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The A2ALL study was conducted by the study investigators and supported by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The resources from the A2ALL (https://doi.org/10.58020/wyz7-0r97) study reported here were supplied by NIDDK Central Repository (NIDDK-CR) and are available for request at https://repository.niddk.nih.gov. This manuscript was not prepared under the auspices of the A2ALL study and does not necessarily reflect the opinions or views of the A2ALL study, NIDDK-CR, or NIDDK.
Data Package Version
Version 3 (Updated on: Feb 07, 2019)
Resource Availability
- Data Available for Request
- Specimens Available for Request
- Images Available for Request
General Description
The Adult-to-Adult Living Donor Liver Transplantation Cohort Study (A2ALL) was a consortium of 9 U.S. liver transplant centers performing adult-to-adult living donor liver transplant (AALDLT) with the primary goal of examining outcomes of AALDLT versus deceased donor liver transplant (DDLT). AALDLT is a relatively new procedure increasingly used at major transplantation centers. Relatively small numbers of cases are performed at any one center and approaches to the patient and donor are too diverse across centers to provide reliable and generalizable information on donor and recipient outcomes from individual centers. Therefore, the consortium was organized to accrue and follow sufficient numbers of patients being considered for and undergoing AALDLT to provide generalizable results from adequately powered studies.
The Adult to Adult Living Donor Liver Transplantation Cohort Study (A2ALL) consisted of both retrospective and prospective studies of AALDLT. Legacy data from the A2ALL retrospective cohort is housed in the NIDDK Data Repository. The A2ALL retrospective cohort comprised 819 adult patients, each with a potential living donor, evaluated between January 1, 1998 and February 28, 2003. The retrospective study was designed to gain initial insights into outcomes associated with liver transplant procedures, with data drawn from existing medical records and patient materials. It was hypothesized that pursuit of a living liver allograft leads to decreased pre-transplant morbidity and mortality and better long term outcomes for patients starting from the point at which listed patients have a potential donor evaluated (at least a history and physical examination). The study analyzed numerous variables to determine the factors influencing allograft survival in recipients.
The A2ALL study showed evidence that AALDLT is a viable option for liver replacement with outcomes that improve with center experience. Donor characteristics associated with survival included younger age and cold ischemia time of the right lobe graft.
MRI and CT Scan images from subjects enrolled in A2ALL are not included in the data package, but are available upon request.
Objectives
The primary study objective of the A2ALL Retrospective Cohort Study is to determine whether the decision to undergo adult-to-adult living donor liver transplant is beneficial for the patients who choose this type of transplant. The principal hypothesis was that receipt of a living liver allograft leads to better long term outcomes for liver transplant candidates than pursuit of cadaveric transplant. Secondary objectives included addressing selected biological and clinical issues in transplantation structured around the comparison between DDLT and AALDLT.
Outcome Measure
A comparison of the mortality of AALDLT patients to the mortality of patients who have not yet received AALDLT was used as the primary outcome measure. The survival and rejection episodes for AALDLT vs. cadaveric recipients from time of transplant were also compared.
Eligibility Criteria
The eligibility criteria for recipients included:
- Potential recipient listed for single organ (liver) transplantation
- Eligible for AALDLT
- At least 18 years of age at the time of donor history and physical exam
- Indication for transplant of non-fulminant liver disease
- Potential donor identified and scheduled for evaluation (history and physical examination) within four weeks
The eligibility criteria for donors included:
- Met donor criteria of the transplant center
- At least 18 years of age at the time of donation
- Evaluated with a history and physical examination at the transplantation center
Outcome
The A2ALL study showed evidence that AALDLT is a viable option for liver replacement. The donor characteristics associated with acceptance were younger age and cold ischemia time of the right lobe graft. Additionally, data demonstrated that AALDLT is a procedure in which center experience plays a significant role in outcome, with outcomes that improve with experience.
Research Area
Liver Disease
Study Type
Observational
Study Sites
9
Study Start Date
2003-02
Study End Date
2014-08
Condition
Cirrhosis of Liver, Cancer, Hepatocellular Carcinoma
Image Data
Magnetic Resonance Imaging (MRI), Computed Tomography (CT) Scan
Clinical Trials URL
Keywords
Deceased Donor Liver Transplant, Liver Disease, Liver Replacement, Allograft, Liver Transplant
NIDDK Division
Division of Digestive Diseases and Nutrition
1,603
Participants
Target Population
Transplant Patients, Adults
If you need accessible versions of documents, please email your request to NIDDK-CRsupport@niddk.nih.gov
Permitted Use(s) of the Resources
- Use is allowed only for the specified disease(s), disorder(s), condition(s), or research area(s): Liver Disorder; Living Donation
Non-Public Documents (10)
Document Name | Description | Document Type | File Format |
|---|---|---|---|
IDs with Images | Contains each patient ID, study date, modality (CT, MRI, MR) and study instance UID | Data Description | XLSX |
Donor Data Crosswalk | Crosswalk for donor subjects that includes the data collection form, the label, the variable name, and the format where applicable | Data Description | XLS |
Recipient Data Crosswalk | Crosswalk for recipient subjects that includes the data collection form, the label, the variable name, and the format where applicable | Data Description | XLS |
Datasets (61)
Dataset Name | Description | # of Records | # of Variables | File Format(s) |
|---|---|---|---|---|
Recipient HCV Transplant Information Core Dataset | Contains subject-level data from the HCV Transplant Information case report form | 506 | csv (80.52 KB); sas7bdat (384 KB) | |
Donor HRQOL-Only Donors Complications Core Dataset | Complication-level dataset for HRQOL-only donors from the 3 new A2ALL centers. It includes the data elements on the Core HRQOL Only Donor Complications form. Patients in this dataset have as many records as their number of complications during the first year post-donation | 174 | csv (12.86 KB); sas7bdat (128 KB) | |
Cumulative Incidence for Specific Cause of Death 7 Dataset | Datasets used to calculate the p-values in Figure 2 of the publication by Olthoff et al. (2015) using the macro %compcift | 1430 | csv (43.23 KB); sas7bdat (128 KB) | |
Recipient Evaluation Core (Retrospective) Dataset | Captures recipient evaluation data | 1664 | csv (625.79 KB); sas7bdat (3.27 MB) | |
Donor Complications Core (All Phases) Dataset | Contains data from the Retro Donor Morbidity and Complication Severity Forms, Cohort Donor Morbidity & Complication Severity Form, and Core Donor Complications Form. Patients in this dataset have as many records as their number of complications during the follow-up period | 834 | csv (103.63 KB); sas7bdat (768 KB) | |
Cumulative Incidence for Specific Cause of Death 5 Dataset | Datasets used to calculate the p-values in Figure 2 of the publication by Olthoff et al. (2015) using the macro %compcift | 1430 | csv (43.23 KB); sas7bdat (128 KB) | |
Recipient Pre-Transplant Core (Retrospective) Dataset | Captures pre-transplant data on recipients | 1761 | csv (378.78 KB); sas7bdat (2.34 MB) | |
Recipient Post-Transplant Core (Retrospective) Dataset | Captures post-transplant data on recipients | 9131 | csv (2.39 MB); sas7bdat (19.03 MB) | |
Cumulative Incidence for Specific Cause of Death 3 Dataset | Datasets used to calculate the p-values in Figure 2 of the publication by Olthoff et al. (2015) using the macro %compcift | 1430 | csv (43.24 KB); sas7bdat (128 KB) | |
Recipient Donor Evaluation and Enrollment Core (All Phases) Dataset | Contains patient-level data at donor evaluation and links all the data elements on the following Retro forms: - Study Enrollment - Recipient Demographics - Recipient Condition at Enrollment - HCC Data at Enrollment - HCV Data at Enrollment with the data elements on the following Cohort forms: - PHI Form - Recipient Study Entry Information - Recipient Condition at Time of Donor Evaluation - HCC Data at Enrollment - HCV Data at Enrollment And the information from the recipient study entry information CRF from Core | 2069 | csv (804.45 KB); sas7bdat (4.7 MB) | |
