Crohn's DiseaseNCT01019460
A Comparative Study of Capsule Endoscopy, Magnetic Resonance Imaging and Computer Tomography Scanning of the Small Bowel in Crohn's Disease
A study testing Magnetic resonance imaging, computed tomography scanning and capsule endoscopy in people with Crohn's Disease, run by University of Southern Denmark.
Trial summary
The aim of this study is to evaluate three diagnostic methods for assessing small bowel disease in patients with suspected or known Crohn's disease. All patients are examined with ileo-colonoscopy, capsule endoscopy, MRI and CT of the small bowel within 14 days. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Magnetic resonance imaging, computed tomography scanning and capsule endoscopy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Oct 2007to Aug 2011
- 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 criteria:
- Age > 15 years
- Written informed consent
- Patients with established CD are included if assessment of small bowel disease was necessary prior to expected surgery or a change in medical therapy.
- Patients with suspected CD are included on either clinical, endoscopical or histological criteria or a combination of these.
- Clinical criteria: Diarrhoea and/or abdominal pain for more than 1 month (or repeated episodes of diarrhoea and/or abdominal pain) associated with one or more of the following findings: CRP > 5 mg/l, thrombocytosis, anaemia, fever, weight loss, perianal abscess/fistula or a family history of inflammatory bowel disease.
- Endoscopical criteria (at least one): Ulcerations and/or stenosis in the terminal ileum, inflammation in the colon not involving the rectum, and aphthous ulcerations in the colon.
- Histological criteria (at least one): Epitheloid cell granulomas, chronic inflammation in the lamina muscularis mucosae or deeper and chronic inflammation in the colon not involving the rectum.
Who cannot join
- Acute bowel obstruction, elevated serum-creatinine, severe claustrophobia, cardiac pacemaker, implanted magnetic foreign bodies, use of NSAID's, pregnancy and lactation
About this study
The aim of this study is to evaluate three diagnostic methods for assessing small bowel disease in patients with suspected or known Crohn's disease. All patients are examined with ileo-colonoscopy, capsule endoscopy, MRI and CT of the small bowel within 14 days. However, capsule endoscopy is not performed in patients with stenosis detected at ileo-colonoscopy, MRI and/or CT. All investigations are described in a similar pre-defined and standardized fashion and the radiologist and physician responsible for describing the findings at MRI, CT and capsule endoscopy are blinded to the findings at ileo-colonoscopy. The physician in charge of treatment receives a randomised result of either MRI, CT or capsule endoscopy. Thereafter patients are followed during 12 months to evaluate differences in clinical outcome depending on the randomized result. In combination with the diagnostic validity and inter-observer agreement of MRI, CT and capsule endoscopy we seek to establish the optimal diagnostic strategy in these two patient categories.
Read the detailed description
OVERALL AIM OF THE STUDY To evaluate three diagnostic methods for assessment of intestinal disease in patients with suspected or newly diagnosed Crohn's disease and patients with known Crohn's disease.
PARTICIPATING CENTRES
- Department of Medical Gastroenterology, Odense University Hospital, DK-5000 Odense C
- Department of Internal Medicine, section of Gastroenterology, Vejle Hospital, DK-7100 Vejle
- Department of Internal Medicine, section of Gastroenterology, Sydvestjysk Hospital, DK-6700 Esbjerg
- Department of Internal Medicine, section of Gastroenterology, Svendborg Hospital, DK-5700 Svendborg
- Department of Radiology, Vejle Hospital, DK-7100 Vejle
PROTOCOL A
A comparative study of capsule endoscopy, magnetic resonance imaging and computer tomography scanning of the small bowel in patients with suspected or newly diagnosed Crohn's disease
Protocol procedures:
At inclusion all patients will have a standardised work-up including medical history, physical examination, blood and faeces samples and ileo-colonoscopy. Within two weeks MRI and CT scanning of the small intestine (on the same day and in randomised order) and subsequently CE will be performed in all patients. All investigations are described in a similar pre-defined and standardized fashion and the radiologist and physician responsible for describing the findings at MRI, CT and CE are blinded to the findings at ileo-colonoscopy and the other small bowel examinations. In the follow-up part of the study the physician in charge of the patient will be randomised to receive the results of either MRI, CT or CE.
Anticipated outcome:
The study is performed to improve evidence about what is the best primary investigation for assessment of small intestinal involvement in patients with suspected Crohn's disease, to evaluate if a combination of diagnostic modalities may improve our assessment of disease burden for the individual patients, to study whether the initial diagnostic modalities affect the handling of the patients and to study the interobserver variation of MRI and CT scanning.
