Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Advanced Non-Invasive Diagnostics in Inflammatory Bowel Disease (ANDI)

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 evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03134586
Recruitment Status : Recruiting
First Posted : May 1, 2017
Last Update Posted : October 30, 2019
Sponsor:
Collaborators:
Odense University Hospital
Sygehus Lillebaelt
Information provided by (Responsible Party):
Jacob Brodersen, Sydvestjysk Hospital

Brief 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 traditional invasive approach using ileocolonoscopy with biopsies as first line diagnostic modality

Condition or disease Intervention/treatment Phase
Crohn Disease Other: Diagnostic imaging Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Study Start Date : June 2016
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
trial participant
All participants undergoes the same diagnostic imaging
Other: Diagnostic imaging



Primary Outcome Measures :
  1. Sensitivity and specificity of PCCE, MREC and US for the diagnosis of CD [ Time Frame: 36 months ]
    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

  2. Correlation of disease severity [ Time Frame: 36 months ]
    Correlation of disease severity assessed with PCCE, MREC, US and ileocolonoscopy

  3. Inter-observer agreement [ Time Frame: 36 months ]
    Inter-observer agreement with PCCE, MREC, US and ileocolonoscopy


Secondary Outcome Measures :
  1. Diagnostic yield of proximal CD [ Time Frame: 36 months ]
    Diagnostic yield of PCCE, MREC and US for CD located proximal to the terminal ileum

  2. Patients reported experience [ Time Frame: 36 months ]
    Patients' subjective experience of discomfort during PCCE, MREC, US and ileocolonoscopy

  3. Interobserver PCCE [ Time Frame: 36 months ]
    Sensitivity and specificity of PCCE with different reading protocols

  4. Utility of diffusion weighed magnetic resonance imaging (dw-MREC) and US Doppler flow [ Time Frame: 36 months ]
    Utility of diffusion weighed magnetic resonance imaging (dw-MREC) and US Doppler flow (Limberg score): Sensitivity, specificity and correlation with endoscopic disease activity



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03134586


Contacts
Layout table for location contacts
Contact: Jacob B Brodersen, MD +45 21298001 jacob.broder.brodersen@rsyd.dk
Contact: Michael D Jensen, MD PhD

Locations
Layout table for location information
Denmark
Sydvestjysk sygehus Recruiting
Esbjerg, Denmark, DK-6700
Contact: Jacob B Brodersen, MD       jacob.broder.brodersen@rsyd.dk   
Odense university Hospital Recruiting
Odense, Denmark, DK-5000
Contact: Jens Kjeldsen, MD, PhD         
Sygehus Lillebaelt Recruiting
Vejle, Denmark, DK-7100
Contact: Michael D Jensen, MD, PhD         
Sponsors and Collaborators
Sydvestjysk Hospital
Odense University Hospital
Sygehus Lillebaelt
Investigators
Layout table for investigator information
Principal Investigator: Jacob B Brodersen, MD Sydvestjysk Hospital

Layout table for additonal information
Responsible Party: Jacob Brodersen, Specialist Registrat, Sydvestjysk Hospital
ClinicalTrials.gov Identifier: NCT03134586    
Other Study ID Numbers: ANDI 1
First Posted: May 1, 2017    Key Record Dates
Last Update Posted: October 30, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Jacob Brodersen, Sydvestjysk Hospital:
Capsule endoscopy
Crohn's disease
Magnetic resonance enterography
Ileocolonoscopy
Bowel Ultrasound
diagnostic imaging
Additional relevant MeSH terms:
Layout table for MeSH terms
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases