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CEUS in Kidney and Pancreas Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02104024
Recruitment Status : Unknown
Verified April 2014 by Hussein Khambalia, University of Manchester.
Recruitment status was:  Recruiting
First Posted : April 4, 2014
Last Update Posted : April 4, 2014
Sponsor:
Collaborator:
Manchester University NHS Foundation Trust
Information provided by (Responsible Party):
Hussein Khambalia, University of Manchester

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.


Condition or disease Intervention/treatment
Kidney Transplantation Pancreas Transplantation Other: Contrast Enhanced Ultrasound Scanning

Layout table for study information
Study Type : Observational
Estimated Enrollment : 65 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Contrast Enhanced Ultrasound Scanning of Kidney and Pancreas Transplantation (Proof of Principle Study)
Study Start Date : October 2013
Estimated Primary Completion Date : September 2014
Estimated Study Completion Date : September 2014

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Kidney transplant recipients
CEUS in Kidney Transplant recipients
Other: Contrast Enhanced Ultrasound Scanning
Other Name: CEUS

Pancreas transplant recipients
CEUS in pancreas transplant recipients
Other: Contrast Enhanced Ultrasound Scanning
Other Name: CEUS




Primary Outcome Measures :
  1. To ensure feasibility of conducting CEUS post renal and pancreas transplantation [ Time Frame: Likely 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.

  2. To assess patient acceptability of performing CEUS in the peri-operative period [ Time Frame: Likely to be within 24 hours post surgery ]
    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.


Secondary Outcome Measures :
  1. Compare the quantification (likely expressed as percentage) of organ perfusion from CEUS, with our current gold standard, the nuclear renogram. [ Time Frame: 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.

  2. Post-operative complications [ Time Frame: Up-to patient discharge, likely 2 weeks ]
    A note of all post-operative complications, up-to discharge will be assessed.


Other Outcome Measures:
  1. Assess blood flow and morphology of the implanted pancreas [ Time Frame: Likely to be within 24 hours post surgery ]
    Descriptive analysis of vasculature and morphology of the implanted pancreata, high-lighting potential cause of concerns eg. thrombus, bleeding, collections



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Kidney and pancreas transplant recipients
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02104024


Contacts
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Contact: Hussein A Khambalia, BMBS, MRCS, BMedSci 00 (44) 1612761234 hussein.khambalia@cmft.nhs.uk
Contact: David van Dellen, MBBS, FRCS, MD 00 (44) 1612761234 david.vandellen@cmft.nhs.uk

Locations
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United Kingdom
Manchester Royal Infirmary Recruiting
Manchester, United Kingdom, M13 9WL
Contact: Khambalia       hussein.khambalia@cmft.nhs.uk   
Principal Investigator: Hussein A Khambalia, BMBS, BMedSci, MRCS         
Principal Investigator: David van Dellen, MBBS, FRCS, MD         
Sponsors and Collaborators
University of Manchester
Manchester University NHS Foundation Trust
Investigators
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Principal Investigator: Hussein A Khambalia, BMedSci, BMBS, MRCS Manchester Royal Infirmary

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Responsible Party: Hussein Khambalia, Clinical research Fellow, University of Manchester
ClinicalTrials.gov Identifier: NCT02104024    
Other Study ID Numbers: HAK 1.0
First Posted: April 4, 2014    Key Record Dates
Last Update Posted: April 4, 2014
Last Verified: April 2014
Keywords provided by Hussein Khambalia, University of Manchester:
Kidney
Pancreas
Transplant
Contrast Enhanced Ultrasound
Additional relevant MeSH terms:
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Pancrelipase
Pancreatin
Gastrointestinal Agents