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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

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
Subhas Banerjee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Biliary Obstruction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

First Posted
April 11, 2017
Last Updated
November 12, 2020
Sponsor
Subhas Banerjee
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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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