Kidney TransplantationNCT02104024
CEUS in Kidney and Pancreas Transplantation
An observational study of Kidney Transplantation and Pancreas Transplantation, run by University of Manchester at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplantation, Pancreas Transplantation
- What is being tested?
- Contrast Enhanced Ultrasound Scanning
- How many people
- 65 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2013to Sep 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Kidney and pancreas transplant recipients
Who may be able to join
- adult kidney transplant recipients
- adult pancreas transplant recipients
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Manchester Royal Infirmary
Manchester, M13 9WL
Khambalia, hussein.khambalia@cmft.nhs.uk
Hussein A Khambalia, BMBS, BMedSci, MRCS
About this study
Official title: 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.
- Conditions
- Kidney Transplantation, Pancreas Transplantation
- Being tested
- Contrast Enhanced Ultrasound Scanning
- Keywords
- Kidney, Pancreas, Transplant, Contrast Enhanced Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrast Enhanced Ultrasound ScanningOther
Also called CEUS
| Study group | Role | What they receive |
|---|---|---|
| Kidney transplant recipients | CEUS in Kidney Transplant recipients Receives: Other: Contrast Enhanced Ultrasound Scanning | |
| Pancreas transplant recipients | CEUS in pancreas transplant recipients Receives: Other: Contrast Enhanced Ultrasound Scanning |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
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.
Measured: 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.
Measured: Up-to patient discharge, likely 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2014 (estimated)
- Study startOct 2013
- Primary completionSep 2014 (estimated)
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Collaborators
- Manchester University NHS Foundation Trust
- Responsible party
- Principal investigator, Hussein Khambalia, University of Manchester
- Investigators
- Hussein A Khambalia, BMedSci, BMBS, MRCS, Principal investigator, Manchester Royal Infirmary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02104024
- Sponsor's protocol ID
- HAK 1.0
- Status last verified
- Apr 2014
- First submitted
- 12 Feb 2014
- Last updated
- 4 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contrast Enhanced Ultrasound Scanning of Kidney and Pancreas Transplantation (Proof of Principle Study)
- ClinicalTrials.gov ID
- NCT02104024
- Acronym / sponsor ID
- HAK 1.0
- Conditions
- Kidney Transplantation, Pancreas Transplantation
- Keywords
- Kidney, Pancreas, Transplant, Contrast Enhanced Ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Collaborators
- Manchester University NHS Foundation Trust
- Study start
- Oct 2013
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 4 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kidney transplant recipients | – | Other: Contrast Enhanced Ultrasound ScanningCEUS in Kidney Transplant recipients |
| Pancreas transplant recipients | – | Other: Contrast Enhanced Ultrasound ScanningCEUS in pancreas transplant recipients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Kidney and pancreas transplant recipients
Key inclusion criteria (2 listed)
- adult kidney transplant recipients
- adult pancreas transplant recipients
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contrast Enhanced Ultrasound ScanningAlso: CEUS | Other | Kidney transplant recipients, Pancreas transplant recipients |
Primary outcome
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.
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.
2 secondary outcomes
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.
Post-operative complications
Time frame: Up-to patient discharge, likely 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hussein A Khambalia, BMedSci, BMBS, MRCS principal investigator
Manchester Royal Infirmary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplantation and Pancreas Transplantation, run by University of Manchester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hussein A Khambalia, BMBS, MRCS, BMedSci (00 (44) 1612761234, hussein.khambalia@cmft.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To ensure feasibility of conducting CEUS post renal and pancreas transplantation (time frame: Likely to be 24 hours post surgery.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2014.