Biliary StrictureNCT00892632
Confocal Endomicroscopy for Biliary Strictures -Phase I
A study testing ERCP and Confocal imaging in people with Biliary Stricture, run by Mayo Clinic at 1 site in United States.
Trial summary
The investigators hypothesize that the confocal endomicroscopy imaging of the biliary strictures during ERCP will differentiate between benign and malignant strictures in vivo and has increased sensitivity compared to biliary brushing/biopsy, and that direct cholangioscopic guidance of pCLE is more accurate than… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Stricture
- What is being tested?
- ERCP and Confocal imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Feb 2011
- 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
- Pre-ERCP: Age above 18; imaging consistent with stenosis/mass of the hilum/extra-hepatic bile duct with abnormal liver chemistry, or painless jaundice referred for ERCP.
- Evidence of biliary obstruction as defined by elevated direct bilirubin (> 1.5ULN) and dilation of the common or hepatic ducts > 8mm) on imaging studies.
Who cannot join
- Unwilling/unable to consent.
- Definite pancreatic mass on CT/MR.
- Allergy to Fluorescein.
- Pregnancy (patient who could be pregnant will undergo pregnancy testing as per routine care)
- Indwelling metal biliary stent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of Confocal Endomicroscopy for Biliary Strictures - Phase I
The investigators hypothesize that the confocal endomicroscopy imaging of the biliary strictures during ERCP will differentiate between benign and malignant strictures in vivo and has increased sensitivity compared to biliary brushing/biopsy, and that direct cholangioscopic guidance of pCLE is more accurate than fluoroscopic guidance.
Read the detailed description
Despite recent advances in biliary imaging and biliary tissue acquisition, the diagnosis and tissue-confirmation in suspected malignant biliary obstruction remains challenging. Patients often undergo repeat endoscopic and cross sectional imaging procedures, and even surgical exploration to establish a diagnosis. A major new advancement in cancer imaging is the development of a probe-based confocal endomicroscopy (pCLE) system capable of cellular and sub-cellular imaging of the biliary tree. Preliminary data suggests that pCLE can accurately detect or exclude malignancy within otherwise indeterminate strictures. In this study, we propose to validate these preliminary findings and compare two methods of pCLE image acquisition that are important for clinical translation of the technology.
This is a Phase 1 Study: During this study, in vivo microscopic images of 10 benign (post-operative from know benign disease such as orthotopic liver transplant) and 10 malignant (cytology-positive) strictures will be obtained at ERCP. Patients clinical course will be followed and a composite gold standard will be used for comparison to pCLE. These confocal images of biliary lesions will be reviewed side by side, unblinded to the reference standard by the endoscopists. The basic image characteristics allowing distinction between benign and malignant tissue will be established (details of features noted and examined are below). We will also assess whether good quality images can be feasibly obtained without the cholangioscopic guidance.
- Conditions
- Biliary Stricture
- Being tested
- ERCP and Confocal imaging
- Keywords
- Biliary Strictures, Cholangiocarcinoma, ERCP
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERCP and Confocal imagingProcedure or surgery
A major new advancement in cancer imaging is the development of a probe-based confocal endomicroscopy (pCLE) system capable of cellular and sub-cellular imaging of the biliary tree.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 1. To compare confocal image characteristics of benign vs. malignant biliary strictures Receives: Procedure: ERCP and Confocal imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Aim: 1. To compare confocal image characteristics of benign vs. malignant biliary strictures.
Measured: one year
Secondary outcomes (1)
Secondary Aim: 1. To compare the technical feasibility (percentage of images rated as adequate or better) and the quality of the images obtained via fluoroscopy-guided pCLE versus cholangioscopy-guided pCLE.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2009 (estimated)
- Study startApr 2009
- Primary completionFeb 2011
- Study completionFeb 2011
Why it stopped: Difficult (slow) Enrollment
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 Mayo 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Leadiant Biosciences, Inc.
- Responsible party
- Principal investigator, Michael Wallace, Mayo Clinic
- Investigators
- Michael B. Wallace, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00892632
- Sponsor's protocol ID
- 08-008669
- Status last verified
- Feb 2012
- First submitted
- 1 May 2009
- Last updated
- 24 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Confocal Endomicroscopy for Biliary Strictures - Phase I
- ClinicalTrials.gov ID
- NCT00892632
- Acronym / sponsor ID
- 08-008669
- Conditions
- Biliary Stricture
- Keywords
- Biliary Strictures, Cholangiocarcinoma, ERCP
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficult (slow) Enrollment
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Leadiant Biosciences, Inc.
- Study start
- Apr 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 4 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.
The investigators hypothesize that the confocal endomicroscopy imaging of the biliary strictures during ERCP will differentiate between benign and malignant strictures in vivo and has increased sensitivity compared to biliary brushing/biopsy, and that direct cholangioscopic guidance of pCLE is more accurate than fluoroscopic guidance.
Detailed description
Despite recent advances in biliary imaging and biliary tissue acquisition, the diagnosis and tissue-confirmation in suspected malignant biliary obstruction remains challenging. Patients often undergo repeat endoscopic and cross sectional imaging procedures, and even surgical exploration to establish a diagnosis. A major new advancement in cancer imaging is the development of a probe-based confocal endomicroscopy (pCLE) system capable of cellular and sub-cellular imaging of the biliary tree. Preliminary data suggests that pCLE can accurately detect or exclude malignancy within otherwise indeterminate strictures. In this study, we propose to validate these preliminary findings and compare two methods of pCLE image acquisition that are important for clinical translation of the technology.
This is a Phase 1 Study: During this study, in vivo microscopic images of 10 benign (post-operative from know benign disease such as orthotopic liver transplant) and 10 malignant (cytology-positive) strictures will be obtained at ERCP. Patients clinical course will be followed and a composite gold standard will be used for comparison to pCLE. These confocal images of biliary lesions will be reviewed side by side, unblinded to the reference standard by the endoscopists. The basic image characteristics allowing distinction between benign and malignant tissue will be established (details of features noted and examined are below). We will also assess whether good quality images can be feasibly obtained without the cholangioscopic guidance.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: ERCP and Confocal imaging1. To compare confocal image characteristics of benign vs. malignant biliary strictures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Pre-ERCP: Age above 18; imaging consistent with stenosis/mass of the hilum/extra-hepatic bile duct with abnormal liver chemistry, or painless jaundice referred for ERCP.
- Evidence of biliary obstruction as defined by elevated direct bilirubin (> 1.5ULN) and dilation of the common or hepatic ducts > 8mm) on imaging studies.
Key exclusion criteria (5 listed)
- Unwilling/unable to consent.
- Definite pancreatic mass on CT/MR.
- Allergy to Fluorescein.
- Pregnancy (patient who could be pregnant will undergo pregnancy testing as per routine care)
- Indwelling metal biliary stent.
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 and Confocal imagingA major new advancement in cancer imaging is the development of a probe-based confocal endomicroscopy (pCLE) system capable of cellular and sub-cellular imaging of the biliary tree. | Procedure or surgery | 1 |
Primary outcome
Primary Aim: 1. To compare confocal image characteristics of benign vs. malignant biliary strictures.
Time frame: one year
1 secondary outcome
Secondary Aim: 1. To compare the technical feasibility (percentage of images rated as adequate or better) and the quality of the images obtained via fluoroscopy-guided pCLE versus cholangioscopy-guided pCLE.
Time frame: One year
Results and safety
The study was stopped early (reason given: Difficult (slow) Enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2012.
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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.
Michael B. Wallace, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ERCP and Confocal imaging in people with Biliary Stricture, run by Mayo 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 2 inclusion and 5 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: stopped early, as of the sponsor's last update on 24 Feb 2012. 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 was stopped early (reason given: Difficult (slow) Enrollment). Results are not available in the source record.
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?
Primary Aim: 1. To compare confocal image characteristics of benign vs. malignant biliary strictures. (time frame: one year). 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 24 Feb 2012.