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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by California Pacific Medical Center Research Institute
Sponsor:
Collaborators:
Northwestern University
University of Virginia
Information provided by (Responsible Party):
Janak Shah, MD, California Pacific Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT01678326
First received: August 29, 2012
Last updated: March 24, 2014
Last verified: March 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Endoscopic Ultrasound Guided Rendezvous or Direct Interventions Versus Advanced ERCP Techniques for Biliary Access and Therapy

Resource links provided by NLM:


Further study details as provided by 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 ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: Yes ]
    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: September 2016
Estimated Primary Completion Date: August 2016 (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

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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01678326

Contacts
Contact: Janak Shah, M.D. 415-600-1151
Contact: Steve Kane 415-600-1151 kanesd@sutterhealth.org

Locations
United States, California
California Pacific Medical Center Recruiting
San Francisco, California, United States, 94115
Contact: Janak Shah, M.D.    415-600-1151      
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
Investigators
Principal Investigator: Janak Shah, M.D. California Pacific Medical Center
  More Information

Publications:

Responsible Party: Janak Shah, 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
Study First Received: August 29, 2012
Last Updated: March 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by California Pacific Medical Center Research Institute:
Diseases Classified Elsewhere

Additional relevant MeSH terms:
Biliary Tract Diseases
Gallbladder Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 01, 2014