CEUS in Kidney and Pancreas Transplantation

NCT ID: NCT02104024

Last Updated: 2014-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

65 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Kidney Transplantation Pancreas Transplantation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Kidney transplant recipients

CEUS in Kidney Transplant recipients

Contrast Enhanced Ultrasound Scanning

Intervention Type OTHER

Pancreas transplant recipients

CEUS in pancreas transplant recipients

Contrast Enhanced Ultrasound Scanning

Intervention Type OTHER

Interventions

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Contrast Enhanced Ultrasound Scanning

Intervention Type OTHER

Other Intervention Names

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CEUS

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Manchester University NHS Foundation Trust

OTHER_GOV

Sponsor Role collaborator

University of Manchester

OTHER

Sponsor Role lead

Responsible Party

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Hussein Khambalia

Clinical research Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hussein A Khambalia, BMedSci, BMBS, MRCS

Role: PRINCIPAL_INVESTIGATOR

Manchester Royal Infirmary

Locations

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Manchester Royal Infirmary

Manchester, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Hussein A Khambalia, BMBS, MRCS, BMedSci

Role: CONTACT

00 (44) 1612761234

David van Dellen, MBBS, FRCS, MD

Role: CONTACT

00 (44) 1612761234

Facility Contacts

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Khambalia

Role: primary

Other Identifiers

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HAK 1.0

Identifier Type: -

Identifier Source: org_study_id

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