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Crohn DiseaseANDINCT03134586

Advanced Non-Invasive Diagnostics in Inflammatory Bowel Disease

A study testing Diagnostic imaging in people with Crohn Disease, run by Esbjerg Hospital - University Hospital of Southern Denmark at 3 sites in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine whether Non-invasive endoscopic procedures (pillcam colon capsule endoscopy, PCCE) and non-ionizing radiological modalities (MR enterocolonography, MREC and ultrasound, US) - offer a sufficiently high diagnostic validity in patients with suspected CD compared to the… Read more about this study

Who is it for?
Ages 15 years and older
Conditions the study is for
Crohn Disease
What is being tested?
Diagnostic imaging
Could I receive a placebo?
No, everyone receives an active treatment
How many people
153 participants
Where
3 sitesDenmark
Study dates
Jun 2016to 23 Oct 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • General criterion
  • All of the following:
  • Clinical suspicion of CD
  • Age > 15 years
  • Negative serologic markers for celiac disease, negative stool culture (or polymerase chain reaction) for pathogenic bacteria and a negative microscopy for intestinal parasites
  • Fecal calprotectin > 50 mg/kg
  • Signed informed consent
  • Clinical criterion Diarrhea and/or abdominal pain for more than 1 month (or repeated episodes of diarrhea and/or abdominal pain) associated with one or more of the following findings: (1) C-reactive protein (CRP) >5 mg/L, (2) thrombocytosis (> 400 x 109/L), anemia (hemoglobin < 7.0 mmol/L for women and < 8.0 mmol /L for men or a decrease > 0.5 mmol/L compared to the usual level), (3) prolonged fever (> 37.5 C for more than 2 weeks), (5) weight loss (≥ 3 kg or ≥ 5% compared to the normal body weight), (6) perianal abscess/fistula, or (7) a family history of inflammatory bowel disease.

Who cannot join

  • Acute bowel obstruction
  • Intake of NSAIDs or acetylsalicylic acid ≤ 4 weeks before inclusion except prophylactic treatment with low dose Aspirin (≤ 150 mg per day)
  • Pregnancy or lactation
  • Alcohol or drug abuse
  • Known gastrointestinal disorder other than inflammatory bowel disease
  • Renal failure defined by a plasma-creatinine above the normal reference range
Show all 9Show fewer
  • Claustrophobia, cardiac pacemaker or implanted magnetic foreign bodies that precludes MREC
  • Interpreter required or inability to understand the oral and written information
  • Colonoscopy contraindicated, performed within 3 months or unwillingness to go through colonoscopy

Trial locations and contacts

3 sites in 1 country.

Denmark3 sites

  • Sydvestjysk sygehus

    Esbjerg, DK-6700

  • Odense university Hospital

    Odense, DK-5000

  • Sygehus Lillebaelt

    Vejle, DK-7100

Other trials in Denmark

About this study

Official title: A Comparative Study of the Diagnostic Validity of Ultrasound, Magnetic Resonance Imaging and Capsule Endoscopy of Both the Small and Large Intestine in Suspected Crohn's Disease

The purpose of this study is to determine whether Non-invasive endoscopic procedures (pillcam colon capsule endoscopy, PCCE) and non-ionizing radiological modalities (MR enterocolonography, MREC and ultrasound, US) - offer a sufficiently high diagnostic validity in patients with suspected CD compared to the traditional invasive approach using ileocolonoscopy with biopsies as first line diagnostic modality

Read the detailed description

This is a prospective, blinded, multicenter study of the diagnostic validity, inter-observer agreement, image quality and subjective experience of discomfort with PCCE, MREC and US in patients with suspected CD. Ileocolonoscopy serves as the diagnostic gold standard. Patients are recruited from 3 centers in the Region of Southern Denmark managing adult patients with inflammatory bowel diseases. Each patient goes through a standardized work-up including medical history, physical examination, C-reactive protein, fecal calprotectin, ileocolonoscopy, PCCE, MREC and US. All examinations are reviewed and described in a standardized fashion. The radiologists and physicians describing PCCE, MREC, and US are blinded to the findings at ileocolonoscopy and the other imaging modalities.

Conditions
Crohn Disease
Being tested
Diagnostic imaging
Keywords
Capsule endoscopy, Crohn's disease, Magnetic resonance enterography, Ileocolonoscopy, Bowel Ultrasound, diagnostic imaging
Medical subject headings
Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Diagnostic imagingOther

Study groups in NCT03134586
Study groupRoleWhat they receive
trial participantOtherAll participants undergoes the same diagnostic imaging
Receives: Other: Diagnostic imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sensitivity and specificity of PCCE, MREC and US for the diagnosis of CD

    Sensitivity and specificity of PCCE, MREC and US for the diagnosis of CD located in the terminal ileum and colon (per patient \& per segment). Ileocolonoscopy serves as gold standard

    Measured: 36 months

  2. Correlation of disease severity

    Correlation of disease severity assessed with PCCE, MREC, US and ileocolonoscopy

    Measured: 36 months

  3. Inter-observer agreement

    Inter-observer agreement with PCCE, MREC, US and ileocolonoscopy

    Measured: 36 months

Secondary outcomes (4)

  1. Diagnostic yield of proximal CD

    Diagnostic yield of PCCE, MREC and US for CD located proximal to the terminal ileum

    Measured: 36 months

  2. Patients reported experience

    Patients' subjective experience of discomfort during PCCE, MREC, US and ileocolonoscopy

    Measured: 36 months

  3. Interobserver PCCE

    Sensitivity and specificity of PCCE with different reading protocols

    Measured: 36 months

  4. Utility of diffusion weighed magnetic resonance imaging (dw-MREC) and US Doppler flow

    Utility of diffusion weighed magnetic resonance imaging (dw-MREC) and US Doppler flow (Limberg score): Sensitivity, specificity and correlation with endoscopic disease activity

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2017
  2. Study startJun 2016
  3. Primary completion31 Aug 2020
  4. Study completion23 Oct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
153 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03134586
Sponsor's protocol ID
ANDI 1
Acronym
ANDI
Status last verified
Oct 2022
First submitted
6 Jan 2017
Last updated
1 Nov 2022
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Brodersen JB, Jensen MD, Juel MA, Kjeldsen J, Knudsen T, Rafaelsen SR. Intestinal ultrasound in patients with suspected Crohn's disease - results of a prospective evaluation by trainees. Scand J Gastroenterol. 2023 Jul-Dec;58(12):1405-1411. doi: 10.1080/00365521.2023.2234538. Epub 2023 Jul 17.

    PubMed 37459054

  • Brodersen JB, Knudsen T, Kjeldsen J, Juel MA, Rafaelsen SR, Jensen MD. Diagnostic accuracy of pan-enteric capsule endoscopy and magnetic resonance enterocolonography in suspected Crohn's disease. United European Gastroenterol J. 2022 Nov;10(9):973-982. doi: 10.1002/ueg2.12307. Epub 2022 Sep 7.

    PubMed 36069336

Questions about this trial

What is this clinical trial studying?

A study testing Diagnostic imaging in people with Crohn Disease, run by Esbjerg Hospital - University Hospital of Southern Denmark at 3 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sensitivity and specificity of PCCE, MREC and US for the diagnosis of CD (time frame: 36 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03134586, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2022.

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