Feasibility of Endoscopic Ultrasound Based Biliary Stone Removal Without Fluoroscopy

To assess the feasibility and success of endoscopic ultrasound (EUS) directed biliary stone removal without use of fluoroscopy. Success for this study will be defined as the successful removal of all stones from the bile duct without the use of fluoroscopy. Fluoroscopy will only be used at the end of a presumed successful procedure to confirm that all stones are removed.

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Key information

Conditions

Common Bile Duct Gall Stones Biliary Tract Diseases Calculi Cholecystolithiasis Cholelithiasis Digestive System Diseases Gallbladder Diseases Gallstones Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

California Pacific Medical Center

San Francisco, California, 94115, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients able to give informed consent
Patients referred to IES for the endoscopic evaluation and treatment of suspected bile duct stones

Exclusion criteria

Patients with >3 bile duct stones or with any stone >12mm on EUS
Patients with no bile duct stones on EUS
Patients with altered biliary anatomy (periampullary diverticulum, anomalous pancreatibiliary junction, altered surgical anatomy)
Patients who are pregnant or breast-feeding

Treatment and study plan

Common bile duct stone removal without fluoroscopy.

Procedure

ERCP stone extraction technique without fluoroscopy involves: (1) catheter or catheter with wire access into the bile duct, (2) confirmation of biliary access with catheter aspiration of bile, (3) performance of endoscopic biliary sphincterotomy or balloon dilation to widen the bile duct opening to permit stone removal, (4) stone removal - number of stones seen on EUS should match the number removed.

Primary outcomes

Successful removal of all stones from the bile duct without the use of fluoroscopy.

Time frame: Up to 24 hours.

Sponsors and collaborators

Lead sponsor

California Pacific Medical Center Research Institute

Other

Collaborators

Northwestern University
University of California, Los Angeles

Registry information

Important dates

Study start: 2012
Primary completion: 2015
Study completion: 2016
First posted: Sep 5, 2012
Registry last updated: Jul 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed