The Value of I-Scan and Confocal Laser Endomicroscopy for the Assessment of Chronic Inflammatory Bowel Disease

NCT02481687 | Terminated DMC

• 1 other identifier: I-Scan-CLE-IBD
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Recently, Confocal Laser Endomicroscopy (CLE) has been developed as a novel technique that actually enables in vivo microscopic analysis of the gastrointestinal tract, during ongoing endoscopy. The potential role of CLE has been explored in pathology of both upper and lower gastrointestinal tract, showing good accuracy for predicting the final histopathological diagnosis, based on immediate evaluation of tissue and vascular patterns. Because of its minute scanning area, this techology is best used in conjunction with other "red-flag" techniques to screen the mucosa for areas of interest, which can then be examined by CLE for a histological diagnosis. I-scan technology (Pentax, Tokyo, Japan) is a new image-enhanced endoscopic technique that can achieve a virtual chromoendoscopy, but until now there have been no studies to determine the role of this technology in the evaluation of activity in inflammatory bowel disease. The study protocol is based on comparing imaging findings of p-CLE in conjunction with I-scan endoscopy with activity score and histological diagnosis of inflammatory bowel disease. CLE might have an important role in IBD patients management, by assessing the inflammation, dysplasia or response to treatment.

Conditions

Inflammatory Bowel Disease; Crohn's Disease; Ulcerative Colitis; Dysplasia

Outcome Measures

Primary Outcomes (1)

• p-CLE findings during conventional colonoscopy and I-scan colonoscopy.

  12 months

Study Arms (2)

Ulcerative colitis

Consecutively admitted patients with active ulcerative colitis, confirmed by histopathology. I-SCAN and pCLE will be applied in all patients.

Other: Confocal laser endomicroscopy

Crohn's disease

Consecutively admitted patients with active Crohn's disease, confirmed by histopathology. I-SCAN and pCLE will be applied in all patients.

Other: Confocal laser endomicroscopy

Interventions

Confocal laser endomicroscopy OTHER

Probe based confocal laser endomicroscopy is a contrast based technique, consisting of a flexible catheter probe representing a bundle of optical fibers linked to a micro-objective a laser scanning unit and the control and acquisition software. The flexible confocal miniprobes can be passed through the working channels of standard endoscopes. The principle of the technique is based on a laser beam of defined wavelength being focused towards the targeted tissue and the recaptured signal is displayed as 'optical biopsies' in a single horizontal plane. The device was intended to be used for faster diagnosis and evaluation of gut diseases, by allowin in vivo histology.

Crohn's disease; Ulcerative colitis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with active ulcerative colitis or Crohn's disease who meet the inclusion and exclusion criteria will be included in the study. Personal data (name, surname, age, sex), results from previous investigations, clinical evaluation (stools frequency, rectal bleeding, fever, abdominal pain, extra intestinal manifestation, abdominal mass) and blood count for activity index calculator (Mayo score for ulcerative colitis, respectively CDAI score for Crohn disease), endoscopic findings, histological and immunohistochemical findings, molecular analysis findings, will be registered in the study. p-CLE has shown its utility in both upper and lower GI tract. I-SCAN isn't widely used, so more studies are needed to prove its utility. Anyway, signed informed consent for colonoscopy, i-SCAN colonoscopy and pCLE examination is required for participation in the study

You may qualify if:

• Age \> 18 years old, male or female
• Patients diagnosed with active ulcerative colitis (MAYO score \>3) or Crohn's disease (CDAI score \>150), where an indication for treatment and colonoscopy exists. Newly diagnosed as well as patients already on oral 5-ASA therapy, may be included.
• Signed informed consent for colonoscopy and p-CLE examination

You may not qualify if:

• Failure to provide informed consent
• Patients with a contraindication to colonoscopy
• Known allergy to fluorescein
• Pregnant or breast-feeding patients
• Ongoing systemic immunosuppressive therapy with prednisolone, azathioprine or biological agents.

Sponsors & Collaborators

• University of Medicine and Pharmacy Craiova: lead
• Copenhagen University Hospital at Herlev: collaborator

Study Sites (1)

Research Center of Gastroenterology and Hepatology

Craiova, 200369, Romania

Location

Biospecimen

Retention: SAMPLES WITH DNA

One ml of whole blood and tissue biopsies from normal tissue and from modified areas of 2 to 3 mm each for molecular analysis.

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Adrian Saftoiu, MD PhD FASGE

  University of Medicine and Pharmacy Craiova

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2015
• First Posted: June 25, 2015
• Study Start: June 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: January 17, 2018

Record last verified: 2018-01

Locations

RO (1)