PROTOCOL B
A comparative study of magnetic resonance imaging, computer tomography scanning and capsule endoscopy in patients with known Crohn's disease
Protocol procedures:
At inclusion all patients will undergo a standardised work-up including history, physical examination, blood and faeces samples and ileo-colonoscopy. Within two weeks MRI, CT scanning of the small intestine (on the same day in randomised order) and capsule endoscopy will be performed in all patients. Capsule endoscopy will not be performed in patients with small bowel stenosis confirmed at ileo-colonoscopy, MRI and/or CT. All three investigations will be described in a similar predefined standardized fashion with the radiologist blinded to the findings at ileo-colonoscopy. In the randomised part of the study the physician in charge of the patient will be randomised to receive the result of either MRI, CT og capsule endoscopy.
Anticipated outcome:
The best diagnostic method for evaluation of small intestinal involvement in patients with known Crohn's disease may be different from patients suspected of Crohn's disease. Thus in the current study we hope to provide evidence of whether MRI, CT scanning or capsule endoscopy is the best diagnostic approach.
- Conditions
- Crohn's Disease
- Being tested
- Magnetic resonance imaging, computed tomography scanning and capsule endoscopy
- Keywords
- Small intestine, Magnetic resonance imaging, Computed tomography scanning, Capsule endoscopy
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic resonance imaging, computed tomography scanning and capsule endoscopyProcedure or surgery
All patients are examined with ileo-colonoscopy, capsule endoscopy, MRI and CT of the small bowel within 14 days. Capsule endoscopy will not be performed in patients with small bowel stenosis confirmed at ileo-colonoscopy, MRI and/or CT.
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity for CT scanning of the small bowel, MRI of the small bowel and CE.
Measured: February 2010
Secondary outcomes (1)
Interobserver variation for capsule endoscopy, MRI and CT scanning of the small intestine Patient experienced discomfort
Measured: February 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2009 (estimated)
- Study startOct 2007
- Primary completionOct 2010
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital
- Responsible party
- Principal investigator, Michael Dam Jensen, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01019460
- Sponsor's protocol ID
- S-20070072
- Status last verified
- Sep 2011
- First submitted
- 24 Nov 2009
- Last updated
- 21 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jensen MD, Andersen RF, Christensen H, Nathan T, Kjeldsen J, Madsen JS. Circulating microRNAs as biomarkers of adult Crohn's disease. Eur J Gastroenterol Hepatol. 2015 Sep;27(9):1038-44. doi: 10.1097/MEG.0000000000000430.
PubMed 26230660Jensen MD, Nathan T, Rafaelsen SR, Kjeldsen J. Ileoscopy reduces the need for small bowel imaging in suspected Crohn's disease. Dan Med J. 2012 Sep;59(9):A4491.
PubMed 22951194
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Capsule Endoscopy, Magnetic Resonance Imaging and Computer Tomography Scanning of the Small Bowel in Crohn's Disease
- ClinicalTrials.gov ID
- NCT01019460
- Acronym / sponsor ID
- S-20070072
- Conditions
- Crohn's Disease
- Keywords
- Small intestine, Magnetic resonance imaging, Computed tomography scanning, Capsule endoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Odense University Hospital
- Study start
- Oct 2007
- Primary completion
- Oct 2010 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 25 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate three diagnostic methods for assessing small bowel disease in patients with suspected or known Crohn's disease. All patients are examined with ileo-colonoscopy, capsule endoscopy, MRI and CT of the small bowel within 14 days. However, capsule endoscopy is not performed in patients with stenosis detected at ileo-colonoscopy, MRI and/or CT. All investigations are described in a similar pre-defined and standardized fashion and the radiologist and physician responsible for describing the findings at MRI, CT and capsule endoscopy are blinded to the findings at ileo-colonoscopy. The physician in charge of treatment receives a randomised result of either MRI, CT or capsule endoscopy. Thereafter patients are followed during 12 months to evaluate differences in clinical outcome depending on the randomized result. In combination with the diagnostic validity and inter-observer agreement of MRI, CT and capsule endoscopy we seek to establish the optimal diagnostic strategy in these two patient categories.
Detailed description
OVERALL AIM OF THE STUDY To evaluate three diagnostic methods for assessment of intestinal disease in patients with suspected or newly diagnosed Crohn's disease and patients with known Crohn's disease.