Long-Term Quality of Life Survey Core Dataset | Contains data from the long-term HRQOL surveys. Donors in this dataset have up to 3 records depending on how many times they were surveyed | 1421 | csv (1.02 MB); sas7bdat (58.57 MB) | |
Recipient Basic Core (All Phases) Dataset | Contains patient-level information such as demographics, diagnoses, transplant, graft status, vital status, and follow-up for recipients who were enrolled in any or all phases of A2ALL. In most cases, it is necessary to merge this file with other recipient SAFs to perform analytical tasks | 2318 | csv (1.39 MB); sas7bdat (5.86 MB) | |
Prospective HRQOL Survey Core Dataset | Survey-level dataset containing responses to all survey questions from the prospective HRQOL survey. Donors have up to 5 records depending on how many times they were surveyed | 1102 | csv (886.01 KB); sas7bdat (16.92 MB) | |
Recipient Post-Transplant Core (All Phases) Dataset | Post-transplant form-level dataset that links all the data elements on the following Retro forms: - Graft Outcomes - Recipient Survival - HCC Recurrence & Rx and the non-biopsy-related variables on the Retro HCV Recurrence & Rx form with the data elements on the following Cohort forms: - Recipient Condition at Post-transplant (at week 1, week 2, month 1, month 3, month 6, and year 1 – year 11) - HCC Post-transplant Assessment (at month 6, month 12, month 18, and year 2 – year 10) - HCV Post-transplant Assessment (at week 1, month 1, month 3, and year 1- year 10) and the following Core forms: - Recipient post-transplant assessment (week 1, week 2, month 1, month 3, annual) Patients in this dataset have multiple records, each for one post-transplant time point. | 11994 | csv (3.43 MB); sas7bdat (32.66 MB) | |
Recipient Listing Core Dataset | Captures patient-level information at listing; data is collected from the following Retro listing forms: List and Transplant Information, Recipient Condition at Listing, and HCC Data at Listing | 818 | csv (149.08 KB); sas7bdat (320 KB) | |
Cumulative Incidence for Specific Cause of Death 1 Dataset | Datasets used to calculate the p-values in Figure 2 of the publication by Olthoff et al. (2015) using the macro %compcift | 1430 | csv (43.24 KB); sas7bdat (128 KB) | |
Outcomes Core (All Phases) Dataset | Full set including LDLT case 1-20 (this is only used to get the number of inexperienced cases excluded) | 1603 | csv (2.07 MB); sas7bdat (6.75 MB) | |
Donor Hospitalization Core (Retrospective) Dataset | Hospitalization-level dataset that includes the data elements on the Retro, Cohort and Core Donor Hospitalization forms. Patients in this dataset have as many records as their number of hospital admissions during the follow-up period | 990 | csv (61.92 KB); sas7bdat (192 KB) | |
Recipient HCV Advanced Disease Assessment Core Dataset | Contains information collected on the HCV Advanced Disease Assessment case report form; data includes clinical symptoms related to HCV recurrence | 505 | csv (66.31 KB); sas7bdat (448 KB) | |
Recipient Explant Core (All Phases) Dataset | Dataset that merges all the data elements on the Retro, Cohort and Core HCC at Explant forms for patients with hepatocellular carcinoma | 415 | csv (47.42 KB); sas7bdat (256 KB) | |
Recipient Post-Transplant Biopsy Core (All Phases) Dataset | Biopsy-level dataset for patients post-transplant that includes the biopsy-related variables on the Retro HCV Recurrence & Rx form, all the data elements on the Cohort HCV Post-transplant Biopsy Pathology Report and all the data elements from the Core post-transplant biopsy results form. Patients in this dataset have multiple records, depending on how many biopsies they have undergone since transplant | 3084 | csv (464.92 KB); sas7bdat (2.25 MB) | |
