Magnetic resonance imaging (MRI) fluoroscopy for imaging childhood gastrointestinal malrotation
| ISRCTN | ISRCTN55042368 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55042368 |
| Secondary identifying numbers | 6144; G0800411 |
- Submission date
- 07/07/2010
- Registration date
- 07/07/2010
- Last edited
- 27/07/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Ms Wendy Phillips
Scientific
Scientific
Radiology, Box 162
Hills Road
Cambridge
CB2 0QQ
United Kingdom
| wendyphillips@addenbrookes.nhs.uk |
Study information
| Study design | Single-centre non-randomised observational diagnosis and validation of investigative process trial |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Magnetic resonance imaging (MRI) replacement of x-ray fluoroscopy in paediatric imaging: an investigation of gastrointestinal malrotation |
| Study objectives | The aim of this study is to develop rapid magnetic resonance imaging (MRI) techniques which will replace X-ray fluoroscopy methodology for diagnostic imaging in children with suspected gastrointestinal abnormalities (e.g., gut malrotation). This project has two parts: 1. The aim is to optimise the MRI environment for small children, including patient handling, communication, nursing and parental support requirements, and refinement of MR protocols, with direct parent feedback. 2. A diagnostic performance trial will then be conducted, a non-randomised feasibility trial comparing the established X-ray investigation with the optimised MR investigation in children with suspected gut abnormalities, to ensure that MRI is as good, if not better than, X-ray testing. |
| Ethics approval(s) | Cambridgeshire 3 Research Ethics Committee, 15/04/2008, ref: 08/H0306/7 |
| Health condition(s) or problem(s) studied | Topic: Oral and Gastrointestinal, Generic Health Relevance and Cross Cutting Themes; Subtopic: Oral and Gastrointestinal (all Subtopics), Generic Health Relevance (all Subtopics); Disease: Gastrointestinal, Paediatrics |
| Intervention | All patients volunteering for this study will undergo the conventional XR fluoroscopy examination as per standard practice, followed by an additional MRI examination. The diagnosis of the XR test will be known, in order to select the patients most appropriate for MR examination. However, the MRI examination will be reported by a radiologist blinded to the diagnosis made on X-ray. As the presence or absence of gut malrotation is a stable diagnosis, the confirmation of its presence on the X-ray test is unlikely to affect the MRI test. Data collection involves completion of demographic proformas, parent questionnaires, and real-time acquisition of radiological images which will be assessed and stored for retrospective analysis. The two examinations are expected to take place on the same day. The conventional X-ray studies will be reported immediately following normal practice to allow for immediate clinical management. In each case the person supervising and reporting the respective studies will not be aware of the results of the other investigation. Upper gastrointestinal studies will be reported for the presence/absence of the duodeno-jejunal flexure in the correct anatomical location, and for any other duodenal or jejunal abnormalities. There is no follow-up as part of the study, but patients will be treated as per standard practice on the basis of the XR fluoroscopy results. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Can a technique using magnetic resonance MR fluoroscopy be developed to replace the conventional X-ray fluoroscopy methodology? All outcomes will be assessed at the time of the intervention. |
| Secondary outcome measures | To demonstrate the feasibility of magnetic resonance imaging for this type of paediatric imaging, including an assessment of its technical and diagnostic performance, by direct comparison with the established X-ray fluoroscopy based techniques. After each participant has their MRI scan, the results will be compared with those obtained with the standard X-ray fluoroscopy technique, and scored for sensitivity and accuracy in diagnosing gut malrotation. All outcomes will be assessed at the time of the intervention. |
| Overall study start date | 01/11/2008 |
| Completion date | 01/09/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 0 Years |
| Upper age limit | 6 Years |
| Sex | Both |
| Target number of participants | Planned sample size: 50 |
| Key inclusion criteria | 1. All children between the ages of 0 and 6 years referred for an upper gut XRF contrast study for suspected upper intestinal obstruction, i.e., malrotation 2. Age range: 1 day to 6 years, male and female |
| Key exclusion criteria | 1. Usual MR exclusion criteria will apply, but are highly unlikely in this young age group. They include pregnancy, claustrophobia, cardiac pacemakers, metallic implants, cardiac defibrillator implants, aneurysm clips or metallic heart valves, and cochlear or inner ear implants. These exclusion criteria would apply to all people within the vicinity of the MRI scanner, e.g., the parents/guardians in this study. 2. Previous reaction to the relevant X-ray or MRI contrast media (including gadolinium) 3. Congenital abnormalities that make X-ray fluoroscopy or MR fluoroscopy impractical |
| Date of first enrolment | 01/11/2008 |
| Date of final enrolment | 01/09/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Addenbrookes Hospital
Cambridge
CB2 0QQ
United Kingdom
CB2 0QQ
United Kingdom
Sponsor information
Cambridge University Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
England
United Kingdom
| Website | http://www.cuh.org.uk/addenbrookes/addenbrookes_index.html |
|---|---|
"ROR" |
https://ror.org/04v54gj93 |
Funders
Funder type
Research council
Medical Research Council Clinical Research Training Fellowship (MRC CRTF) (UK) - Royal College of Radiologists (ref: G0800411)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Wendy Phillips (wendyphillips@addenbrookes.nhs.uk). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 22/09/2014 | Yes | No |
Editorial Notes
27/07/2017: IPD sharing statement and publication reference added.
