Endoscopic Ultrasound Guided Rendezvous or Direct Interventions Versus Advanced ERCP Techniques for Biliary Access and Therapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 226
- Locations
- 1
- Primary Endpoint
- Biliary access for therapy achieved (wire access across papilla or site of obstruction or wire access to enable successful therapy)
Study Overview
Brief Summary
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.
Detailed Description
Background:
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-guided biliary interventions are relatively newer techniques that have emerged as a useful option to achieve biliary access or therapy when standard and advanced ERCP techniques for biliary access have failed. Many centers, including ours, are currently using EUS-guided interventions to facilitate ERCP access and therapy, when needed. EUS-guided interventions have emerged as a safe and effective procedure for gaining access to the biliary tree. 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 biliary interventions 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.
Procedures:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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
Intervention: EUS-Rendezvous or direct intervention (Procedure)
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.
Intervention: Advanced ERCP Biliary Access Techniques (Procedure)
Outcomes
Primary Outcomes
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 Outcomes
- Comparison of adverse events in the two arms.(Up to 1 month post procedure.)
Investigators
Christopher Hemerski
Director of Luminal Oncology
California Pacific Medical Center Research Institute