Clinical trial NCT02624414: Capsule Colonoscopy in Crohn's Disease and Its Correlation With Conventional Colonoscopy and Faecal Calprotectin
Official title: A Prospective Study of the Feasibility of Capsule Colonoscopy in Crohn's Disease and Its Correlation With Conventional Colonoscopy and Faecal Calprotectin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Crohn's Disease
Lead sponsor: Melbourne Health
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2015-12-08
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Aims:

* 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.


Eligibility criteria: Inclusion Criteria:

* Adults with established diagnosis of CD with ileal, colonic or ileo-colonic disease aged 18-75 years. Gender: both male and female
* Patients of RMH IBD clinic and other specialty clinics where assessment of mucosal healing is clinically indicated this includes: Patients who have had Anti TNF induction therapy 6-12 months prior to commencement of this study AND/OR Patients referred for colonoscopy to assess mucosal disease status with a view to treatment escalation based on the findings.

Exclusion Criteria:

Patients must not:

* Have known/suspected gastrointestinal obstruction
* Have swallowing disorder
* Have a known oesophageal stricture
* Have severe gastroparesis
* Have dementia
* Have a cardiac pacemaker or other implanted medical device
* Have sever cardiac or renal insufficiency
* Have a previous allergy or contraindication to bowel preparation
* Be pregnant
* Prior major abdominal surgery
* Colonoscopy is contraindicated

Primary outcomes:
measure: Assess bowel cleanness based on the % of mucosal surface visualized by the Capsule colonoscopy
timeFrame: 24 months
measure: Simple Endoscopic Score for Crohn's Disease from Conventional colonoscopy
timeFrame: 24 months
measure: Levels of Faecal calprotectin
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
Study officials:
affiliation: Melbourne Health
name: Finlay Macrae
role: PRINCIPAL_INVESTIGATOR
References: