Common Bile Duct Gall StonesNCT01678391
Feasibility of Endoscopic Ultrasound Based Biliary Stone Removal Without Fluoroscopy
A study testing Common bile duct stone removal without fluoroscopy. in people with Common Bile Duct Gall Stones, run by California Pacific Medical Center Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Common Bile Duct Gall Stones
- What is being tested?
- Common bile duct stone removal without fluoroscopy.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients able to give informed consent
- Patients referred to IES for the endoscopic evaluation and treatment of suspected bile duct stones
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
California Pacific Medical Center
San Francisco, California, 94115
About this study
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.
- Conditions
- Common Bile Duct Gall Stones
- Being tested
- Common bile duct stone removal without fluoroscopy.
- Medical subject headings
- Gallstones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Common bile duct stone removal without fluoroscopy.Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with common bile duct stones. | Experimental | Common bile duct stone removal without fluoroscopy Receives: Procedure: Common bile duct stone removal without fluoroscopy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful removal of all stones from the bile duct without the use of fluoroscopy.
Measured: Up to 24 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2012 (estimated)
- Study startAug 2012
- Primary completionJun 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Common Bile Duct Gall StonesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- California Pacific Medical Center Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles, Northwestern University
- Responsible party
- Principal investigator, Janak Shah, MD, California Pacific Medical Center Research Institute
- Investigators
- Janak Shah, MD, Principal investigator, California Pacific Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01678391
- Sponsor's protocol ID
- 2012.065-1
- Status last verified
- Jul 2016
- First submitted
- 29 Aug 2012
- Last updated
- 26 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Carr-Locke DL. Overview of the role of ERCP in the management of diseases of the biliary tract and the pancreas. Gastrointest Endosc. 2002 Dec;56(6 Suppl):S157-60. doi: 10.1067/mge.2002.129023. No abstract available.
PubMed 12447259Shelton J, Linder JD, Rivera-Alsina ME, Tarnasky PR. Commitment, confirmation, and clearance: new techniques for nonradiation ERCP during pregnancy (with videos). Gastrointest Endosc. 2008 Feb;67(2):364-8. doi: 10.1016/j.gie.2007.09.036.
PubMed 18226705Menees S, Elta G. Endoscopic retrograde cholangiopancreatography during pregnancy. Gastrointest Endosc Clin N Am. 2006 Jan;16(1):41-57. doi: 10.1016/j.giec.2006.01.004.
PubMed 16546022Shah JN, Bhat YM, Hamerski CM, Kane SD, Binmoeller KF. Feasibility of nonradiation EUS-based ERCP in patients with uncomplicated choledocholithiasis (with video). Gastrointest Endosc. 2016 Nov;84(5):764-769. doi: 10.1016/j.gie.2016.03.1485. Epub 2016 Mar 31.
PubMed 27040099
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Endoscopic Ultrasound Based Biliary Stone Removal Without Fluoroscopy
- ClinicalTrials.gov ID
- NCT01678391
- Acronym / sponsor ID
- 2012.065-1
- Conditions
- Common Bile Duct Gall Stones
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- California Pacific Medical Center Research InstituteUniversity, hospital or other
- Collaborators
- University of California, Los Angeles, Northwestern University
- Study start
- Aug 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 5 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with common bile duct stones. | Experimental | Procedure: Common bile duct stone removal without fluoroscopy.Common bile duct stone removal without fluoroscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients able to give informed consent
- Patients referred to IES for the endoscopic evaluation and treatment of suspected bile duct stones
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Patients with common bile duct stones. |
Primary outcome
Successful removal of all stones from the bile duct without the use of fluoroscopy.
Time frame: Up to 24 hours.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2016.
- Background: PubMed 12447259Carr-Locke DL. Overview of the role of ERCP in the management of diseases of the biliary tract and the pancreas. Gastrointest Endosc. 2002 Dec;56(6 Suppl):S157-60. doi: 10.1067/mge.2002.129023. No abstract available.
- Background: PubMed 18226705Shelton J, Linder JD, Rivera-Alsina ME, Tarnasky PR. Commitment, confirmation, and clearance: new techniques for nonradiation ERCP during pregnancy (with videos). Gastrointest Endosc. 2008 Feb;67(2):364-8. doi: 10.1016/j.gie.2007.09.036.
- Background: PubMed 16546022Menees S, Elta G. Endoscopic retrograde cholangiopancreatography during pregnancy. Gastrointest Endosc Clin N Am. 2006 Jan;16(1):41-57. doi: 10.1016/j.giec.2006.01.004.
- Derived from this study: PubMed 27040099Shah JN, Bhat YM, Hamerski CM, Kane SD, Binmoeller KF. Feasibility of nonradiation EUS-based ERCP in patients with uncomplicated choledocholithiasis (with video). Gastrointest Endosc. 2016 Nov;84(5):764-769. doi: 10.1016/j.gie.2016.03.1485. Epub 2016 Mar 31.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janak Shah, MD principal investigator
California Pacific Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Common bile duct stone removal without fluoroscopy. in people with Common Bile Duct Gall Stones, run by California Pacific Medical Center Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful removal of all stones from the bile duct without the use of fluoroscopy. (time frame: Up to 24 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01678391, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2016.