EUS-Guided Rendezvous Versus Advanced ERCP Techniques for Biliary Access (RvA)
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.
Disorders of Gallbladder
Disorders of Biliary Tract
Procedure: Advanced ERCP Techniques
|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|
- 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.
- 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...
|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)|
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.
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.
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.
|Contact: Janak Shah, M.D.||415-600-1151|
|Contact: Steve Kanefirstname.lastname@example.org|
|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.|
|Principal Investigator:||Janak Shah, M.D.||California Pacific Medical Center|