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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

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

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 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
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2020

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.




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.



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03118973


Contacts
Contact: Subhas Banerjee, MD 650-723-2623 sbanerje@stanford.edu

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Subhas Banerjee, MD       sbanerje@stanford.edu   
Principal Investigator: Subhas Banerjee, MD         
Sponsors and Collaborators
Subhas Banerjee

Responsible Party: Subhas Banerjee, Associate Professor of Medicine, Division of Gastroenterology, Stanford University
ClinicalTrials.gov Identifier: NCT03118973     History of Changes
Other Study ID Numbers: 38574
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: April 18, 2017
Last Verified: April 2017
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