UNITE: ULTRASOUND IN INTESTINAL TRANSPLANT RECIPIENTS
Research type
Research Study
Full title
UNITE: ULTRASOUND IN INTESTINAL TRANSPLANT RECIPIENTS A prospective observational study to evaluate the usefulness of ultrasound in detecting immunological complications after intestinal transplantation.
IRAS ID
249162
Contact name
Sara S Upponi
Contact email
Clinicaltrials.gov Identifier
A094923, CUHNFT R&D Reference
Duration of Study in the UK
4 years, 3 months, 31 days
Research summary
Short- term survival after intestinal transplantation has continuously improved over the past decade. Unfortunately, long term survival remains a challenge and immunological complications are still common and often result in a fatal outcome. The reason for the poor result that we experience in this cohort might be associated with the inability to diagnose complications as they arise. Currently, the mainstay of surveillance consists of frequent endoscopies. This approach is not without controversy and the need for further investigations is apparent. Endoscopy with biopsies is an invasive procedure and complications with abdominal pain, pseudo obstruction and profuse bleeding are not uncommon.
Unfortunately, not many studies have been published using alternative approaches. The experience from Gastro Intestinal Ultra Sound (GIUS) is therefore primarily derived from the IBD cohort where it has been shown to be non-invasive, cost-effective and a reproducible technique. Since 2014, GIUS has been performed at CUHNFT as a clinical tool to detect various complications, primarily, acute cellular rejection. Our experience (never published) has shown us that GIUS is of value in this cohort and offers a complete visualisation of the entire intestinal tract. Although promising, these results needs to be validated in a controlled setting. Therefore, the care team aim to perform a retrospective review using anonymised data of patients who have undergone GIUS from 2014 to now (40 GIUS investigations), followed by a prospective study of patients between 2018 to 2022 ( Hoping to recruit enough participants to analyse 100 GIUS investigations).
All patients in this prospective observational trial will receive an index examination day 3-7 after their transplantation, thereafter whenever clinically indicated. The analysis of the GIUS will be compared with the biopsies and endoscopies that all patients will continue to receive as standard care.Ultimately, we do hope that this study will facilitate an evidence-based background for the systematic use of GIUS and hopefully this might result in an earlier detection of immunological complications and thereby an improved outcome.
REC name
East of Scotland Research Ethics Service REC 2
REC reference
18/ES/0129
Date of REC Opinion
22 Nov 2018
REC opinion
Further Information Favourable Opinion