Advanced Non-Invasive Diagnostics in Inflammatory Bowel Disease

NCT03134586 | Completed

• 1 other identifier: ANDI 1
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 3

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

Conditions

Crohn Disease

Keywords

Capsule endoscopy; Crohn's disease; Magnetic resonance enterography; Ileocolonoscopy; Bowel Ultrasound; diagnostic imaging

Outcome Measures

Primary Outcomes (3)

• 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

  36 months

• Correlation of disease severity

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

  36 months

• Inter-observer agreement

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

  36 months

Secondary Outcomes (4)

• Diagnostic yield of proximal CD

  36 months

• Patients reported experience

  36 months

• Interobserver PCCE

  36 months

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

  36 months

Study Arms (1)

trial participant

OTHER

All participants undergoes the same diagnostic imaging

Other: Diagnostic imaging

Interventions

Diagnostic imaging OTHER

trial participant

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Acute bowel obstruction
• 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

Sponsors & Collaborators

• Esbjerg Hospital - University Hospital of Southern Denmark: lead
• Odense University Hospital: collaborator
• Sygehus Lillebaelt: collaborator

Study Sites (3)

Sydvestjysk sygehus

Esbjerg, DK-6700, Denmark

Location

Odense university Hospital

Odense, DK-5000, Denmark

Location

Sygehus Lillebaelt

Vejle, DK-7100, Denmark

Location

Related Publications (2)

• 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.

  PMID: 37459054 DERIVED

• 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.

  PMID: 36069336 DERIVED

MeSH Terms

Conditions

Crohn Disease

Interventions

X-Rays

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Officials

• Jacob B Brodersen, MD

  Esbjerg Hospital - University Hospital of Southern Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist Registrat

Study Record Dates

• First Submitted: January 6, 2017
• First Posted: May 1, 2017
• Study Start: June 1, 2016
• Primary Completion: August 31, 2020
• Study Completion: October 23, 2020
• Last Updated: November 1, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (3)