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

Primary Purpose

Crohn Disease

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Diagnostic imaging

About this trial

This is an interventional diagnostic trial for Crohn Disease focused on measuring Capsule endoscopy, Crohn's disease, Magnetic resonance enterography, Ileocolonoscopy, Bowel Ultrasound, diagnostic imaging

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Sydvestjysk sygehus
Odense university Hospital
Sygehus Lillebaelt

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

trial participant

Arm Description

All participants undergoes the same diagnostic imaging

Outcomes

Primary Outcome Measures

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

Correlation of disease severity

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

Inter-observer agreement

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

Secondary Outcome Measures

Diagnostic yield of proximal CD

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

Patients reported experience

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

Interobserver PCCE

Sensitivity and specificity of PCCE with different reading protocols

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

Full Information

NCT ID

NCT03134586

First Posted

January 6, 2017

Last Updated

October 31, 2022

Sponsor

Hospital of South West Jutland

Collaborators

Odense University Hospital, Sygehus Lillebaelt

1. Study Identification

Unique Protocol Identification Number

NCT03134586

Brief Title

Advanced Non-Invasive Diagnostics in Inflammatory Bowel Disease

Acronym

ANDI

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 Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Completed

Study Start Date

June 2016 (Actual)

Primary Completion Date

August 31, 2020 (Actual)

Study Completion Date

October 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hospital of South West Jutland

Collaborators

Odense University Hospital, Sygehus Lillebaelt

4. Oversight

Data Monitoring Committee

5. Study Description

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Crohn Disease

Keywords

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

153 (Actual)

8. Arms, Groups, and Interventions

Arm Title

trial participant

Arm Type

Other

Arm Description

All participants undergoes the same diagnostic imaging

Intervention Type

Other

Intervention Name(s)

Diagnostic imaging

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

36 months

Title

Correlation of disease severity

Description

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

Time Frame

36 months

Title

Inter-observer agreement

Description

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

Time Frame

36 months

Secondary Outcome Measure Information:

Title

Diagnostic yield of proximal CD

Description

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

Time Frame

36 months

Title

Patients reported experience

Description

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

Time Frame

36 months

Title

Interobserver PCCE

Description

Sensitivity and specificity of PCCE with different reading protocols

Time Frame

36 months

Title

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

Description

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

Time Frame

36 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jacob B Brodersen, MD

Organizational Affiliation

Hospital of South West Jutland

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sydvestjysk sygehus

City

Esbjerg

ZIP/Postal Code

DK-6700

Country

Denmark

Facility Name

Odense university Hospital

City

Odense

ZIP/Postal Code

DK-5000

Country

Denmark

Facility Name

Sygehus Lillebaelt

City

Vejle

ZIP/Postal Code

DK-7100

Country

Denmark

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

36069336

Citation

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.

Results Reference

derived

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Advanced Non-Invasive Diagnostics in Inflammatory Bowel Disease

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