CEUS in Kidney and Pancreas Transplantation

NCT02104024 | Unknown

• 1 other identifier: HAK 1.0
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Transplantation; Pancreas Transplantation

Keywords

Kidney; Pancreas; Transplant; Contrast Enhanced Ultrasound

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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.

• Post-operative complications

  Up-to patient discharge, likely 2 weeks

Other Outcomes (1)

• Assess blood flow and morphology of the implanted pancreas

  Likely to be within 24 hours post surgery

Study Arms (2)

Kidney transplant recipients

CEUS in Kidney Transplant recipients

Other: Contrast Enhanced Ultrasound Scanning

Pancreas transplant recipients

CEUS in pancreas transplant recipients

Other: Contrast Enhanced Ultrasound Scanning

Interventions

Contrast Enhanced Ultrasound Scanning OTHER

Also known as: CEUS

Kidney transplant recipients; Pancreas transplant recipients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Kidney and pancreas transplant recipients

You may qualify if:

• adult kidney transplant recipients
• adult pancreas transplant recipients

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manchester: lead
• Manchester University NHS Foundation Trust: collaborator

Study Sites (1)

Manchester Royal Infirmary

Manchester, M13 9WL, United Kingdom

RECRUITING

Study Officials

• Hussein A Khambalia, BMedSci, BMBS, MRCS

  Manchester Royal Infirmary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hussein A Khambalia, BMBS, MRCS, BMedSci

CONTACT

00 (44) 1612761234; hussein.khambalia@cmft.nhs.uk

David van Dellen, MBBS, FRCS, MD

CONTACT

00 (44) 1612761234; david.vandellen@cmft.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical research Fellow

Study Record Dates

• First Submitted: February 12, 2014
• First Posted: April 4, 2014
• Study Start: October 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: April 4, 2014

Record last verified: 2014-04

Locations

GB (1)