PARTICIPATING CENTRES
- Department of Medical Gastroenterology, Odense University Hospital, DK-5000 Odense C
- Department of Internal Medicine, section of Gastroenterology, Vejle Hospital, DK-7100 Vejle
- Department of Internal Medicine, section of Gastroenterology, Sydvestjysk Hospital, DK-6700 Esbjerg
- Department of Internal Medicine, section of Gastroenterology, Svendborg Hospital, DK-5700 Svendborg
- Department of Radiology, Vejle Hospital, DK-7100 Vejle
PROTOCOL A
A comparative study of capsule endoscopy, magnetic resonance imaging and computer tomography scanning of the small bowel in patients with suspected or newly diagnosed Crohn's disease
Protocol procedures:
At inclusion all patients will have a standardised work-up including medical history, physical examination, blood and faeces samples and ileo-colonoscopy. Within two weeks MRI and CT scanning of the small intestine (on the same day and in randomised order) and subsequently CE will be performed in all patients. All investigations are described in a similar pre-defined and standardized fashion and the radiologist and physician responsible for describing the findings at MRI, CT and CE are blinded to the findings at ileo-colonoscopy and the other small bowel examinations. In the follow-up part of the study the physician in charge of the patient will be randomised to receive the results of either MRI, CT or CE.
Anticipated outcome:
The study is performed to improve evidence about what is the best primary investigation for assessment of small intestinal involvement in patients with suspected Crohn's disease, to evaluate if a combination of diagnostic modalities may improve our assessment of disease burden for the individual patients, to study whether the initial diagnostic modalities affect the handling of the patients and to study the interobserver variation of MRI and CT scanning.
PROTOCOL B
A comparative study of magnetic resonance imaging, computer tomography scanning and capsule endoscopy in patients with known Crohn's disease
Protocol procedures:
At inclusion all patients will undergo a standardised work-up including history, physical examination, blood and faeces samples and ileo-colonoscopy. Within two weeks MRI, CT scanning of the small intestine (on the same day in randomised order) and capsule endoscopy will be performed in all patients. Capsule endoscopy will not be performed in patients with small bowel stenosis confirmed at ileo-colonoscopy, MRI and/or CT. All three investigations will be described in a similar predefined standardized fashion with the radiologist blinded to the findings at ileo-colonoscopy. In the randomised part of the study the physician in charge of the patient will be randomised to receive the result of either MRI, CT og capsule endoscopy.
Anticipated outcome:
The best diagnostic method for evaluation of small intestinal involvement in patients with known Crohn's disease may be different from patients suspected of Crohn's disease. Thus in the current study we hope to provide evidence of whether MRI, CT scanning or capsule endoscopy is the best diagnostic approach.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Age > 15 years
- Written informed consent
- Patients with established CD are included if assessment of small bowel disease was necessary prior to expected surgery or a change in medical therapy.
- Patients with suspected CD are included on either clinical, endoscopical or histological criteria or a combination of these.
- Clinical criteria: Diarrhoea and/or abdominal pain for more than 1 month (or repeated episodes of diarrhoea and/or abdominal pain) associated with one or more of the following findings: CRP > 5 mg/l, thrombocytosis, anaemia, fever, weight loss, perianal abscess/fistula or a family history of inflammatory bowel disease.
Key exclusion criteria (1 listed)
- Acute bowel obstruction, elevated serum-creatinine, severe claustrophobia, cardiac pacemaker, implanted magnetic foreign bodies, use of NSAID's, pregnancy and lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic resonance imaging, computed tomography scanning and capsule endoscopyAll patients are examined with ileo-colonoscopy, capsule endoscopy, MRI and CT of the small bowel within 14 days. Capsule endoscopy will not be performed in patients with small bowel stenosis confirmed at ileo-colonoscopy, MRI and/or CT. | Procedure or surgery | – |
Primary outcome
Sensitivity and specificity for CT scanning of the small bowel, MRI of the small bowel and CE.
Time frame: February 2010
1 secondary outcome
Interobserver variation for capsule endoscopy, MRI and CT scanning of the small intestine Patient experienced discomfort
Time frame: February 2010
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2011.
- Derived from this study: PubMed 26230660Jensen MD, Andersen RF, Christensen H, Nathan T, Kjeldsen J, Madsen JS. Circulating microRNAs as biomarkers of adult Crohn's disease. Eur J Gastroenterol Hepatol. 2015 Sep;27(9):1038-44. doi: 10.1097/MEG.0000000000000430.
- Derived from this study: PubMed 22951194Jensen MD, Nathan T, Rafaelsen SR, Kjeldsen J. Ileoscopy reduces the need for small bowel imaging in suspected Crohn's disease. Dan Med J. 2012 Sep;59(9):A4491.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic resonance imaging, computed tomography scanning and capsule endoscopy in people with Crohn's Disease, run by University of Southern 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 1 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 21 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
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 for CT scanning of the small bowel, MRI of the small bowel and CE. (time frame: February 2010). 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 NCT01019460, 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 21 Sep 2011.