Magnetic resonance imaging (MRI) fluoroscopy for imaging childhood gastrointestinal malrotatio

Not Applicable

Completed

• Conditions: Surgery; 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; Magnetic resonance imaging (MRI)

• Registration Number: ISRCTN55042368
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07-07
• Last Update Posted: 28 August 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.