Clinical trial NCT02104024: CEUS in Kidney and Pancreas Transplantation
Official title: Contrast Enhanced Ultrasound Scanning of Kidney and Pancreas Transplantation (Proof of Principle Study)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Kidney Transplantation
Pancreas Transplantation
Keywords: Kidney
Pancreas
Transplant
Contrast Enhanced Ultrasound
Lead sponsor: University of Manchester
Sponsor class: OTHER
Collaborators: name: Manchester University NHS Foundation Trust
First posted: 2014-04-04
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Kidney and pancreas transplant recipients

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: To ensure feasibility of conducting CEUS post renal and pancreas transplantation
timeFrame: Likely to be 24 hours post surgery.
measure: To assess patient acceptability of performing CEUS in the peri-operative period
timeFrame: Likely to be within 24 hours post surgery
Secondary outcomes:
measure: Compare the quantification (likely expressed as percentage) of organ perfusion from CEUS, with our current gold standard, the nuclear renogram.
timeFrame: Once both, renogram and CEUS have been performed. Likely to be within 24 hours of surgery.
measure: Post-operative complications
timeFrame: Up-to patient discharge, likely 2 weeks
Other outcomes:
measure: Assess blood flow and morphology of the implanted pancreas
timeFrame: Likely to be within 24 hours post surgery
Locations:
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary
Study officials:
affiliation: Manchester Royal Infirmary
name: Hussein A Khambalia, BMedSci, BMBS, MRCS
role: PRINCIPAL_INVESTIGATOR
References: