Capsule Colonoscopy in Crohn's Disease and Its Correlation With Conventional Colonoscopy and Faecal Calprotectin

NCT ID: NCT02624414

Last Updated: 2022-11-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-06
• Study Completion Date: 2022-05-05

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.

Conditions

Crohn's Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

PillCam® COLON 2 Capsule Endoscopy

Intervention Type: DEVICE

Interventions

PillCam® COLON 2 Capsule Endoscopy

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

Melbourne Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Finlay Macrae

Role: PRINCIPAL_INVESTIGATOR

Melbourne Health

Locations

Royal Melbourne Hospital

Parkville, Victoria, Australia

Countries

Australia

Other Identifiers

2014.214

Identifier Type: -

Identifier Source: org_study_id