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Feasibility of Endoscopic Ultrasound Based Biliary Stone Removal Without Fluoroscopy

Feasibility of Endoscopic Ultrasound Based Biliary Stone Removal Without Fluoroscopy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01678391
Enrollment
33
Registered
2012-09-05
Start date
2012-08-31
Completion date
2016-03-31
Last updated
2016-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Common Bile Duct Gall Stones

Brief summary

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.

Interventions

PROCEDURECommon bile duct stone removal without fluoroscopy.

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.

Sponsors

University of California, Los Angeles
CollaboratorOTHER
Northwestern University
CollaboratorOTHER
California Pacific Medical Center Research Institute
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Successful removal of all stones from the bile duct without the use of fluoroscopy.Up to 24 hours.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026