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 : Completed
First Posted : September 5, 2012
Last Update Posted : February 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Disorders of Gallbladder Disorders of Biliary Tract||Procedure: EUS-Rendezvous or direct intervention Procedure: Advanced ERCP Biliary Access Techniques||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||226 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Endoscopic Ultrasound Guided Rendezvous or Direct Interventions Versus Advanced ERCP Techniques for Biliary Access and Therapy|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||December 2019|
|Actual Study Completion Date :||December 2019|
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
- 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?
- 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...
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01678326
|United States, California|
|California Pacific Medical Center|
|San Francisco, California, United States, 94115|
|Principal Investigator:||Christopher Hamerski, M.D.||California Pacific Medical Center|