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

Primary Purpose

Disorders of Gallbladder, Disorders of Biliary Tract

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EUS-Rendezvous or direct intervention
Advanced ERCP Biliary Access Techniques
Sponsored by
California Pacific Medical Center Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Disorders of Gallbladder focused on measuring Diseases Classified Elsewhere

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • California Pacific Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

EUS-Rendezvous or direct intervention

Advanced ERCP Biliary Access Techniques

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Biliary access for therapy achieved (wire access across papilla or site of obstruction or wire access to enable successful therapy)
Was the endoscopist able to achieve wire access into the biliary system in order to complete the intended therapy? Was intended therapy successful?

Secondary Outcome Measures

Comparison of adverse events in the two arms.
Was there a difference in adverse events in the two arms. Adverse events include acute pancreatitis, hematoma, bile leak, etc...

Full Information

First Posted
August 29, 2012
Last Updated
February 6, 2020
Sponsor
California Pacific Medical Center Research Institute
Collaborators
Northwestern University, University of Virginia, University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT01678326
Brief Title
EUS-Guided Rendezvous or Direct Interventions Versus Advanced ERCP Techniques for Biliary Access and Therapy
Official Title
Endoscopic Ultrasound Guided Rendezvous or Direct Interventions Versus Advanced ERCP Techniques for Biliary Access and Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
December 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
California Pacific Medical Center Research Institute
Collaborators
Northwestern University, University of Virginia, University of California, Los Angeles

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disorders of Gallbladder, Disorders of Biliary Tract
Keywords
Diseases Classified Elsewhere

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
226 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EUS-Rendezvous or direct intervention
Arm Type
Active Comparator
Arm Description
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
Arm Title
Advanced ERCP Biliary Access Techniques
Arm Type
Active Comparator
Arm Description
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 Type
Procedure
Intervention Name(s)
EUS-Rendezvous or direct intervention
Intervention Type
Procedure
Intervention Name(s)
Advanced ERCP Biliary Access Techniques
Primary Outcome Measure Information:
Title
Biliary access for therapy achieved (wire access across papilla or site of obstruction or wire access to enable successful therapy)
Description
Was the endoscopist able to achieve wire access into the biliary system in order to complete the intended therapy? Was intended therapy successful?
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Comparison of adverse events in the two arms.
Description
Was there a difference in adverse events in the two arms. Adverse events include acute pancreatitis, hematoma, bile leak, etc...
Time Frame
Up to 1 month post procedure.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Hamerski, M.D.
Organizational Affiliation
California Pacific Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
California Pacific Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
12447259
Citation
Carr-Locke DL. Overview of the role of ERCP in the management of diseases of the biliary tract and the pancreas. Gastrointest Endosc. 2002 Dec;56(6 Suppl):S157-60. doi: 10.1067/mge.2002.129023. No abstract available.
Results Reference
background
PubMed Identifier
22018554
Citation
Shah JN, Marson F, Weilert F, Bhat YM, Nguyen-Tang T, Shaw RE, Binmoeller KF. Single-operator, single-session EUS-guided anterograde cholangiopancreatography in failed ERCP or inaccessible papilla. Gastrointest Endosc. 2012 Jan;75(1):56-64. doi: 10.1016/j.gie.2011.08.032. Epub 2011 Oct 21.
Results Reference
background
PubMed Identifier
9378207
Citation
Johnson GK, Geenen JE, Johanson JF, Sherman S, Hogan WJ, Cass O. Evaluation of post-ERCP pancreatitis: potential causes noted during controlled study of differing contrast media. Midwest Pancreaticobiliary Study Group. Gastrointest Endosc. 1997 Sep;46(3):217-22. doi: 10.1016/s0016-5107(97)70089-0.
Results Reference
background
PubMed Identifier
8782497
Citation
Freeman ML, Nelson DB, Sherman S, Haber GB, Herman ME, Dorsher PJ, Moore JP, Fennerty MB, Ryan ME, Shaw MJ, Lande JD, Pheley AM. Complications of endoscopic biliary sphincterotomy. N Engl J Med. 1996 Sep 26;335(13):909-18. doi: 10.1056/NEJM199609263351301.
Results Reference
background
PubMed Identifier
21916994
Citation
Angsuwatcharakon P, Rerknimitr R, Ridtitid W, Ponauthai Y, Kullavanijaya P. Success rate and cannulation time between precut sphincterotomy and double-guidewire technique in truly difficult biliary cannulation. J Gastroenterol Hepatol. 2012 Feb;27(2):356-61. doi: 10.1111/j.1440-1746.2011.06927.x.
Results Reference
background
PubMed Identifier
11232684
Citation
Masci E, Toti G, Mariani A, Curioni S, Lomazzi A, Dinelli M, Minoli G, Crosta C, Comin U, Fertitta A, Prada A, Passoni GR, Testoni PA. Complications of diagnostic and therapeutic ERCP: a prospective multicenter study. Am J Gastroenterol. 2001 Feb;96(2):417-23. doi: 10.1111/j.1572-0241.2001.03594.x.
Results Reference
background
PubMed Identifier
19098846
Citation
Wang P, Li ZS, Liu F, Ren X, Lu NH, Fan ZN, Huang Q, Zhang X, He LP, Sun WS, Zhao Q, Shi RH, Tian ZB, Li YQ, Li W, Zhi FC. Risk factors for ERCP-related complications: a prospective multicenter study. Am J Gastroenterol. 2009 Jan;104(1):31-40. doi: 10.1038/ajg.2008.5.
Results Reference
background
PubMed Identifier
22248603
Citation
Dhir V, Bhandari S, Bapat M, Maydeo A. Comparison of EUS-guided rendezvous and precut papillotomy techniques for biliary access (with videos). Gastrointest Endosc. 2012 Feb;75(2):354-9. doi: 10.1016/j.gie.2011.07.075.
Results Reference
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EUS-Guided Rendezvous or Direct Interventions Versus Advanced ERCP Techniques for Biliary Access and Therapy

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