Feasibility of Endoscopic Ultrasound Based Biliary Stone Removal Without Fluoroscopy
This study is currently recruiting participants.
Verified October 2012 by California Pacific Medical Center Research Institute
Sponsor:
California Pacific Medical Center Research Institute
Collaborators:
University of California, Los Angeles
Northwestern University
Information provided by (Responsible Party):
Janak Shah, MD, California Pacific Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT01678391
First received: August 29, 2012
Last updated: October 17, 2012
Last verified: October 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Common Bile Duct Calculi |
Procedure: Common bile duct stone removal without fluoroscopy. |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
Resource links provided by NLM:
Further study details as provided by California Pacific Medical Center Research Institute:
Primary Outcome Measures:
- Successful removal of all stones from the bile duct without the use of fluoroscopy. [ Time Frame: Up to 24 hours. ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | August 2012 |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Patients with common bile duct stones. |
Procedure: Common 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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients with common bile duct stones.
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01678391
Contacts
| Contact: Janak Shah, M.D. | 415-600-1151 | |
| Contact: Steve Kane | 415-600-1151 | kanesd@sutterhealth.org |
Locations
| United States, California | |
| California Pacific Medical Center | Recruiting |
| San Francisco, California, United States, 94115 | |
| Contact: Janak Shah, M.D. 415-600-1151 | |
| Contact: Steve Kane 415-600-1151 | |
| Principal Investigator: Janak Shah, M.D. | |
| Sub-Investigator: Kenneth Binmoeller, M.D. | |
| Sub-Investigator: Yasser Bhat, M.D. | |
Sponsors and Collaborators
California Pacific Medical Center Research Institute
University of California, Los Angeles
Northwestern University
More Information
Publications:
| Responsible Party: | Janak Shah, MD, Director of Pancreatic and Biliary Endoscopy, California Pacific Medical Center Research Institute |
| ClinicalTrials.gov Identifier: | NCT01678391 History of Changes |
| Other Study ID Numbers: | 2012.065-1 |
| Study First Received: | August 29, 2012 |
| Last Updated: | October 17, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Calculi Gallstones Pathological Conditions, Anatomical Cholelithiasis |
Biliary Tract Diseases Digestive System Diseases Cholecystolithiasis Gallbladder Diseases |
ClinicalTrials.gov processed this record on May 21, 2013