CEUS in Kidney and Pancreas Transplantation

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

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.

Study Overview

• Status: Unknown
• Conditions: Kidney Transplantation; Pancreas Transplantation
• Intervention / Treatment: Other: Contrast Enhanced Ultrasound Scanning

• Study Type: Observational
• Enrollment (Anticipated): 65

Contacts and Locations

Study Locations

• United Kingdom
  • Manchester, United Kingdom, M13 9WL
    • Recruiting
    • Manchester Royal Infirmary
    • Contact: Khambalia; Email: hussein.khambalia@cmft.nhs.uk
    • Principal Investigator: Hussein A Khambalia, BMBS, BMedSci, MRCS
    • Principal Investigator: David van Dellen, MBBS, FRCS, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Kidney and pancreas transplant recipients

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Kidney transplant recipients; CEUS in Kidney Transplant recipients	Other: Contrast Enhanced Ultrasound Scanning; Other Names: CEUS
Pancreas transplant recipients; CEUS in pancreas transplant recipients	Other: Contrast Enhanced Ultrasound Scanning; Other Names: CEUS

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Manchester
• Collaborators: Manchester University NHS Foundation Trust
• Investigators: Principal Investigator: Hussein A Khambalia, BMedSci, BMBS, MRCS, Manchester Royal Infirmary

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (ANTICIPATED): September 1, 2014
• Study Completion (ANTICIPATED): September 1, 2014

Study Registration Dates

• First Submitted: February 12, 2014
• First Submitted That Met QC Criteria: April 3, 2014
• First Posted (ESTIMATE): April 4, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): April 4, 2014
• Last Update Submitted That Met QC Criteria: April 3, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Pancreas; Transplant; Kidney; Contrast Enhanced Ultrasound
• Other Study ID Numbers: HAK 1.0