CEUS in Kidney and Pancreas Transplantation

Kidney Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02104024
• Other study ID #: HAK 1.0
• Status: Recruiting
• Phase: N/A
• First received: February 12, 2014
• Last updated: April 3, 2014
• Start date: October 2013
• Est. completion date: September 2014

Study information

• Verified date: April 2014
• Source: University of Manchester
• Contact: Hussein A Khambalia, BMBS, MRCS, BMedSci
• Phone: 00 (44) 1612761234
• Email: hussein.khambalia[@]cmft.nhs.uk
• Is FDA regulated: No
• Health authority: UK: National Research ethics ServiceUK: Central Manchester University Hospitals NHS Trust, Research Office
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 65
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Kidney Transplantation
• Pancreas Transplantation

Intervention

Other:
• Contrast Enhanced Ultrasound Scanning

Locations

Country	Name	City	State
United Kingdom	Manchester Royal Infirmary	Manchester

Sponsors (2)

Lead Sponsor	Collaborator
University of Manchester	Central Manchester University Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Assess blood flow and morphology of the implanted pancreas	Descriptive analysis of vasculature and morphology of the implanted pancreata, high-lighting potential cause of concerns eg. thrombus, bleeding, collections	Likely to be within 24 hours post surgery	No
Primary	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.	No
Primary	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	No
Secondary	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.	No
Secondary	Post-operative complications	A note of all post-operative complications, up-to discharge will be assessed.	Up-to patient discharge, likely 2 weeks	No