CholedocholithiasisNCT01475864
Prospective Evaluation of the Covered Self-expandable Metal Stents (CSEMS) for Incomplete Biliary Stone Clearance
An observational study of Choledocholithiasis, run by University of Florida.
Trial summary
The current standard of care for bile duct stone are endoscopic sphincterotomy and stone extraction. Placement of plastic stents is an option for incomplete biliary stone clearance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Choledocholithiasis
- What is being tested?
- ERCP with metal stent
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2011to Jun 2013
- Phase
- Observational
- 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
Study population: Those patients who have a biliary stone that has not been removed by standard medical care.
Who may be able to join
- 18 years and older
- Bilary stone unable to be extracted with balloon, basket, large balloon dilation of the ampulla or mechanical lithotripsy.
- Stone can be bridged by the metal stent
- Subject must be able to give informed consent.
Who cannot join
- Any contraindication to ERCP
- Patient refuses consent for the study.
About this study
Official title: Prospective Evaluation of the Clinical Utility of Endoscopically-placed Self Expandable Stents
The current standard of care for bile duct stone are endoscopic sphincterotomy and stone extraction. Placement of plastic stents is an option for incomplete biliary stone clearance. This study will use the CSEMS in patients with complex biliary stones who failed stone extraction as they have the advantage of large stent diameter. CSEMS may offer a temporizing measure that allows more successful subsequent stone clearance. However, their use in benign condition has been limited especially for biliary stone removal. The purpose of this study is to determine the feasibility, safety, easy removability, stent-stone formation rate, and migration rate of CSEMS for complex biliary stones.
Read the detailed description
same as brief summary
- Conditions
- Choledocholithiasis
- Being tested
- ERCP with metal stent
- Keywords
- Choledocholithiasis, metal stents, biliary duct stent
- Medical subject headings
- Choledocholithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERCP with metal stentProcedure or surgery
Also called see above information
ERCP will be used so that a metal stent can be placed to facilitate the removal of the biliary stone
| Study group | Role | What they receive |
|---|---|---|
| Incomplete biliary stone extraction. | Not described Receives: Procedure: ERCP with metal stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete biliary stone clearance
This is an observational study where the ERCP being done is part of the standard of care for choledocholithiasis. There are no study interventions
Measured: 12 months
Secondary outcomes (1)
other techniques used for stone clearance
This will include the number of ERCP's needed to achive the complete biliary stone clearance, Use of mechanical Lithotripsy, use of cholangioscopy, procedure duration and any adverse events safety
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionJun 2013
- Study completionJun 2013
Why it stopped: no subjects were found who met criteria
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholedocholithiasisStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter V Draganov, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01475864
- Sponsor's protocol ID
- Biliary stone
- Status last verified
- Jun 2013
- First submitted
- 16 Nov 2011
- Last updated
- 27 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of the Clinical Utility of Endoscopically-placed Self Expandable Stents
- ClinicalTrials.gov ID
- NCT01475864
- Acronym / sponsor ID
- Biliary stone
- Conditions
- Choledocholithiasis
- Keywords
- Choledocholithiasis, metal stents, biliary duct stent
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: no subjects were found who met criteria
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 21 Nov 2011 (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.
The current standard of care for bile duct stone are endoscopic sphincterotomy and stone extraction. Placement of plastic stents is an option for incomplete biliary stone clearance. This study will use the CSEMS in patients with complex biliary stones who failed stone extraction as they have the advantage of large stent diameter. CSEMS may offer a temporizing measure that allows more successful subsequent stone clearance. However, their use in benign condition has been limited especially for biliary stone removal. The purpose of this study is to determine the feasibility, safety, easy removability, stent-stone formation rate, and migration rate of CSEMS for complex biliary stones.
Detailed description
same as brief summary
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Incomplete biliary stone extraction. | – | Procedure: ERCP with metal stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Those patients who have a biliary stone that has not been removed by standard medical care.
Key inclusion criteria (4 listed)
- 18 years and older
- Bilary stone unable to be extracted with balloon, basket, large balloon dilation of the ampulla or mechanical lithotripsy.
- Stone can be bridged by the metal stent
- Subject must be able to give informed consent.
Key exclusion criteria (2 listed)
- Any contraindication to ERCP
- Patient refuses consent for the study.
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 |
|---|---|---|
| ERCP with metal stentAlso: see above informationERCP will be used so that a metal stent can be placed to facilitate the removal of the biliary stone | Procedure or surgery | Incomplete biliary stone extraction. |
Primary outcome
complete biliary stone clearance
Time frame: 12 months
This is an observational study where the ERCP being done is part of the standard of care for choledocholithiasis. There are no study interventions
1 secondary outcome
other techniques used for stone clearance
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2013.
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ChOlecystectomy aFter successFul Endoscopic Common Bile Duct Stone Extraction in Elderly
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EUS-Guided Gallbladder Drainage Versus Conservative Management in Patients Unfit for Surgery After a Biliary Event Without Cholecystitis. DRECON Study
Cholecystectomy, Gallbladder
RecruitingObservational study
Treatment Outcomes and Complications of Three Therapeutic Approaches for Concomitant Choledocholithiasis and Cholecystolithiasis
Cholelithiasis Associated With Common Bile Duct Stones
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.
Peter V Draganov, MD principal investigator
University of Florida
Questions about this trial
What is this clinical trial studying?
An observational study of Choledocholithiasis, run by University of Florida.
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 2 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: withdrawn, as of the sponsor's last update on 27 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
complete biliary stone clearance (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jun 2013.