CEUS in Kidney and Pancreas Transplantation

Study Overview
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Brief Summary
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This study is to investigate whether it is possible to use a special type of ultrasound scan (CEUS, Contrast Enhanced Ultrasound Scan) to view the shape, assess blood supply and calculate the amount of oxygen being carried to a transplanted kidney and pancreas. We currently use a nuclear scan (Transcan) to assess this in the kidney. This is cumbersome, involves nuclear medicine and takes 45- 60 minutes to complete. We do not routinely image the blood supply to the pancreas post-surgery, despite the most common complication post pancreas transplantation being vascular in origin. In an emergency a CT angiogram is carried out. This involves transfer of a sick patient to the CT scanner and injection of contrast which is harmful to the kidneys. CEUS involves injection of a safe contrast prior to conducting an ultrasound scan. This can be carried out at the bed-side, provides instant results and is cheap and safe enough to do on a routine basis for all kidney and pancreas transplant recipients. Although the uses of CEUS are well recognised, it is currently not routinely used in transplantation. CEUS has been compared to other modes of imaging and has been found to be comparable/ beneficial. However, it has never been compared to Transcan. We will therefore perform CEUS on our kidney transplant recipients and compare the results to Transcan. We will also assess whether CEUS is able to visualise the blood supply to the kidney and pancreas and quantify the perfusion to the pancreas.

Official Title
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Contrast Enhanced Ultrasound Scanning of Kidney and Pancreas Transplantation (Proof of Principle Study)

Conditions
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Kidney Transplantation, Pancreas Transplantation

Intervention / Treatment
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* Other: Contrast Enhanced Ultrasound Scanning


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult kidney transplant recipients adult pancreas transplant recipients Exclusion Criteria: patients unable to consent to the study patients under the age of 18 patients with an absolute or relative contra-indication to receiving SonoVue contrast serious intra-operative complication

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Kidney transplant recipients<br>CEUS in Kidney Transplant recipients | Other: Contrast Enhanced Ultrasound Scanning<br> <br> * Other names: CEUS;|
| Pancreas transplant recipients<br>CEUS in pancreas transplant recipients | Other: Contrast Enhanced Ultrasound Scanning<br> <br> * Other names: CEUS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To ensure feasibility of conducting CEUS post renal and pancreas transplantation | To ensure that conducting CEUS in the peri-operative period is logistically feasible in our centre at short-notice and it is possible to obtain images which are usable for analysis, given the presence of dressings and drains on the abdomen post surgery. | Likely to be 24 hours post surgery. | 
| To assess patient acceptability of performing CEUS in the peri-operative period | A validated pain questionnaire will be completed by the patient, assessing pain scores prior to and after the CEUS, compared to prior to and after the renogram. | Likely to be within 24 hours post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the quantification (likely expressed as percentage) of organ perfusion from CEUS, with our current gold standard, the nuclear renogram. | The quantification analysis of the CEUS and renograms will be correlated using descriptive statistics and either parametric or non-parametric statistical analysis to produce a correlation coefficient. | Once both, renogram and CEUS have been performed. Likely to be within 24 hours of surgery. | 
| Post-operative complications | A note of all post-operative complications, up-to discharge will be assessed. | Up-to patient discharge, likely 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kidney, Pancreas, Transplant, Contrast Enhanced Ultrasound