Goff trans-pancreatic septotomy vs. Double wire technique for achieving biliary access when biliary cannulation is challenging.
Experimental: Double wire; 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; Goff trans-pancreatic septotomy vs. Double wire technique for achieving biliary access when biliary cannulation is challenging.

Outcome Measures

Primary Outcome Measures :

1. Successful biliary cannulation assessed by fluoroscopic confirmation of biliary cannulation [ Time Frame: Day of procedure ]
   Successful biliary cannulation

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, California

Stanford University School of Medicine

Stanford, California, United States, 94305

Sponsors and Collaborators

Subhas Banerjee

More Information

• Responsible Party: Subhas Banerjee, Associate Professor of Medicine, Division of Gastroenterology, Stanford University
• ClinicalTrials.gov Identifier: NCT03118973
• Other Study ID Numbers: 38574
• First Posted: April 18, 2017
• Last Update Posted: November 13, 2020
• Last Verified: November 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Cholelithiasis; Cholecystolithiasis; Gallstones; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical