Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12620000606987p
Ethics application status
Submitted, not yet approved
Date submitted
15/04/2020
Date registered
25/05/2020
Date last updated
25/05/2020
Date data sharing statement initially provided
25/05/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Imaging in Inflammatory Bowel Disease (IBD)- A 4 way comparison study
Scientific title
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.
Secondary ID [1] 301019 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inflammatory Bowel Disease 317060 0
Crohn's disease 317061 0
Ulcerative Colitis 317062 0
Condition category
Condition code
Oral and Gastrointestinal 315227 315227 0 0
Crohn's disease
Oral and Gastrointestinal 315576 315576 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 317333 0
Diagnosis / Prognosis
Intervention code [2] 317599 0
Treatment: Devices
Comparator / control treatment
All patients will receive same intervention (ie: the same diagnostic study intervention). As a result there will be no comparator/control arm. This is in keeping current clinical practice for Crohn's disease- which has no true, single gold standard. Diagnosis and assessment of Crohn's disease uses a combination of a number of different modalities. Therefore this trial will replicate "real world" settings and not have a gold standard. Instead, raw data of each modality will be described and compared with each other, rather than against a gold standard.
Control group
Active

Outcomes
Primary outcome [1] 323480 0
Proportion of patients with active inflammation as determined by each diagnostic modality (MRI, USS, colonoscopy, Pillcam Crohn's capsule)
Timepoint [1] 323480 0
week 52
Secondary outcome [1] 382030 0
Sensitivity of each diagnostic modality (MRI, USS, colonoscopy, Pillcam Crohn's capsule) in detection of active inflammation
Timepoint [1] 382030 0
week 52
Secondary outcome [2] 382966 0
Specificity of each diagnostic modality (MRI, USS, colonoscopy, Pillcam Crohn's capsule) in the detection of active inflammation.
Timepoint [2] 382966 0
52 weeks
Secondary outcome [3] 382967 0
Positive predictive value of each diagnostic modality (MRI, USS, colonoscopy, Pillcam Crohn's capsule) in the detection of active inflammation.
Timepoint [3] 382967 0
52 weeks
Secondary outcome [4] 382969 0
Negative predictive value of each diagnostic modality (MRI, USS, colonoscopy, Pillcam Crohn's capsule) in the detection of active inflammation.
Timepoint [4] 382969 0
52 weeks
Secondary outcome [5] 382970 0
Severity of inflammation detected by each diagnostic modality (MRI, USS, colonoscopy, Pillcam Crohn's capsule).
Timepoint [5] 382970 0
52 weeks

Eligibility
Key inclusion criteria
1. Age >/= 18 years
2. Established CD or UC
3. Written and informed consent to participate
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2021
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 305463 0
Hospital
Name [1] 305463 0
Concord Repatriation General Hospital
Country [1] 305463 0
Australia
Primary sponsor type
Hospital
Name
Concord Repatriation General Hospital
Address
Hospital Road
Concord
NSW
2139
Country
Australia
Secondary sponsor category [1] 305861 0
None
Name [1] 305861 0
Address [1] 305861 0
Country [1] 305861 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 305778 0
Sydney Local Health District HREC (CRGH)
Ethics committee address [1] 305778 0
Concord Repatriation General Hospital
Concord Hospital Research Office
Hospital Road
Concord
2139
New South Wales
Ethics committee country [1] 305778 0
Australia
Date submitted for ethics approval [1] 305778 0
01/05/2020
Approval date [1] 305778 0
Ethics approval number [1] 305778 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101566 0
Prof Rupert Leong
Address 101566 0
Concord Hospital
Ambulatory Care and Endoscopy
Hospital Road
Concord
NSW 2139
Country 101566 0
Australia
Phone 101566 0
+61 2 97676111
Fax 101566 0
Email 101566 0
[email protected]
Contact person for public queries
Name 101567 0
Prof Rupert Leong
Address 101567 0
Concord Hospital
Ambulatory Care and Endoscopy
Hospital Road
Concord
NSW 2139
Country 101567 0
Australia
Phone 101567 0
+61 2 97676111
Fax 101567 0
Email 101567 0
[email protected]
Contact person for scientific queries
Name 101568 0
Prof Rupert Leong
Address 101568 0
Concord Hospital
Ambulatory Care and Endoscopy
Hospital Road
Concord
NSW 2139
Country 101568 0
Australia
Phone 101568 0
+61 2 97676111
Fax 101568 0
Email 101568 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
7632Study protocol  [email protected]
7633Informed consent form  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.