Confocal Laser Endomicroscopy Findings in Patients With Proctosigmoiditis Before and After Initiation of Treatment

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Herlev Hospital
Sponsor:
Information provided by (Responsible Party):
John Gasdal Karstensen, Herlev Hospital
ClinicalTrials.gov Identifier:
NCT01684514
First received: September 6, 2012
Last updated: November 19, 2012
Last verified: November 2012
  Purpose

Confocal laser endomicroscopy (CLE) is a novel method in evaluation of microscopic structures in vivo. The examination is carried out with a confocal laser endomicroscope, which is either part of the endoscope (manufactured by Pentax) or probe based (manufactured by Cellvizio). Hereby, all parts of the gastrointestinal (GI) tract can be examined. The method has potential to replace conventional microscopy and the dynamic nature of the procedure allows visualization of structures and cellular processes in almost real-time. This provides us with a potentially new diagnostic tool with a promising future. To date only a few studies have been published on inflammatory bowel disease (IBD) and in the literature high-quality research is still lacking.

The project consists of a blinded prospective observation and methodology study including inter- and intra-observation of patients with proctitis before and after initiation of local treatment.

Hypothesis: CLE can be used to assess the degree and extend of acute and chronic inflammation and treatment response in patients with ulcerative colitis and is a sensitive supplementary to conventional diagnostics.


Condition Intervention
Colitis, Ulcerative
Device: Confocal laser endomicroscopy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Official Title: Confocal Laser Endomicroscopy Findings in Patients With Proctosigmoiditis Before and After Initiation of Treatment

Resource links provided by NLM:


Further study details as provided by Herlev Hospital:

Primary Outcome Measures:
  • CLE findings are recorded and compared with the findings of conventional colonoscopy (Mayo score), including observations for the control group [ Time Frame: The trial will go on for 2 years ] [ Designated as safety issue: No ]
  • CLE and colonoscopy findings are compared with the pathological evaluation of tissue samples. [ Time Frame: The trial will go on for 2 years ] [ Designated as safety issue: No ]
  • Intra-and inter-observer agreement between 3 CLE operators is calculated by kappa statistics [ Time Frame: The trial will go on for 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effect of therapy with topical therapy, based on the results of the conventional colonoscopy and CLE [ Time Frame: The trial will go on for 2 years ] [ Designated as safety issue: No ]
    A determination of the relationship between CLE findings (the parameters described in the protocol and validated in the inter- and intra-observer study) and conventional colonoscopy findings (Mayo-score) with the treatment effect for the individual patient is conducted. To evaluate the treatment effect the Wilcoxon Signed Rank test is used.

  • Registering time of the procedure. [ Time Frame: The trial will go on for 2 years ] [ Designated as safety issue: No ]
  • Registering possible complications [ Time Frame: The trial will go on for 2 years ] [ Designated as safety issue: Yes ]
    Registering possible complications meaning intestinal perforations and bleeding


Estimated Enrollment: 36
Study Start Date: October 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: colitis, ulcerative
Enrolled patients will be examined by conventional colonoscopy and confocal laser endomicroscopy before and after initiation of topical treatment, respectively.
Device: Confocal laser endomicroscopy
Within recent years a new approach was introduced, wherein the microscopic structures of the intestinal mucous can be evaluated continuously in vivo during the endoscopic procedure. The technique is called confocal laser endomicroscopy (CLE). CLE functions by means of a laser device, which is inserted or build into an endoscope, and used as an illuminator of the lining of a small area and at a precise depth. The tissue is first added with fluorescence by intravenous administration. The reflection of the mucosa is captured in a focused area and magnified by which a two-dimensional image of mucosal microscopic structures is formed. This provides us with an "optical biopsy", which can be compared with a similar microscopic image.
Sham Comparator: Control group
A control group will be examined by conventional colonoscopy and confocal laser endomicroscopy.
Device: Confocal laser endomicroscopy
Within recent years a new approach was introduced, wherein the microscopic structures of the intestinal mucous can be evaluated continuously in vivo during the endoscopic procedure. The technique is called confocal laser endomicroscopy (CLE). CLE functions by means of a laser device, which is inserted or build into an endoscope, and used as an illuminator of the lining of a small area and at a precise depth. The tissue is first added with fluorescence by intravenous administration. The reflection of the mucosa is captured in a focused area and magnified by which a two-dimensional image of mucosal microscopic structures is formed. This provides us with an "optical biopsy", which can be compared with a similar microscopic image.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Patients with active proctitis or proctosigmoiditis due to ulcerative colitis, where an indication for treatment and colonoscopy exists. Newly diagnosed as well as patients already in oral 5-ASA therapy, may be included.

The control group will consist of patients without known or suspected IBD. Patients must be of legal age. Patients who have received written informed consent.

Exclusion Criteria:

Increased p-creatinine and/or demonstrated allergy to fluorescein. Pregnant and lactating women. Ongoing systemic immunosuppressive therapy with prednisolone, azathioprine or biological agents.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01684514

Contacts
Contact: John G Karstensen, MD +45 40944465 john.gasdal.karstensen.01@regionh.dk
Contact: Peter Vilmann, professor +45 38683868 peter.vilmann.01@regionh.dk

Locations
Denmark
John Gásdal Karstensen Recruiting
Birkerød, Denmark, 3460
Contact: John Gásdal Karstensen    40944465    johngkarstensen@hotmail.com   
Principal Investigator: John G Karstensen, MD         
Gastroenheden, Herlev Hospital Recruiting
Herlev, Denmark, 2730
Contact: John G Karstensen, MD    +45 40944465    john.gasdal.karstensen.01@regionh.dk   
Contact: Peter Vilmann, professor    +45 38683868    peter.vilmann.01@regionh.dk   
Sponsors and Collaborators
Herlev Hospital
Investigators
Principal Investigator: John G Karstensen, MD Gastroenheden, Herlev Hospital
  More Information

Publications:

Responsible Party: John Gasdal Karstensen, MD, ph.d.-student, Herlev Hospital
ClinicalTrials.gov Identifier: NCT01684514     History of Changes
Other Study ID Numbers: H-1-2012-089 sub-1
Study First Received: September 6, 2012
Last Updated: November 19, 2012
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by Herlev Hospital:
confocal laser endomicroscopy
inflammatory bowel disease
colitis, ulcerative

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases

ClinicalTrials.gov processed this record on October 19, 2014