Capsule Colonoscopy in Crohn's Disease and Its Correlation With Conventional Colonoscopy and Faecal Calprotectin
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|ClinicalTrials.gov Identifier: NCT02624414|
Recruitment Status : Recruiting
First Posted : December 8, 2015
Last Update Posted : August 28, 2019
- To study the feasibility of capsule colonoscopy in patients with Crohn's Disease (CD).
- To compare the results of capsule colonoscopy with conventional colonoscopy in assessing mucosal healing.
- To correlate the level of faecal calprotectin with the results of capsule colonoscopy and conventional colonoscopy.
- To document changes in clinical practice attributable to the capsule colonoscopy findings a) concordant with and b) in addition to the parallel findings at colonoscopy and ileoscopy.
Project design: Cross sectional, prospective, comparative study
Methodology: Patients of the Royal Melbourne Hospital (RMH) and other associated speciality clinics with an established diagnosis of CD who need assessment of mucosal healing and have consented to be part of the study will undergo capsule colonoscopy and conventional colonoscopy on the same day after undergoing bowel preparation. The images of both the conventional and capsule colonoscopies will be recorded. In addition calprotectin (an inflammatory marker in faeces) will be measured in a sample of faeces collected by the patients prior to the colonoscopy day.
Professor Macrae and the scholarly selective student researcher will assess the recorded images obtained from capsule colonoscopies once the images have been deidentified.
To assess the level of mucosal disease they will use the Simple Endoscopic Score for CD (SESCD).
The results of the assessment of mucosal healing obtained from conventional colonoscopy will be compared with those of capsule colonoscopy and levels of faecal calprotectin will then be correlated.
|Condition or disease||Intervention/treatment||Phase|
|Crohn's Disease||Device: PillCam® COLON 2 Capsule Endoscopy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Prospective Study of the Feasibility of Capsule Colonoscopy in Crohn's Disease and Its Correlation With Conventional Colonoscopy and Faecal Calprotectin|
|Actual Study Start Date :||February 6, 2015|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2022|
Anti TNF induction therapy 6-12 months
All subjects will be identified through The Royal Melbourne Hospital's IBD clinic, associated specialty clinics and the colonoscopy waiting list of The Royal Melbourne Hospital. The potential participants who have been commenced on Anti TNF induction therapy 6-12 months prior to commencement of the study will be identified. The potential participants identified in this way will be informed of the project at the time of contact and assessment; in some instances the potential participant will be informed of the project via telephone where subjects are remote. The potential participants will be provided an Ethically-approved information sheet at this time. Consent will be gained at the time of assessment.
Device: PillCam® COLON 2 Capsule Endoscopy
- Assess bowel cleanness based on the % of mucosal surface visualized by the Capsule colonoscopy [ Time Frame: 24 months ]
The quality of bowel preparation will be assessed using a new grading system proposed by Segal, et al, University of Melbourne Honours thesis in preparation, 2014. The investigator will assess five colonic segments (cecum, ascending, transverse and descending colon and the rectum). The investigator will assess bowel cleanness based on the % of mucosal surface visualized by the capsule for the presence of: Faecal residue, Turbid Fluid, Bubbles , Faecal residue on Dome, Rapid movement , Poor lighting, Light reflection.
Each segment will be given a number out of 4: 0 =not present and 4=significantly prevented mucosal visualization.
SES-CD= sum of the above 4 variables for 5 bowel segments (rectum, sigmoid and ascending colon, transverse colon, descending colon and ileum.
The images taken during this procedure will be recorded and analysed at a later date.
- Simple Endoscopic Score for Crohn's Disease from Conventional colonoscopy [ Time Frame: 24 months ]
- Levels of Faecal calprotectin [ Time Frame: 24 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02624414
|Contact: Finlay Macraefirstname.lastname@example.org|
|Contact: Zafirah Khanemail@example.com|
|Principal Investigator:||Finlay Macrae||Melbourne Health|