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

February 6, 2020 updated by: Christopher Hemerski, California Pacific Medical Center Research Institute

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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:

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.

Study Type

Interventional

Enrollment (Actual)

226

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94115
        • California Pacific Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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?
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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...
Up to 1 month post procedure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

California Pacific Medical Center Research Institute

Collaborators

University of California, Los Angeles
Northwestern University
University of Virginia

Investigators

  • Principal Investigator: Christopher Hamerski, M.D., California Pacific Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

August 29, 2012

First Submitted That Met QC Criteria

September 4, 2012

First Posted (Estimate)

September 5, 2012

Study Record Updates

Last Update Posted (Actual)

February 7, 2020

Last Update Submitted That Met QC Criteria

February 6, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012.061-2-JSha

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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