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Imaging in Inflammatory Bowel Disease (IBD)- A 4 way comparison study

Imaging in Inflammatory Bowel Disease (IBD)- A 4 way comparison study of diagnostic modalities using colonoscopy, magnetic resonance imaging (MRI), ultrasound and Pillcam Crohn's capsule.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620000606987
Enrollment
200
Registered
2020-05-25
Start date
2021-02-01
Completion date
Unknown
Last updated
2020-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The diagnosis and monitoring of inflammatory bowel diseases, such as Crohn’s disease and ulcerative colitis, involves many different tests including blood and stool tests, imaging tests and endoscopic tests. These tests are used to assess disease extent and severity. The technology involved in imaging and endoscopic tests has advanced significantly in recent times. Newer generations of these tests are available and are being used in clinical practice. However, to date, these tests haven’t been compared directly with each other. This study aims to assess the accuracy of different disease assessment tests in patients with inflammatory bowel disease. Participants will undergo diagnostic assessments (colonoscopy, MRI, ultrasound and Pillcam Crohn's capsule) at 2 time points- 1 year apart. Colonoscopy, MRI and ultrasound all form part of routine disease assessment for patients with IBD and the use of these assessments during the study will not be different to standard care. The Pillcam Crohn's capsule is not yet part of routine care, but is merely an updated, higher definition iteration of existing capsule endoscopy systems. The risks associated with the Pillcam Crohn's capsule are no different to standard capsule endoscopy. Previous versions of capsule endoscopy have been shown to be comparable to other diagnostic modalities in the assessment of inflammatory burden in inflammatory bowel disease patients. The study protocol describes the interventions in more detail including the preparation required and disease indices measured. We believe that the Pillcam Crohn's device will be as accurate as the current diagnostic methods at detecting extent and severity of inflammation related to inflammatory bowel disease.

Interventions

Participants will undergo diagnostic assessments (colonoscopy, MRI, ultrasound and Pillcam Crohn's capsule) at 2 time points- 1 year apart. Colonoscopy, MRI and ultrasound all form part of routine disease assessment for patients with IBD and the use of these assessments during the study will not be different to standard care. The Pillcam Crohn's capsule is not yet part of routine care, but is merely an updated, higher definition iteration of existing capsule endoscopy systems. The risks associat

Participants will undergo diagnostic assessments (colonoscopy, MRI, ultrasound and Pillcam Crohn's capsule) at 2 time points- 1 year apart. Colonoscopy, MRI and ultrasound all form part of routine disease assessment for patients with IBD and the use of these assessments during the study will not be different to standard care. The Pillcam Crohn's capsule is not yet part of routine care, but is merely an updated, higher definition iteration of existing capsule endoscopy systems. The risks associated with the Pillcam Crohn's capsule are no different to standard capsule endoscopy. Previous versions of capsule endoscopy have been shown to be comparable to other diagnostic modalities in the assessment of inflammatory burden in inflammatory bowel disease patients. The procedures will be performed within a 2 week period, so that they are able to be compared to each other as accurately as possible. There is no prescribed order of interventions, however the person reporting each intervention will be blinded to the results of the patient's other interventions. Colonoscopy- this is a standard diagnostic and therapeutic procedure for patients with inflammatory bowel disease. It involves taking a bowel cleansing preparation 1 day prior to the procedure. The procedure involves having a sedative medication administered and a camera with a light is inserted via the anus/rectum to pass through the entire large bowel. The large bowel and last few centimetres of the small bowel is examined by the colonoscope. The procedure usually takes between 15 to 45 minutes and will be performed by a gastroenterologist. Capsule endoscopy- This procedure involves having a similar bowel cleansing preparation as a colonoscopy. The patient will then ingest/swallow a capsule (that has a camera and light within it) and have a monitoring device attached to a waist belt. The capsule will take pictures of the patient's entire gastrointestinal tract and then pass in their stool into the toilet. The patient will then return the monitoring device to the hospital that same afternoon for uploading of the capsule pictures. This procedure will be facilitated by a gastroenterologist or a lab technician familiar with administering this test. The capsule procedure (from ingestion to excretion) usually takes 6-8 hours, but varies according to the individual. MRI- this is a diagnostic radiologic procedure that will be performed by radiographers. It involves lying in the MRI machine and having images taken of the patient's abdomen and internal organs. This procedure usually takes 40-60 minutes. Ultrasound- this is also a diagnostic radiologic procedure that will be performed by a gastroenterologist. This procedure involves having lubricating jelly applied to the patient's abdomen and an external probe placed on the abdomen to allow pictures to be taken of the patient's internal organs and intestines. This usually takes 10-20 minutes. No specific preparation is required for this procedure.

Sponsors

Concord Repatriation General Hospital
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Primary purpose
Diagnosis

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Age >/= 18 years 2. Established CD or UC 3. Written and informed consent to participate

Exclusion criteria

1. Women who are pregnant or are actively trying to fall pregnant 2. Patients taking non-steroidal anti-inflammatory drugs (NSAIDs) more than once a week in the 4 weeks leading up to disease re-assessment (either at baseline or at week 52) 3. Patients who are unable to communicate with the investigators and comply with the study requirements.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026