Clinical trial NCT00596700: Capsule Endoscopy Crohn's Disease Activity Index - Validation Multi Center Study
Official title: Capsule Endoscopy Crohn's Disease Activity Index - Validation Multi Center Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Crohn's Disease
Keywords: Capsule endoscopy
Crohn's disease
IBD
Activity score
Small bowel
Crohn's disease of the small bowel in any stage
Recruiting
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
Collaborators: name: US Department of Veterans Affairs
name: Rambam Health Care Campus
name: Assaf-Harofeh Medical Center
name: Hillel Yaffe Medical Center
name: University of Athens
name: University of Magdeburg
First posted: 2008-01-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The Study

1. Prospective trial of the Niv score validating score against known activity indices - see addendum A for Niv score
2. Known Crohn's disease patients undergoing capsule endoscopy are identified - see addendum B for inclusion/exclusion criteria
3. Prior to capsule exam, temperature is taken, height and weight measured, bloods are drawn for albumin, ESR, HCT, CRP
4. Prior to capsule exam, symptom/exam questionnaire is completed - see addendum C for questionnaire
5. Capsule exam is performed
6. CD of de-identified is made at the study site.
7. Landmarks are confirmed and the small bowel transit time is divided into 2 and labeled on thumbnails
8. CDs are copied
9. CDs of study patients are provided to blinded readers

Detailed description: The Niv score was devised to measure mucosal disease activity in Crohn's disease using capsule endoscopy. This scoring index is based on inflammatory score parameters: Erythema, hyperemia, edema, denudation, nodularity, apthae, erosion, ulcer, bleeding), extent score: Focal, patchy, diffuse, and stricture score: single-passed, multiple-passed, obstruction. The higher the score, the more involvement is observed. The advantage of this index is that it actually measures disease activity and not symptoms in an easy non-invasive manner. For assessing Crohn's disease, mucosal healing can be directly seen and if there is no mucosal disease there can be no symptoms secondary to inflammatory bowel disease. The subjective nature of disease activity indices is avoided, as is the problem of disease without symptoms. It is envisioned that the Niv score could diagnose Crohn's disease (excluding normally occurring mucosal breaks), identify NSAID damage, measure disease activity / severity, measure drug response for clinical trials and in practice, and guide medical management for the patient's with small bowel Crohn's disease.

This study will measure the Niv score against CDAI. Since capsule endoscopy assesses mucosal disease and not symptoms it is not envisioned that the Niv score will perfectly correlate with the Harvey-Bradshaw score. It is envisioned that the Niv score will have the same direction. Both of these indices will be determined as part of a multicenter trial. The trial design is outlined below.

The Study

1. Prospective trial of the Niv score validating score against known activity indices - see addendum A for Niv score
2. Known Crohn's disease patients undergoing capsule endoscopy are identified - see addendum B for inclusion/exclusion criteria
3. Prior to capsule exam, temperature is taken, height and weight measured, bloods are drawn for albumin, ESR, HCT, CRP
4. Prior to capsule exam, symptom/exam questionnaire is completed - see addendum C for questionnaire
5. Capsule exam is performed
6. CD of de-identified is made at the study site.
7. Landmarks are confirmed and the small bowel transit time is divided into 2 and labeled on thumbnails
8. CDs are copied
9. CDs of study patients are provided to blinded readers

   Scoring sheets will be provided to readers - see addendum A
10. Readers will score the CDs and return the scoring sheets to the principal investigator
11. Data is collated and analyzed

Eligibility criteria: Inclusion Criteria:

* Patients 18 years or older and not greater than 80 years suffer from Crohn's Disease of the small bowel, documented by clinical, endoscopical, histopathological and radiological parameters, in any activity stage iof the disease and any treatment
* Documented written Informed Consent

Exclusion Criteria:

* Subject suffers from swallowing difficulties
* Female subject is pregnant or nursing (in case of necessary small bowel series a pregnancy test has to be performed prior to the test)
* Subject is known to suffer from intestinal obstruction
* Subject has a cardiac pacemakers or other implanted electro medical devices
* Patients with more than 40% small bowel resect
* Subject has any condition, which precludes compliance with study and/or device instructions
* Subject suffers from life threatening conditions
* Subject is currently participating in another clinical study
* Subject with colonic involvement of Crohn's disease

Primary outcomes:
measure: This prospective study is aimed to evaluate the correlation of capsule endoscopy CECDAI with the CDAI (accepted clinical index) and IBDQ (quality of life questionnaire) in patients suffering from small-bowel Crohn's disease
timeFrame: Two years
Secondary outcomes:
measure: Capsule endoscopy investigation and crohn's disease outcome
timeFrame: Two years
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Triniti College
city: Hadera
country: Israel
facility: Hillel Jafa Medical Center
city: Petach Tikva
country: Israel
facility: Rabin Medical Center, Beilinson Hospital, Tel Aviv University
city: Zrifin
country: Israel
facility: Asaf Harofe Medical Center
Study officials:
affiliation: RMC, Tel Aviv University
name: Yaron Niv, MD, AGAF
role: PRINCIPAL_INVESTIGATOR
References: