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

NCT02624414 | Completed

• 1 other identifier: 2014.214
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Assess bowel cleanness based on the % of mucosal surface visualized by the Capsule colonoscopy

  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.

  24 months

• Simple Endoscopic Score for Crohn's Disease from Conventional colonoscopy

  24 months

• Levels of Faecal calprotectin

  24 months

Study Arms (1)

Anti TNF induction therapy 6-12 months

OTHER

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

Interventions

PillCam® COLON 2 Capsule Endoscopy DEVICE

Anti TNF induction therapy 6-12 months

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Melbourne Health: lead
• Medtronic: collaborator

Study Sites (1)

Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Finlay Macrae

  Melbourne Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2015
• First Posted: December 8, 2015
• Study Start: February 6, 2015
• Primary Completion: December 31, 2020
• Study Completion: May 5, 2022
• Last Updated: November 23, 2022

Record last verified: 2022-11

Locations

AU (1)