Clinical trial NCT01619475: Adult-to-Adult Living Donor Transplant Cohort Study
Official title: A2ALL: Adult-to-Adult Living Transplant Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Diseases
Hepatocellular Cancer
End Stage Liver Disease
Hepatitis C
Liver Cirrhosis
Keywords: Living Donor
Liver Transplantation
Quality of Life
Biosamples
Liver Recipient
Lead sponsor: Arbor Research Collaborative for Health
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2012-06-14
Enrollment: 1871
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The sample population will consist of the following:

* Donors and LDLT and DDLT recipients enrolled in the original A2ALL cohort study.
* Donors and LDLT recipients where the donation/transplant occurred during the period of time that began with the end of enrollment into the original Cohort study (August 31, 2009) and ended with the opening of enrollment in the current core protocol; this is referred to as the "Gap Era."
* Prospective donors and LDLT recipients for donation/transplant surgery.
* HCV-infected adult liver transplant recipients enrolled in the A2ALL-1 Cohort and from those currently transplanted at the new A2ALL-2 centers (University of Toronto, University of Pittsburgh, and Lahey Clinic).

Brief summary: The study is being conducted for the following reasons:

1. To determine the prevalence, course, and predictors of poor Health Related Quality of Life (HRQOL) outcomes associated with living donor donation.
2. To collect data and biosamples prior to, during, and after a living donor liver transplant (LDLT) among all donors and recipients for use by other adult-to-adult living donor liver transplant studies and future studies.
3. To study the effects of pressure and flow on the outcomes of LDLT.
4. To characterize the differences between living donor liver transplant and deceased donor liver transplant in terms of recipient post-transplant outcomes including patient and graft survival, surgical morbidity, and resource utilization.
5. To compare the long-term histological outcomes in recipients of LDLT and deceased donor liver transplant (DDLT) with recurrent hepatitis C virus (HCV) infection.
6. To understand the history of pain management and to measure quality of care in pain control in living donors following partial hepatectomy.

Detailed description: The procedure of adult-to-adult living donor liver transplant (LDLT) is an extraordinary surgical therapy that involves the removal of 70% of the volume mass of an adult donor liver and its implantation into an adult recipient. A critical shortage of deceased donor livers, resulting in premature mortality among candidates in need of liver transplantation, remained the single most compelling force driving the need for adult-to-adult LDLT. Patients awaiting living donor liver transplant will be asked to enroll in this protocol at the time of identification of a potential living liver donor. Donors identified for the living donation will also be asked to enroll in the protocol. Donors and recipients who have already participated in a liver donation/transplant will be approached to join the protocol based on their clinical history.

Optimizing donors' health-related quality of life is a foremost goal for liver donor liver transplant programs and an overarching aim for this study. The proposed A2ALL-2 Health Related Quality of Life (HRQOL) Sub-Study will build upon the A2ALL HRQOL measures employed to date. There is a critical need to look at the important difficulties that liver donors appear to face not only in the early years but in the long-term after donation. Individuals who have enrolled in the study and are going to donate a portion of their liver will complete a HRQOL battery of tests conducted over the phone by experienced staff at Northwestern University or the University of Pittsburgh. The tests are a series of questions given to the upcoming donor at baseline (prior to the liver donation), at Month 3, and Month 6, Year 1 and Year 2 following donation. The new donor will complete up to 5 interviews by the survey research team. Individuals who have already donated (long-term donors), and out three years since donation can be enrolled, but they have to have donated in 2002 or more recently. Long-term follow-up donors will complete up to 4 interviews by the survey research team.

As LDLT moved from children to adults, it was observed early that the size of the graft was related to function in the recipient and that inadequate graft volume led to poor recipient outcomes. It has been found, that when the graft of the liver is too small, then the recipient can develop a number of symptoms including persistent ascites (fluid in the abdomen) and the graft becomes resistant to the passage of blood. This study hopes to develop and validate approaches that permit successful use of smaller donor livers and this is the principal goal of the surgical innovations portion of the study. The study will use standard surgical technique for the donor and recipient. Either right or left lobe donation and transplantation will be performed based on clinical parameters for graft selection.

Biosample collection of serum aliquots and liver tissue samples will be collected from subjects during different timepoints in the study. The collection of patient biosamples and DNA samples provides a resource with which researchers can rapidly validate clinical hypotheses and algorithms for clinical decision making. The collections also advance the development of diagnostic and prognostic markers and therapeutics. In addition, collection and storage of DNA samples may increase the sample size and the resulting power of a study to identify genetic determinants of a disease. The samples will be stored in the National Institute of Diabetic, Digestive and Kidney diseases (NIDDK) Repositories.

