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
| Tracking Information | |||||||||
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| First Received Date ICMJE | August 29, 2012 | ||||||||
| Last Updated Date | October 17, 2012 | ||||||||
| Start Date ICMJE | August 2012 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01678391 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Feasibility of Endoscopic Ultrasound Based Biliary Stone Removal Without Fluoroscopy | ||||||||
| Official Title ICMJE | Not Provided | ||||||||
| 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Patients with common bile duct stones. |
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| Condition ICMJE | Common Bile Duct Calculi | ||||||||
| Intervention ICMJE | 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. |
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| Study Group/Cohort (s) | Patients with common bile duct stones.
Intervention: Procedure: Common bile duct stone removal without fluoroscopy. |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 50 | ||||||||
| Completion Date | Not Provided | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01678391 | ||||||||
| Other Study ID Numbers ICMJE | 2012.065-1 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Janak Shah, MD, California Pacific Medical Center Research Institute | ||||||||
| Study Sponsor ICMJE | California Pacific Medical Center Research Institute | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE | Not Provided | ||||||||
| Information Provided By | California Pacific Medical Center Research Institute | ||||||||
| Verification Date | October 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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