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EUS-Guided Rendezvous Versus Advanced ERCP Techniques for Biliary Access (RvA)

This study is currently recruiting participants.
Verified October 2012 by California Pacific Medical Center Research Institute
Sponsor:
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: October 17, 2012
Last verified: October 2012
History of Changes
  Purpose

The purpose of this study is to prospectively compare the safety and efficacy of endoscopic ultrasound-guided rendezvous access of the bile duct to that of advanced ERCP cannulation techniques in the setting of difficult cannulation. We hypothesize that EUS-guided rendezvous will be more successful and may be associated with the same (or less) complications than using advanced ERCP techniques in cases of difficult bile duct access.


Condition Intervention
Disorders of Gallbladder
Disorders of Biliary Tract
 Procedure: EUS-Rendezvous
Procedure: Advanced ERCP Techniques

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Endoscopic Ultrasound Guided Rendezvous Versus Advanced ERCP Techniques for Biliary Access

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by California Pacific Medical Center Research Institute:

Primary Outcome Measures:
  • Biliary access achieved. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Was the endoscopist able to access the bile duct with the given technique.


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: 164
Study Start Date: July 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: EUS-Rendezvous
EUS rendezvous involves 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. This wire can then be retrieved endoscopically ("rendezvous") to complete the ERCP.
 Procedure: EUS-Rendezvous
EUS is used to access the bile duct with a small needle and manipulate a wire across the biliary orifice and into the duodenum. This wire is then retrieved endoscopically ("rendezvous") to complete the ERCP.
Active Comparator: Advanced ERCP Techniques
Advanced ERCP techniques involve any of the following: precut access sphincterotomy, needle-knife fistulotomy, double guidewire, and/or double catheter techniques. All of these are accepted techniques for biliary access in cases of difficult cannulation.
 Procedure: Advanced ERCP Techniques
Advanced ERCP techniques include any of the following: precut access sphincterotomy, needle-knife fistulotomy, double guidewire, and/or double catheter techniques.

Detailed Description:

Biliary tract obstruction from stones or strictures are usually treated using endoscopic retrograde cholangiopancreatography (ERCP) techniques. However, biliary access (cannulation) during ERCP can be difficult. Overall cannulation success is about 90-95% at expert, centers. Difficult cannulation is associated with increased complication rates, as prolonged and repeated attempts can cause injury to the ampulla. When standard biliary cannulation fails advanced cannulation techniques, such as precut access sphincterotomy, are often indicated. These advanced techniques, however, increase the complication rate of ERCP, and still fail in a certain percentage of cases.

Endoscopic ultrasound (EUS)-guided rendezvous is a relatively newer technique that has emerged as a useful option to achieve biliary access when standard and advanced ERCP techniques for biliary access have failed. Many centers, including ours, are currently using EUS-guided rendezvous to facilitate ERCP access, when needed. EUS rendezvous is considered a safe and highly effective procedure for gaining access to the biliary tree. The physicians at Interventional Endoscopy Services have recently published their retrospective experience with EUS rendezvous for biliary access after failed ERCP cannulation, and reported a success rate of 75%. In addition, a recent retrospective study comparing the safety and efficacy of EUS rendezvous to precut sphincterotomy (advanced ERCP technique for access), found that EUS-rendezvous was significantly more successful with no significant difference in the rate of procedural complications.

Currently, there are no accepted standards for deciding which biliary access technique to use in cases of difficult biliary cannulation. We hypothesize that EUS-guided rendezvous will be more successful and may be associated with the same (or less) complications than using advanced ERCP techniques in cases of difficult bile duct access.

  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 IES for ERCP with the intent to cannulate the bile duct

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 within 10 minutes
  • Patients with prior biliary sphincterotomy or endoscopic papilla dilation
  • Patients with previous surgical biliary-intestinal operations
  • Patients with pancreas divisum
  • Patients with pancreatic or biliary stent placement within 6 months time
  • Patients who are pregnant or breast-feeding
  Contacts and Locations
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
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: October 17, 2012
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 June 18, 2013