Hepatic C virus (HCV) recurrence after liver transplantation is universal in patients who have the virus pre-operatively. Chronic hepatitis evolves to a cirrhosis at a variable rate, but more rapidly than in non-transplant patients. The study will evaluate whether risk factors for aggressive HCV recurrence after DDLT also apply to LDLT recipients in long-term follow-up.

Pain control in living donors following partial hepatectomy will be measured as quality of care. The transplant community has no objective information about pain management in live liver donors to use for quality improvement. A validated tool to measure quality of pain management will be used to assess multidimensional aspects of pain care.

The following details the schedule of visits and the tests/procedures to be performed at each visit:

Recipient (before the surgery)

* Provide blood samples for the NIDDK Biosample Repository.
* Undergo imaging studies either Computed Assisted Tomography (CAT) or a Magnetic Resonance Imaging (MRI) to measure the size of the liver and spleen.
* If one has liver cancer or hepatocellular carcinoma (HCC), information will be collected about the tumor(s) and treatment.

Recipient (day of surgery)

* Provide a sample of the new liver to the NIDDK Biosample Repository.
* Provide blood samples immediately before and during the transplant surgery to the NIDDK Biosample Repository.
* Allow the researchers to collect information about the transplant surgery.
* Allow the researchers to collect information about any complications that develop after the transplant.
* During the transplant operation, an ultrasound probe will be applied to the two vessels going to the transplanted liver and a measurement of how much blood flows through these vessels to the liver will be taken. After less than 5 minutes the probe will be removed. Additionally, measurements will be taken of the pressure in one of the vessels, the portal vein, with a very small needle inserted by the surgeon. These measurements will be recorded and analyzed as part of the study.
* During living donor transplant surgery, it is occasionally necessary to adjust the blood flow to the liver to improve the function. If the surgeon determines that the flow to the liver needs to be adjusted, the measurements described above will be repeated after the adjustments have been made. These measurements will be recorded and analyzed as part of the study.
* Additional tests which are standard of care may also be carried out at the site.
* If one has HCC,then information will be collected about the tumor(s).

Recipient(immediately after the surgery)

* Provide blood samples during the first and second weeks after the transplant to the NIDDK Biosample Repository.
* Allow the researchers to collect information about the lab tests (liver function tests, blood counts,etc.).
* Undergo an ultrasound measurement of the blood flow through the portal vein on the day after the operation.
* Additional tests which are standard of care may be also carried out at the site.

Recipient (throughout the course of the study)

* Provide blood samples to the NIDDK Biosample Repository at months 1, 3, and 12, and annually thereafter though August 2014. Approximately 10 teaspoons or 50 ccs of blood will be collected at each assessment.
* Undergo imaging studies at three months after the operation (either a CAT or MRI) of the liver and spleen to see how much the liver has grown since the transplant operation.
* Return to the transplant center for assessment at months 1,3, and 12, and annually thereafter through August 2014.
* Allow the researchers to collect information about any hospitalizations that occur after the transplant operation.
* Allow the researchers to collect information about any complications that develop after the transplant, through August 2014.
* Allow the researchers to collect information about any liver biopsies that are performed after the transplant.
* If the subject has Hepatitis C (HCV) and is post-transplant, and has had a liver transplant from a living donor or a deceased donor, the subject will be asked permission for review of the chart and collect information about the pre-transplant HCV treatment, the transplant operation, the immunosuppression medications, rejection episodes, and any HCV treatment received prior to consenting to this study.
* If the subject has HCV,and has given permission, the chart will be reviewed for liver biopsy results that occurred at least three years after the transplant.
* If a liver biopsy was not done at least three years after the transplant or if the recent liver biopsy was at least three years after the transplant but the most recent liver biopsy was more than one year the subject will be a asked to come to the center and get a liver biopsy done.
* If the study liver biopsy is done, or information on a previous biopsy has been collected the slides of the liver tissue obtained will be sent to the central pathologist to read. The name of the subject and any other identifying information will not be on the slides. It will have a code number on it that links back to the subject's clinical data.
* If the HCV subject is unwilling or unable to undergo a liver biopsy, then the subject will be asked to undergo a procedure called "transient elastography". Transient elastography is a non-invasive procedure during which a sound wave is transmitted to the liver through an ultrasound probe, and the time it takes for the sound wave to travel through the liver is measured. Transient elastography is considered to be an experimental procedure. However, it has been well-studied, and there have been no adverse events or injuries with its use.
* If the subject has HCV, some blood will be collected for storage in the NIDDK Repository. Approximately 10 teaspoons or 50ccs of blood will be collected at that time.

Donor (before the surgery)

* The subject will be called on the telephone by the survey researchers to answer questions about health, and well-being as well as views about the donation process.
* The survey questions may take up to 45 minutes to complete.
* Provide blood cell samples for the NIDDK Biosample Repository. Approximately 12 teaspoons or 60 ccs of blood will be collected.
* Undergo an imaging study before the operation (either CAT or MRI) to measure the size of the liver and spleen.
* Additional tests which are standard of care may also be carried out at the site.

Donor (day of the surgery)

* Provide samples of liver to the NIDDK Biosample Repository.
* Allow the researchers to collect information about the donation surgery.
* Allow the researchers to collect information about any complications that develop after the donation.

Donor (immediately after the surgery)

* Two days after the surgery, the subject will be asked questions about their post-operative pain.
* Provide blood samples one week after the donation surgery to the NIDDK Biosample Repository. Approximately 5-6 teaspoons or 25-30ccs of blood will be collected.

Donor (throughout the course of the study)

* Provide blood samples to the NIDDK Biosample Repository at week 1, month 1, month 3, and month 12. Approximately 10 teaspoons or 50 ccs of blood will be collected at each assessment.
* Return to the transplant center for assessment at month 3, and annually thereafter through August 2014.
* Undergo an imaging study at three months after the operation (CAT or MRI) to measure the size of the liver and spleen to see how much the liver has grown back since the donation operation.
* If the subject entered this study prior to undergoing surgery, questions will have to be answered by telephone about quality of life after donation at 3, 6, 12, and 24 months following donation. These telephone interviews may take up to 45 minutes to complete.
* If the subject entered the study after living liver donation, questions will be asked over the telephone about quality of life upon study entry and then annually for three years. The telephone interviews may take 45 minutes to complete.
* Allow the researchers to collect information about any complications that develop after the donation operation, through August 2014.
* Allow the researchers to collect information about the hospitalizations that occur after the transplant operation.

Eligibility criteria: Inclusion Criteria:

Recipients

1. Age 18 or older at the time of consent
2. Has had a living donor identified and accepted and LDLT is planned
3. Informed consent obtained
4. Is listed for single organ (liver) transplantation

Donors

1. Age 18 or older at the time of consent
2. Has undergone donor evaluation process and was accepted and donation surgery is planned
3. Informed consent obtained

Exclusion Criteria:

None

Primary outcomes:
measure: Recipient patient and graft survival starting from the time of transplantation in LDLT & DDLT.
timeFrame: Yearly follow-up starting at transplant, measured between enrollment and up to 4 years.
measure: Number and severity of surgical complications and resource utilization after transplant.
timeFrame: Yearly follow-up starting at transplant, measured between enrollment , and up to 4 years.
measure: Health Related Quality of Life (HRQOL) in living liver donors.
timeFrame: Yearly assessment from donation up to 5 assessments.
measure: Number of Blood/Tissue Samples from Donors and Recipients.
timeFrame: Yearly samples starting at transplant/donation (donors until year 1, and recipients until year 4.)
measure: Pressure and Flow Measurements during the transplant surgery in LDLT recipients.
timeFrame: During the transplant (at completion of dissection, and after revascularization).
measure: Measures of liver fibrosis (Ishak score) in LDLT and DDLT recipients with recurrent HCV infection.
timeFrame: Enrollment up to 4 years, with data collected at the time of each liver biopsy.
measure: Pain control in living donors following partial hepatectomy
timeFrame: The first 48 hours after donation surgery
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California
state: California
city: Aurora
country: United States
facility: University of Colorado Health Sciences
state: Colorado
city: Chicago
country: United States
facility: Northwestern University, Division of Transplantation
state: Illinois
city: Burlington
country: United States
facility: Lahey Clinic
state: Massachusetts
city: New York
country: United States
facility: Columbia University
state: New York
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Richmond
country: United States
facility: Virginia Commonwealth University-Medical College of Virginia
state: Virginia
city: Toronto
country: Canada
facility: University of Toronto
state: Ontario
Study officials:
affiliation: University of Michigan
name: Robert M Merion, MD
role: STUDY_CHAIR
affiliation: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Averell Sherker, MD
role: STUDY_DIRECTOR
References:
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