Feasibility Study of a New Magnetic Resonance Imaging Mini-capsule Device to Measure Whole Gut Transit Time in Paediatric Constipation

Abstract

Objective: In England, 27,500 children are referred annually to hospital with constipation. An objective measure of whole gut transit time (WGTT) could aid management. The current standard WGTT assessment, the x-ray radiopaque marker (ROM) test, gives poor definition of colonic anatomy and the radiation dose required is undesirable in children. Our objective was to develop an alternative magnetic resonance imaging (MRI) WGTT measure to the x-ray ROM test and to demonstrate its initial feasibility in paediatric constipation. Methods: With the Nottingham Young Person's Advisory Group we developed a small (8 × 4 mm), inert polypropylene capsule shell filled with MRI-visible fat emulsion. The capsule can be imaged using MRI fat and water in-phase and out-of-phase imaging. Sixteen patients with constipation and 19 healthy participants aged 7 to 18 years old were recruited. Following a common ROM protocol, the participants swallowed 24 mini-capsules each day for 3 days and were imaged on days 4 and 7 using MRI. The number of successful studies (feasibility) and WGTT were assessed. Participants’ EuroQoL Visual Analogue Scale were also collected and compared between the day before the taking the first set of mini-capsules to the day after the last MRI study day. Results: The mini-capsules were imaged successfully in the colon of all participants. The WGTT was 78 ± 35 hours (mean ± standard deviation) for patients, and 36 ± 16 hours, P < 0.0001 for healthy controls. Carrying out the procedures did not change the EuroQoL Visual Analogue Scale scores before and after the procedures. Conclusions: Magnetic Resonance Imaging in Paediatric Constipation was a first-in-child feasibility study of a new medical device to measure WGTT in paediatric constipation using MRI. The study showed that the new method is feasible and is well tolerated.

Colonic Volume Changes in Paediatric Constipation Compared to Normal Values Measured Using MRI

“…The data for this retrospective study are from a previous MRI study investigating WGTT [24]. Participants had to be between the ages of 7 and 18 years old.…”

“…The formula calculates BSA as the square root of (height (cm) × weight (kg)/3600). Linear regression was used to explore the relationship between total colon volume from this study and the individual participants' WGTT values from [24].…”

“…Therefore, the primary aim of this study was to measure colonic volume in children with FC and also provide initial normal range values for healthy controls. We used MRI images from a recently published study that measured whole gut transit time (WGTT) [24], which also allowed us to consider possible correlation of the new colonic volume data with WGTT as the secondary aim of this study.…”

“A little (PPI) MAGIC can take you a long way” : involving children and young people in research from inception of a novel medical device to multi-centre clinical trial Roald Dahl, James and the Giant Peach (1961)

“…A poster co-authored by the YPAG was also presented at the British Paediatric Gastroenterologist Conference as well as a subsequent Nottingham Paediatric Research Showcase. Lastly, the YPAG contributed and are formal co-authors on the scientific paper originating from the MAGIC feasibility clinical study [1] and of course on this Commentary.…”

“…The project is funded by the NIHR with GenerationR Alliance supporting the design and delivery of paediatric health research in the UK. The MAGIC study findings have been recently published in a separate manuscript which details the design of the new mini-capsules device and the scientific details of the feasibility clinical study [1]. The main features of the MAGIC study are summarised in Table 1.…”