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

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ClinicalTrials.gov Identifier: NCT01678326
Recruitment Status : Recruiting
First Posted : September 5, 2012
Last Update Posted : February 24, 2017
Sponsor:
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

August 29, 2012
September 5, 2012
February 24, 2017
August 2012
December 2017   (Final data collection date for primary outcome measure)
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?
Biliary access achieved. [ Time Frame: 24 hours ]
Was the endoscopist able to access the bile duct with the given technique.
Complete list of historical versions of study NCT01678326 on ClinicalTrials.gov Archive Site
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...
Same as current
Not Provided
Not Provided
 
EUS-Guided Rendezvous or Direct Interventions Versus Advanced ERCP Techniques for Biliary Access and Therapy
Endoscopic Ultrasound Guided Rendezvous or Direct Interventions Versus Advanced ERCP Techniques for Biliary Access and Therapy
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.

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:

Patients referred for ERCP for biliary interventions at participating centers will be approached for consent. Patients who agree to participate will undergo a standard ERCP. The attending endoscopist will use standard ERCP techniques (i.e. cannulation with a standard cannula or sphincterotome with or without a wire) to gain biliary access for a minimum of ten minutes. If biliary access fails, the patient will be randomized to either the EUS-guided intervention arm or the advanced cannulation techniques arm of the study. The randomization ratio will be 50-50.

Methods of Data Analysis:

Based on current available data as well as our own experience, we estimated the success for immediate biliary access for EUS-guided intervention to be 90%, and for advanced ERCP cannulation techniques to be 75%. To detect this difference with power of 0.8 and a p-value of <0.05, a sample size of approximately 230 patients will be needed. Assuming that only 10% of patients that are consented will be randomized (based on the rationale that 90% of patients will either be successfully cannulated within 10 or will be excluded for other reasons) we estimate that approximately 2,300 patients will be consented for this study.

As this is the first study of its kind and it is possible that we will achieve statistical significance at an enrollment number earlier than our anticipated number of 230 participants two interim analyses are planned for this study. The first interim analysis is scheduled to occur after the enrollment of 70 patients (35 in each arm) and the second after enrollment of 140 patients (70 in each arm). The block randomization should result in equal numbers of patients in each arm at these enrollment levels. Adjustment for significance level at each interim analysis was calculated using the Pocock Boundary method (9). For either of the interim analyses, the level of significance required for termination of the trial for efficacy is p = 0.0221. An independent statistician will review the results and make recommendations regarding study termination based on results of interim analyses.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Disorders of Gallbladder
  • Disorders of Biliary Tract
  • Procedure: EUS-Rendezvous or direct intervention
  • Procedure: Advanced ERCP Biliary Access Techniques
  • 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
    Intervention: 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.
    Intervention: Procedure: Advanced ERCP Biliary Access Techniques

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
230
164
July 2018
December 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Janak Shah, M.D. 415-600-1151
Contact: Jona Calitis 415-600-1151
United States
 
 
NCT01678326
2012.061-2-JSha
No
Not Provided
Not Provided
Yasser Bhat, MD, California Pacific Medical Center Research Institute
California Pacific Medical Center Research Institute
  • Northwestern University
  • University of Virginia
  • University of California, Los Angeles
Principal Investigator: Janak Shah, M.D. California Pacific Medical Center
California Pacific Medical Center Research Institute
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP