Endomicroscopy in Primary Sclerosing Cholangitis Related Inflammatory Bowel Disease Surveillance (pCLE-PSC-IBD)

April 24, 2015 updated by: Aldona Dlugosz, Karolinska University Hospital

Probe-based Confocal Laser Endomicroscopy in Colonoscopic Surveillance of Patients With Primary Slerosing Cholangitis Related Inflammatory Bowel Disease (PSC-IBD)

Evaluation of the efficacy of laser-based endomicroscopy as a complement to white-light colonoscopy and chromoendoscopy for early detection of colon dysplasia in patients with PSC-IBD. White-light colonoscopy is a routinely used procedure in colorectal cancer surveillance programs. However, it does not permit detection of early dysplastic lesions. Chromoendoscopy by applying a dye (indigo-carmine) through the colonoscope helps to identify flat lesions but is not suitable for accurate endoscopic diagnosis of dysplasia and intraepithelial neoplasia Under this aim we will perform a clinical study evaluating a newly developed technique allowing for in vivo confocal microscopy assessment of the colon mucosa using laser-based endomicroscopy together with intravenous administration of fluorescein (FITC).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Chromoendoscopy by applying a dye (indigo-carmine) through the colonoscop is the new standard for cancer surveillance in patients with IBD . It gives the opportunity to identify suspected areas of dysplasia and to take targeted biopsies. The diagnostic accuracy improves and the chances for detecting dysplastic areas increase. In recent years new endoscopic techniques have been developed, including laser-based endomicroscopy. There is an increasing need for structured evaluation of the efficiency of these techniques. Laser-based endomicroscopy, taking in vivo confocal microscopy pictures during the colonoscopy examination, is the most promising new method. This method is established in highly rated centers for the early diagnosis of neoplasia in the bile ducts and the esophagus but its role for detection early malignancies in the colon is not known and studying this issue is of very high clinical value.

Specific questions: Does the use of laser-based endomicroscopy increase the chances for early detection of dysplasia? What is the intraobserver variability? What is the learning curve for interpretation of confocal microscopy pictures? Material and methods: A laser-based endomicroscope (Cellvizio®, Mauna Kea Technologies) have been acquired and the examination procedure has been established at the Unit for Gastroenterology and Hepatology, Karolinska University Hospital Huddinge. Eighty patients with PSC and IBD included in annual surveillance with colonoscopy with routine biopsy regime will be included in the study. After informed consent, patients are investigated with laser-based endomicroscopy during surveillance colonoscopy. Each colonic segment will be examined before and after staining with indigo-carmin. After intra-venous fluorescein (FITC) injection, all macroscopically abnormal lesions will be examined by endomicroscopy. Intravenous administration of FITC makes it possible to obtain in vivo microscopic pictures with up to a 1000x magnification of the colon mucosa. The Cellvizio® technique allows for evaluation of epithelial and endothelial cell structures in areas with suspicious changes as well as for acquisition of directed biopsies. Confocal pictures from all sites where biopsies have been taken are saved for future blind re-evaluation. The biopsies are taken according to the routine standard with minimum of 2 biopsies from each 10 cm in the colon. For the immunological and microbiological (specific aim 2) parts of the study, additional 16 biopsies are gathered from left, transverse, and right colon. All the laser-based endomicroscopy pictures and sequences are saved for further evaluation and further application in arranging pedagogical sessions for evaluation of the learning curve of the technique.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
69

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 14186
        • Gastro Center Karolinska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Eighty patients with PSC and IBD included in annual surveillance with colonoscopy with routine biopsy regime will be included in the study.

Description

Inclusion Criteria:

  • clinical diagnosis of PSC-IBD

Exclusion Criteria:

  • the lack of informed consent, allergy to fluorescein, B-blockers treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
patients with PSC-IBD
Only patients, colonoscopy with endomicroscopy
Procedure: colonoscopy with endomicroscopy
Examination will be performed in two steps. On the way from rectum to caecum, mucosa will be evaluated with white light endoscopy and random biopsies will be taken according to the routine standard with minimum of 2 biopsies from each 10 cm of colon. On the way back (from caecum to rectum) mucosa will be stained with indigo carmine and after intravenous fluorescein injection all macroscopically abnormal lesions will be examined by endomicroscopy and biopsied. Additionally, all places where random biopsies were taken will be also examined with endomicrosopy.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Sensitivity and specificity of endomicroscopy versus white light endoscopy in detection of dysplastic lesions in colon using histological assesment as a gold standard.
Time Frame: one year
one year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
measurement of number of dysplastic lesions discovered by adding pCLE to white-light endoscopy
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Karolinska University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Annika Bergquist, PhD, Gastro Center Karolinska Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 12, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 19, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 27, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PSC-IBD2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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