Recipient Intraoperative Core (Retrospective) Dataset | Patient-level intraoperative dataset that links all the data elements on the Retro Recipient Intraoperative form, Cohort LDLT and DDLT Recipient Intraoperative forms, and Core Intraoperative form | 1279 | csv (291.84 KB); sas7bdat (2.99 MB) | |
Cumulative Incidence for Causes of Graft Failure 2 Dataset | Dataset used to calculate the p-values in Figure 3 of the publication by Olthoff et al. (2015), Unadjusted cumulative incidence for causes of graft failure (summarized as re-transplant or death without re-transplant) by transplant type, using the macro %compcift | 1430 | csv (43.34 KB); sas7bdat (128 KB) | |
Recipient Transplant Core (Retrospective) Dataset | Captures patient-level data at transplant; dataset links all the data elements on the following Retro forms: - Recipient Condition at Transplant - HCC Data at Transplant - HCV Data at Transplant with the data elements on the following Cohort forms: - Recipient Condition at Transplant - HCC Data at Transplant - HCV Data at Transplant and selected data elements from the following Core forms: - Recipient intraoperative - Recipient study entry information | 1261 | csv (428.92 KB); sas7bdat (1.99 MB) | |
Cumulative Incidence for Specific Cause of Death 8 Dataset | Datasets used to calculate the p-values in Figure 2 of the publication by Olthoff et al. (2015) using the macro %compcift | 1430 | csv (43.24 KB); sas7bdat (128 KB) | |
Donor Hospitalization Core (All Phases) Dataset | Hospitalization-level dataset that includes the data elements on the Retro, Cohort and Core Donor Hospitalization forms. Patients in this dataset have as many records as their number of hospital admissions during the follow-up period | 1918 | csv (459.5 KB); sas7bdat (704 KB) | |
Donor Evaluation Core (Retrospective) Dataset | a patient-level dataset at the time of evaluation. It links all the data elements on the following Retro forms: - Donor Demographics - Donor Evaluation with the data elements on the following Cohort forms: - Donor Study Entry Information - Donor Evaluation This information was not collected in Core. | 1881 | csv (560.74 KB); sas7bdat (2.34 MB) | |
Morbidity and Complication Core (All Phases) Dataset | Contains complication-level data from the Retro Recipient Morbidity and Complication Severity, Cohort Recipient Morbidity & Complication Severity, and the Core Recipient Complications forms. Patients in this dataset have as many records as the number of complications experienced during the follow-up period | 6593 | csv (838.46 KB); sas7bdat (6.89 MB) | |
Donor Post-Donation Core (All Phases) Dataset | Post-donation form-level dataset that links all the data elements on the Retro Donor Survival form, Cohort Donor Assessment Post-donation and Core post-donation forms. Patients in this dataset have multiple records, one for each post-donation time point | 6289 | csv (1.02 MB); sas7bdat (6.56 MB) | |
Donor HRQOL-Only Donors Core Dataset | Patient-level dataset for HRQOL-only donors from the 3 new A2ALL centers. It includes data elements from the Core HRQOL Only Donor Assessment form | 396 | csv (43.55 KB); sas7bdat (192 KB) | |
Recipient Transplant Core (All Phases) Dataset | Captures patient-level data at transplant; dataset links all the data elements on the following Retro forms: - Recipient Condition at Transplant - HCC Data at Transplant - HCV Data at Transplant with the data elements on the following Cohort forms: - Recipient Condition at Transplant - HCC Data at Transplant - HCV Data at Transplant and selected data elements from the following Core forms: - Recipient intraoperative - Recipient study entry information | 1902 | csv (766.38 KB); sas7bdat (3.52 MB) | |
