CholedocholithiasisNCT03074201
Prospective Evaluation of the Ability of Spyglass Cholangioscopy to Facilitate Radiation Free ERCP
A study testing Cholangioscopy and Spyglass DS Cholangioscope in people with Choledocholithiasis and Biliary Obstruction, run by Stanford University at 1 site in United States.
Trial summary
Prospective Evaluation of the Ability of Spyglass Cholangioscopy to Facilitate Radiation Free ERCP for non-complex bile duct stone disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Choledocholithiasis, Biliary Obstruction
- What is being tested?
- Cholangioscopy and Spyglass DS Cholangioscope
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2015to 20 May 2017
- 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
- Age 18 and above
- Non-complex biliary stone disease involving stones in the common bile or common hepatic duct.
- Patient has undergone non-invasive imaging (abdo US, MRCP etc) which clearly delineates bile duct diameter and suggests non complex biliary stone disease.
- Willing and able to comply with the study procedures and provide written informed consent to participate in the study.
Who cannot join
- Age <18
- Potentially vulnerable subjects including, homeless people, pregnant females, employees and students.
- Participation in another related investigational study that could affect the results of this study within the previous 30 days
- Complex biliary stone disease cases with unusual location of the stones (intra hepatic, cystic duct, stone proximal to bile duct stricture)
- Known bile duct infection (cholangitis defined as ongoing fevers on the day of the ERCP procedure or purulence evident at the ampulla or bile duct on cannulation/sphincterotomy. If clear bile is aspirated during the study procedure, we will proceed according to study procedures. If purulence is detected upon aspiration of bile during the procedure, patient will be excluded from the study and undergo standard radiation-based ERCP rather than cholangioscopy.)
- 5) Complex post-surgical anatomy e.g. Billroth type II anatomy, Roux-en-Y-gastrojejunostomy
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Prospective Evaluation of the Ability of Spyglass Cholangioscopy to Facilitate Radiation Free ERCP for non-complex bile duct stone disease.
- Conditions
- Choledocholithiasis, Biliary Obstruction
- Being tested
- Cholangioscopy, Spyglass DS Cholangioscope
- Keywords
- ERCP, choledocholithiasis, cholangioscopy
- Medical subject headings
- Choledocholithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholangioscopyProcedure or surgery
Cholangioscopy used instead of fluoroscopy-based ERCP to facilitate clearance of bile duct stones.
Spyglass DS CholangioscopeDevice
Cholangioscopy used instead of fluoroscopy-based ERCP to facilitate clearance of bile duct stones.
| Study group | Role | What they receive |
|---|---|---|
| Cholangioscopy | Experimental | Participants in this arm undergo radiation-free ERCP facilitated by cholangioscopy Receives: Procedure: Cholangioscopy; Device: Spyglass DS Cholangioscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone clearance
Successful clearance of stones from the bile duct using cholangioscopy
Measured: During the cholangioscopy procedure
Secondary outcomes (1)
Procedure Duration
Duration of procedure
Measured: 5 minutes to 2.5 hours anticipated time frame
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2017
- Study start1 Oct 2015
- Primary completion20 May 2017
- Study completion20 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CholedocholithiasisStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective feasibility study to evaluate potential for cholangioscopy to facilitate radiation-free ERCP.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Principal investigator, Subhas Banerjee, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03074201
- Sponsor's protocol ID
- 32194
- Status last verified
- Sep 2018
- First submitted
- 23 Feb 2017
- Last updated
- 11 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Barakat MT, Girotra M, Choudhary A, Huang RJ, Sethi S, Banerjee S. A prospective evaluation of radiation-free direct solitary cholangioscopy for the management of choledocholithiasis. Gastrointest Endosc. 2018 Feb;87(2):584-589.e1. doi: 10.1016/j.gie.2017.07.042. Epub 2017 Aug 7.
PubMed 28797911
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of the Ability of Spyglass Cholangioscopy to Facilitate Radiation Free ERCP
- ClinicalTrials.gov ID
- NCT03074201
- Acronym / sponsor ID
- 32194
- Conditions
- Choledocholithiasis, Biliary Obstruction
- Keywords
- ERCP, choledocholithiasis, cholangioscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 20 May 2017 (actual)
- Study completion
- 20 May 2017 (actual)
- First posted
- 8 Mar 2017 (actual)
- 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.
Prospective Evaluation of the Ability of Spyglass Cholangioscopy to Facilitate Radiation Free ERCP for non-complex bile duct stone disease.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective feasibility study to evaluate potential for cholangioscopy to facilitate radiation-free ERCP.
| Arm | Type | Receives |
|---|---|---|
| Cholangioscopy | Experimental | Procedure: Cholangioscopy, Device: Spyglass DS CholangioscopeParticipants in this arm undergo radiation-free ERCP facilitated by cholangioscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 and above
- Non-complex biliary stone disease involving stones in the common bile or common hepatic duct.
- Patient has undergone non-invasive imaging (abdo US, MRCP etc) which clearly delineates bile duct diameter and suggests non complex biliary stone disease.
- Willing and able to comply with the study procedures and provide written informed consent to participate in the study.
Key exclusion criteria (6 listed)
- Age <18
- Potentially vulnerable subjects including, homeless people, pregnant females, employees and students.
- Participation in another related investigational study that could affect the results of this study within the previous 30 days
- Complex biliary stone disease cases with unusual location of the stones (intra hepatic, cystic duct, stone proximal to bile duct stricture)
- Known bile duct infection (cholangitis defined as ongoing fevers on the day of the ERCP procedure or purulence evident at the ampulla or bile duct on cannulation/sphincterotomy. If clear bile is aspirated during the study procedure, we will proceed according to study procedures. If purulence is detected upon aspiration of bile during the procedure, patient will be excluded from the study and undergo standard radiation-based ERCP rather than cholangioscopy.)
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 |
|---|---|---|
| CholangioscopyCholangioscopy used instead of fluoroscopy-based ERCP to facilitate clearance of bile duct stones. | Procedure or surgery | Cholangioscopy |
| Spyglass DS CholangioscopeCholangioscopy used instead of fluoroscopy-based ERCP to facilitate clearance of bile duct stones. | Device | Cholangioscopy |
Primary outcome
Stone clearance
Time frame: During the cholangioscopy procedure
Successful clearance of stones from the bile duct using cholangioscopy
1 secondary outcome
Procedure Duration
Time frame: 5 minutes to 2.5 hours anticipated time frame
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 11 Sep 2018.
- Derived from this study: PubMed 28797911Barakat MT, Girotra M, Choudhary A, Huang RJ, Sethi S, Banerjee S. A prospective evaluation of radiation-free direct solitary cholangioscopy for the management of choledocholithiasis. Gastrointest Endosc. 2018 Feb;87(2):584-589.e1. doi: 10.1016/j.gie.2017.07.042. Epub 2017 Aug 7.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cholangioscopy and Spyglass DS Cholangioscope in people with Choledocholithiasis and Biliary Obstruction, run by Stanford University 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 4 inclusion and 6 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 11 Sep 2018. 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?
Stone clearance (time frame: During the cholangioscopy procedure). 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 NCT03074201, which also lists 1 linked publication.
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 11 Sep 2018.