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Completed

NCT Number: NCT02624414

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

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.

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Key information

Conditions

Crohn's Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PillCam® COLON 2 Capsule Endoscopy

Device

Primary outcomes

  1. 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.

  2. Simple Endoscopic Score for Crohn's Disease from Conventional colonoscopy

    Time frame: 24 months

  3. Levels of Faecal calprotectin

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Melbourne Health

Other

Collaborators

  • Medtronic

Registry information

Official study title

A Prospective Study of the Feasibility of Capsule Colonoscopy in Crohn's Disease and Its Correlation With Conventional Colonoscopy and Faecal Calprotectin

Important dates

Study start
2015
Primary completion
2020
Study completion
2022
First posted
Dec 8, 2015
Registry last updated
Nov 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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