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CEUS in Kidney and Pancreas Transplantation

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02104024
Enrollment
65
Registered
2014-04-04
Start date
2013-10-31
Completion date
2014-09-30
Last updated
2014-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplantation, Pancreas Transplantation

Keywords

Kidney, Pancreas, Transplant, Contrast Enhanced Ultrasound

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.

Interventions

OTHERContrast Enhanced Ultrasound Scanning

Sponsors

Manchester University NHS Foundation Trust
CollaboratorOTHER_GOV
University of Manchester
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
To ensure feasibility of conducting CEUS post renal and pancreas transplantationLikely to be 24 hours post surgery.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.
To assess patient acceptability of performing CEUS in the peri-operative periodLikely to be within 24 hours post surgeryA 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.

Secondary

MeasureTime frameDescription
Compare the quantification (likely expressed as percentage) of organ perfusion from CEUS, with our current gold standard, the nuclear renogram.Once both, renogram and CEUS have been performed. Likely to be within 24 hours of surgery.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.
Post-operative complicationsUp-to patient discharge, likely 2 weeksA note of all post-operative complications, up-to discharge will be assessed.

Other

MeasureTime frameDescription
Assess blood flow and morphology of the implanted pancreasLikely to be within 24 hours post surgeryDescriptive analysis of vasculature and morphology of the implanted pancreata, high-lighting potential cause of concerns eg. thrombus, bleeding, collections

Countries

United Kingdom

Contacts

Primary ContactHussein A Khambalia, BMBS, MRCS, BMedSci
hussein.khambalia@cmft.nhs.uk00 (44) 1612761234
Backup ContactDavid van Dellen, MBBS, FRCS, MD
david.vandellen@cmft.nhs.uk00 (44) 1612761234

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026