Cumulative Incidence for Specific Cause of Death 6 Dataset | Datasets used to calculate the p-values in Figure 2 of the publication by Olthoff et al. (2015) using the macro %compcift | 1430 | csv (43.24 KB); sas7bdat (128 KB) | |
Recipient Intraoperative Core (All Phases) Dataset | Patient-level intraoperative dataset that links all the data elements on the Retro Recipient Intraoperative form, Cohort LDLT and DDLT Recipient Intraoperative forms, and Core Intraoperative form | 1924 | csv (766.63 KB); sas7bdat (7.75 MB) | |
Recipient HCV Transient Elastography Report Core Dataset | Contains information collected on the HCV Transient Elastography Report case report form; procedure-level data includes the results from one elastography scan | 64 | csv (2.47 KB); sas7bdat (128 KB) | |
Cumulative Incidence for Specific Cause of Death Risk Dataset | Dataset used to calculate the cumulative incidence of causes of death for Figure 2 in the publication by Olthoff et al. (2015) using the macro %compriskt | 1430 | csv (43.24 KB); sas7bdat (128 KB) | |
Recipient Hospitalization Core (All Phases) Dataset | Contains hospitalization-level data elements collected on the Retro, Cohort and Core Recipient Hospitalization forms. Patients in this dataset have as many records as the number of hospital admissions during the follow-up period | 7856 | csv (580.53 KB); sas7bdat (3.31 MB) | |
Cumulative Incidence for Causes of Graft Failure Risk Dataset | This dataset is used to calculate the cumulative incidence of causes of graft failure (retransplant or death) for Figure 3 in the publication by Olthoff et al. (2015) using the macro %compriskt | 1430 | csv (43.34 KB); sas7bdat (128 KB) | |
Recipient Basic Core (Retrospective) Dataset | Contains patient-level information such as demographics, diagnoses, transplant, graft status, vital status, and follow-up for recipients. In most cases, it is necessary to merge this file with other recipient SAFs to perform analytical tasks | 1664 | csv (877.67 KB); sas7bdat (2.15 MB) | |
Cumulative Incidence for Specific Cause of Death 4 Dataset | Datasets used to calculate the p-values in Figure 2 of the publication by Olthoff et al. (2015) using the macro %compcift | 1430 | csv (43.24 KB); sas7bdat (128 KB) | |
Recipient Rejection Core (Cohort) Dataset | Rejection-level dataset that contains the data elements from the Retro Recipient Baseline Immunosuppression and Recurrent Rejection Episodes form and the Cohort Rejection Episodes and Treatment form. Patients in this dataset have as many records as the number of rejections they had experienced during the follow-up period | 676 | csv (81.36 KB); sas7bdat (512 KB) | |
Cumulative Incidence for Specific Cause of Death 2 Dataset | Datasets used to calculate the p-values in Figure 2 of the publication by Olthoff et al. (2015) using the macro %compcift | 1430 | csv (43.24 KB); sas7bdat (128 KB) | |
Donor Basic Core (Retrospective) Dataset | Contains patient-level data on demographics, relationship to recipient, donation, vital status, and follow-up for donors | 1881 | csv (531.09 KB); sas7bdat (960 KB) | |
Recipient Listing Core (Retrospective) Dataset | Captures patient-level information at listing; data is collected from the following Retro listing forms: List and Transplant Information, Recipient Condition at Listing, and HCC Data at Listing | 818 | csv (149.08 KB); sas7bdat (320 KB) | |
Recipient HCV Study Subject Flow Core Dataset | Contains information from the HCV Study Subject Flow case report form, which was used as a screening tool to determine if a subject was eligible for the Core HCV sub-study and if so, which other HCV CRFs should be completed | 483 | csv (28.49 KB); sas7bdat (192 KB) | |
Recipient HCV Study Information Core Dataset | Captures subject-level data from the HCV Study Information case report form | 461 | csv (90.99 KB); sas7bdat (448 KB) | |
