Biliary StrictureERCPNCT00894348
Factors Predicting Positive Yields on Biliary Brush Cytology During Endoscopic Retrograde Cholangiopancreatography
An observational study of Biliary Stricture, run by The Cleveland Clinic at 1 site in United States.
Trial summary
To determine factors associated with a positive yield of malignancy on biliary brush cytology obtained by ERCP. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Biliary Stricture
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing an ERCP for evaluation of biliary strictures
Who may be able to join
- ERCP Patients
Who cannot join
- Non ERCP Patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EXEMPT: Prospective Factors Predicting Positive Yields on Biliary Brush Cytology During Endoscopic Retrograde Cholangio-pancreatography (ERCP)
To determine factors associated with a positive yield of malignancy on biliary brush cytology obtained by ERCP.
Read the detailed description
There are only 3 studies available that have tried to evaluate factors influencing the yield of brush cytology. Two of the 3 studied one parameter. The third study, which is also the largest, reported on 199 samples which the authors evaluated in a retrospect fashion. We plan to conduct a larger study assessing several other factors that have not been studied before. The study findings would help develop strategies to improve sensitivity of brush cytology specimens. This would ultimately result in more effective use of health care resources and improve patient outcomes.
- Conditions
- Biliary Stricture
- Keywords
- ERCP, Positive Biliary Brush Cytology
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine factors associated with a positive yield of malignancy on biliary brush cytology obtained by ERCP determine the factors associated with a positive yield of malignancy on biliary brush cytology obtained by ERCP
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2009 (estimated)
- Study startJan 2009
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary StrictureStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mansour Parsi, MD, The Cleveland Clinic
- Investigators
- Mansour Parsi, M.D., Principal investigator, Staff Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00894348
- Sponsor's protocol ID
- IRB 09-032
- Acronym
- ERCP
- Status last verified
- Mar 2017
- First submitted
- 5 May 2009
- Last updated
- 30 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EXEMPT: Prospective Factors Predicting Positive Yields on Biliary Brush Cytology During Endoscopic Retrograde Cholangio-pancreatography (ERCP)
- ClinicalTrials.gov ID
- NCT00894348
- Acronym / sponsor ID
- ERCP / IRB 09-032
- Conditions
- Biliary Stricture
- Keywords
- ERCP, Positive Biliary Brush Cytology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 7 May 2009 (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 determine factors associated with a positive yield of malignancy on biliary brush cytology obtained by ERCP.
Detailed description
There are only 3 studies available that have tried to evaluate factors influencing the yield of brush cytology. Two of the 3 studied one parameter. The third study, which is also the largest, reported on 199 samples which the authors evaluated in a retrospect fashion. We plan to conduct a larger study assessing several other factors that have not been studied before. The study findings would help develop strategies to improve sensitivity of brush cytology specimens. This would ultimately result in more effective use of health care resources and improve patient outcomes.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing an ERCP for evaluation of biliary strictures
Key inclusion criteria (1 listed)
- ERCP Patients
Key exclusion criteria (1 listed)
- Non ERCP Patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To determine factors associated with a positive yield of malignancy on biliary brush cytology obtained by ERCP determine the factors associated with a positive yield of malignancy on biliary brush cytology obtained by ERCP
Time frame: 3 years
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 30 Mar 2017.
- Individual participant dataSharing planned: No
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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.
Mansour Parsi, M.D. principal investigator
Staff Physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Biliary Stricture, run by The Cleveland Clinic 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 1 inclusion and 1 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 30 Mar 2017. 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?
To determine factors associated with a positive yield of malignancy on biliary brush cytology obtained by ERCP determine the factors associated with a positive yield of malignancy on biliary brush cytology obtained by ERCP (time frame: 3 years). 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 30 Mar 2017.