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EUS-Guided Rendezvous or Direct Interventions Versus Advanced ERCP Techniques for Biliary Access and Therapy

This study is currently recruiting participants.
Verified February 2017 by Yasser Bhat, MD, California Pacific Medical Center Research Institute
Sponsor:
ClinicalTrials.gov Identifier:
NCT01678326
First Posted: September 5, 2012
Last Update Posted: February 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Northwestern University
University of Virginia
University of California, Los Angeles
Information provided by (Responsible Party):
Yasser Bhat, MD, California Pacific Medical Center Research Institute
  Purpose
The purpose of this study is to prospectively compare the efficacy of endoscopic ultrasound-guided biliary interventions (EUS-rendezvous or direct EUS-guided therapy) to that of advanced ERCP cannulation techniques in the setting of difficult cannulation. We hypothesize that EUS-guided interventions will be more successful and may be associated with the same complications as using advanced ERCP techniques in cases of difficult bile duct access.

Condition Intervention
Disorders of Gallbladder Disorders of Biliary Tract Procedure: EUS-Rendezvous or direct intervention Procedure: Advanced ERCP Biliary Access Techniques

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Endoscopic Ultrasound Guided Rendezvous or Direct Interventions Versus Advanced ERCP Techniques for Biliary Access and Therapy

Further study details as provided by Yasser Bhat, MD, California Pacific Medical Center Research Institute:

Primary Outcome Measures:
  • Biliary access for therapy achieved (wire access across papilla or site of obstruction or wire access to enable successful therapy) [ Time Frame: 24 hours ]
    Was the endoscopist able to achieve wire access into the biliary system in order to complete the intended therapy? Was intended therapy successful?


Secondary Outcome Measures:
  • Comparison of adverse events in the two arms. [ Time Frame: Up to 1 month post procedure. ]
    Was there a difference in adverse events in the two arms. Adverse events include acute pancreatitis, hematoma, bile leak, etc...


Estimated Enrollment: 230
Study Start Date: August 2012
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: EUS-Rendezvous or direct intervention
EUS rendezvous or direct intervention involves: (1) using endoscopic-ultrasound technology to access the bile duct with a small needle and manipulate a wire across the biliary orifice and into the duodenum to be then retrieved endoscopically for ERCP (rendezvous ERCP), or (2) using endoscopic-ultrasound technology to directly puncture and perform intended biliary therapy
Procedure: EUS-Rendezvous or direct intervention
Active Comparator: Advanced ERCP Biliary Access Techniques
Advanced ERCP techniques involve the following: precut access sphincterotomy and needle-knife fistulotomy. These are accepted techniques for biliary access in cases of difficult cannulation.
Procedure: Advanced ERCP Biliary Access Techniques

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Patients able to give informed consent
  • Patients referred to participating centers for ERCP with the intent to cannulate the bile duct for therapy

Exclusion Criteria:

  • Patients with a bleeding diathesis (INR >1.4, platelets <80, current use of anticoagulant medications)
  • Patients whose bile ducts are cannulated using standard methods
  • Patients with prior biliary sphincterotomy or endoscopic papilla dilation
  • Patients with previous surgical biliary-intestinal operations
  • Patients with pancreas divisum
  • Patients with indwelling pancreatic or biliary stent placement
  • Patients who are pregnant or breast-feeding
  Contacts and Locations
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): NCT01678326


Contacts
Contact: Janak Shah, M.D. 415-600-1151
Contact: Jona Calitis 415-600-1151

Locations
United States, California
California Pacific Medical Center Recruiting
San Francisco, California, United States, 94115
Contact: Janak Shah, M.D.    415-600-1151      
Contact: Jona Calitis       CalitiJ@sutterhealth.org   
Principal Investigator: Janak Shah, M.D.         
Sub-Investigator: Kenneth Binmoeller, M.D.         
Sub-Investigator: Yasser Bhat, M.D.         
Sponsors and Collaborators
California Pacific Medical Center Research Institute
Northwestern University
University of Virginia
University of California, Los Angeles
Investigators
Principal Investigator: Janak Shah, M.D. California Pacific Medical Center
  More Information

Publications:

Responsible Party: Yasser Bhat, MD, Director of Pancreatic and Biliary Endoscopy, California Pacific Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT01678326     History of Changes
Other Study ID Numbers: 2012.061-2-JSha
First Submitted: August 29, 2012
First Posted: September 5, 2012
Last Update Posted: February 24, 2017
Last Verified: February 2017

Keywords provided by Yasser Bhat, MD, California Pacific Medical Center Research Institute:
Diseases Classified Elsewhere

Additional relevant MeSH terms:
Disease
Gallbladder Diseases
Biliary Tract Diseases
Pathologic Processes
Digestive System Diseases