Donor Intraoperative Core (Retrospective) Dataset | Patient-level intraoperative dataset that links all the data elements on the Retro, Cohort and Core Intraoperative Data forms | 775 | csv (194.21 KB); sas7bdat (1.25 MB) | |
Donor Intraoperative Core (All Phases) Dataset | Patient-level intraoperative dataset that links all the data elements on the Retro, Cohort and Core Intraoperative Data forms | 1610 | csv (434.81 KB); sas7bdat (5.41 MB) | |
Outcomes Analysis Dataset | This is the dataset that is analyzed in the manuscript; data includes enrollment information, graft outcomes, diagnoses, etc. | 1430 | csv (1.83 MB); sas7bdat (6 MB) | |
Donor Post-Donation Core (Retrospective) Dataset | Post-donation form-level dataset that links all the data elements on the Retro Donor Survival form, Cohort Donor Assessment Post-donation and Core post-donation forms. Patients in this dataset have multiple records, one for each post-donation time point | 4201 | csv (623.49 KB); sas7bdat (4.22 MB) | |
Donor Complications Core (Retrospective) Dataset | Contains data from the Retro Donor Morbidity and Complication Severity Forms, Cohort Donor Morbidity & Complication Severity Form, and Core Donor Complications Form. Patients in this dataset have as many records as their number of complications during the follow-up period | 634 | csv (81.33 KB); sas7bdat (576 KB) | |
Recipient Hospitalization Core (Retrospective) Dataset | Contains hospitalization-level data elements collected on the Retro, Cohort and Core Recipient Hospitalization forms. Patients in this dataset have as many records as the number of hospital admissions during the follow-up period | 6203 | csv (451.83 KB); sas7bdat (832 KB) | |
Recipient Explant Core (Retrospective) Dataset | Dataset that merges all the data elements on the Retro, Cohort and Core HCC at Explant forms for patients with hepatocellular carcinoma | 281 | csv (29.79 KB); sas7bdat (192 KB) | |
Morbidity and Complication Core (Retrospective) Dataset | Contains complication-level data from the Retro Recipient Morbidity and Complication Severity, Cohort Recipient Morbidity & Complication Severity, and the Core Recipient Complications forms. Patients in this dataset have as many records as the number of complications experienced during the follow-up period | 4619 | csv (617.46 KB); sas7bdat (4.84 MB) | |
Donor Pain Survey Core Dataset | Captures data from donor responses to the APSPOQ-R. Of the 178 donors in the dataset 6 were not surveyed and reasons are noted in the variable S1_survey_not_completed_reason | 178 | csv (31.01 KB); sas7bdat (256 KB) | |
Cumulative Incidence for Causes of Graft Failure 1 Dataset | Dataset used to calculate the p-values in Figure 3 of the publication by Olthoff et al. (2015), Unadjusted cumulative incidence for causes of graft failure (summarized as re-transplant or death without re-transplant) by transplant type, using the macro %compcift | 1430 | csv (43.34 KB); sas7bdat (128 KB) | |
Recipient Post-Transplant Biopsy Core (Retrospective) Dataset | Biopsy-level dataset for patients post-transplant that includes the biopsy-related variables on the Retro HCV Recurrence & Rx form, all the data elements on the Cohort HCV Post-transplant Biopsy Pathology Report and all the data elements from the Core post-transplant biopsy results form. Patients in this dataset have multiple records, depending on how many biopsies they have undergone since transplant | 1005 | csv (115.23 KB); sas7bdat (512 KB) | |
Donor Basic Core (All Phases) Dataset | Contains patient-level data on demographics, relationship to recipient, donation, vital status, and follow-up for donors who were enrolled in any phase of A2ALL as well as all A2ALL substudies | 2742 | csv (919.92 KB); sas7bdat (3.45 MB) | |
Specimens (65,786)
Specimen | Count |
|---|---|
| Cells | 739 |
| EBV Transformed Cell Lines | 5831 |
| Liver Tissue | 3201 |
| Lymphocytes | 1763 |
| Serum | 54252 |