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

Completed · Not applicable

Conditions studied: Disorders of Gallbladder, Disorders of Biliary Tract

In brief

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.

Key facts

Study ID

NCT01678326

Run by

California Pacific Medical Center Research Institute

People needed

226

Starts

2012-08-01

Expected to finish

2019-12-01

Last updated by the study team

2020-02-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients able to give informed consent
• Patients referred to participating centers for ERCP with the intent to cannulate the bile duct for therapy

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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