Evaluation of Efficacy and Safety of Goff Transpancreatic Septotomy vs. Double Wire Technique for Achieving Biliary Access in Technically Challenging ERCPs
Primary Purpose
Biliary Obstruction, Biliary Stones
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Goff trans-pancreatic septotomy vs. Double wire technique
Sponsored by
About this trial
This is an interventional treatment trial for Biliary Obstruction
Eligibility Criteria
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
Sites / Locations
- Stanford University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Goff
Double wire
Arm Description
For patients in whom biliary cannulation is difficult to achieve, Goff trans-pancreatic septotomy will be performed to facilitate biliary cannulation.
For patients in whom biliary cannulation is difficult to achieve, double wire technique will be used to facilitate biliary cannulation.
Outcomes
Primary Outcome Measures
Successful biliary cannulation assessed by fluoroscopic confirmation of biliary cannulation
Successful biliary cannulation
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03118973
Brief Title
Evaluation of Efficacy and Safety of Goff Transpancreatic Septotomy vs. Double Wire Technique for Achieving Biliary Access in Technically Challenging ERCPs
Official Title
Evaluation of Efficacy and Safety of Goff Transpancreatic Septotomy vs. Double Wire Technique for Achieving Biliary Access in Technically Challenging ERCPs
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
September 27, 2016 (Actual)
Primary Completion Date
January 1, 2020 (Actual)
Study Completion Date
January 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Subhas Banerjee
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Obstruction, Biliary Stones
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
1600 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Goff
Arm Type
Experimental
Arm Description
For patients in whom biliary cannulation is difficult to achieve, Goff trans-pancreatic septotomy will be performed to facilitate biliary cannulation.
Arm Title
Double wire
Arm Type
Experimental
Arm Description
For patients in whom biliary cannulation is difficult to achieve, double wire technique will be used to facilitate biliary cannulation.
Intervention Type
Procedure
Intervention Name(s)
Goff trans-pancreatic septotomy vs. Double wire technique
Intervention Description
Goff trans-pancreatic septotomy vs. Double wire technique for achieving biliary access when biliary cannulation is challenging.
Primary Outcome Measure Information:
Title
Successful biliary cannulation assessed by fluoroscopic confirmation of biliary cannulation
Description
Successful biliary cannulation
Time Frame
Day of procedure
Secondary Outcome Measure Information:
Title
Adverse event rates assessed by 6-month follow-up of clinical and laboratory studies
Description
Rates of adverse events associated with the ERCP procedure following intervention to facilitate biliary cannulation.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of Efficacy and Safety of Goff Transpancreatic Septotomy vs. Double Wire Technique for Achieving Biliary Access in Technically Challenging ERCPs
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