Digestive System Diseases

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Liver Extracts

Individuals approved as liver donors and recipients shortly Pre-donation/Pre-transplant at the study sites.

Donors and recipients enrolled in the original A2ALL Cohort study.

Donors and LDLT recipients whose donation/transplant occurred during the period of time that began with the end of enrollment into the original Cohort study (Aug. 31, 2009) and ended with the opening of the enrollment in the current core protocol; this is referred to as the "Gap Era."

LDLT recipients and donors who were not in the original Cohort study or from the Gap Era will enter the study at time proximate to time of living donation.

Male and female HCV-infected adult liver transplant recipients from those enrolled in the A2ALL-1 Cohort study and from those concurrently transplanted at the new A2ALL-2 centers (University of Toronto, University of Pittsburgh, Lahey Clinic).

Robert M Merion, MD

Averell Sherker, MD

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.

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.

To collect biosamples prior to, during, and after LDLT among all donors and recipients. These biosamples include, liver biopsy,whole blood for genetic studies and DNA extraction, plasma, serum and peripheral cells to be retained in the bio-repository.

Adult-to-Adult Living Donor Transplant Cohort Study

A2ALL: Adult-to-Adult Living Transplant Cohort Study

To characterize the differences between LDLT and DDLT in terms of recipient post-transplant outcomes for patient and graft survival.

Comparison of incidence of defined medical and surgical complications after transplant between LDLT and DDLT.

Comparison of resource utilization (hospitalization) between LDLT and DDLT.

To estimate the prevalence, course, and predictors of poor HRQOL outcomes associated with living liver donation.

To collect data and biosamples prior to, during, and after LDLT among all donors and recipients for use by other A2ALL protocols and future studies.

To establish normal hepatic blood flow and portal compliance in the human liver, to examine the relationships among hepatic flow and pressure, graft size and function, and clinical outcomes.

To assess whether recurrent Hepatitis C is histologically less severe in LDLT compared with DDLT recipients.

Self-reported pain and satisfaction with pain management during the first 48 hours after donation surgery.

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Arbor Research Collaborative for Health

Volkan Ince, MD

Hepatocellular cancer is the 6th most common seen disease in the world and the 3rd in cancer-related deaths. Liver transplantation is the primary curative treatment of HCC, as it eliminates liver cancer and underlying cirrhosis. However, liver transplantation is not offered to every HCC patient, since advanced stage HCC patients are lost with tumor recurrence early after liver transplantation. The Milan criteria, which are accepted worldwide, are the patient selection criteria that we have to follow in cadaver-to-liver transplantation for HCC in our country. However, as the Milan criteria are very strict criteria, it pushes patients out of liver transplantation who exceed the Milan criteria but who can benefit from liver transplantation. Liver transplantation centers all over the world have declared their own criteria under the expanded Milan criteria. In our country, Malatya Criteria have been defined by İnönü University on this subject, and our studies on this subject still continue. When we scan the original articles of all these defined criteria, incomplete data are formed and therefore the strength of the criteria cannot be clearly revealed. For this reason, we aimed to analyze the results of our center and present information about the power of the criteria to the literature.

Aim: To investigate the criteria with the longest overall and disease-free survival and lowest recurrence rates in liver transplantation for hepatocellular cancer (HCC).

Introduction: When the liver transplant criteria for HCC were examined, we saw that many criteria defined in their original articles did not include the rates of extending the Milan criteria, survival and recurrence rates of non-milan patients who were within the newly defined criteria. Therefore, information on which of the criteria defined for liver transplantation in HCC extends the Milan criteria more, which has a longer survival rate and which has a lower recurrence rate is lacking. In order to eliminate this deficiency or at least to have a rough idea, we aimed to compare the results of liver transplantation, performed for HCC in our institute which is a high-volume liver transplant center, by analyzing it according to the existing defined criteria. Thus, we were able to compare the criteria in a homogeneous patient group that was formed as a result of the same inclusion and exclusion criteria in the same period of time. The highest overall and disease-free survival, the lowest recurrence rate, and the criterion that extends the Milan criteria will be introduced. In addition, this study is the first comprehensive comparison of liver transplant criteria for HCC.

Methods: Between March 2002 and July 2020, the data of 424 patients who underwent liver transplantation due to HCC at the Liver Transplantation Institute of İnönü University will be retrospectively analyzed from the prospectively recorded data bank and automation system. Tumor size, tumor number, differentiation and microscopic venous invasion data will all be recorded from the data in the explant pathology report. Since the primary aim of our study is cancer-related survival in patients who can be transplanted, 31 patients with tumor invasion outside the liver (extrahepatic portal vein tumor thrombosis, perihilar lymph node metastasis, diaphragmatic invasion etx) and 70 patients with follow-up period after liver transplantation below 90 days will be excluded from the study. The remaining 323 patients will be included in the study and their data will be analyzed. First, demographic data, tumor characteristics, overall and disease-free survival and recurrence rate of 323 HCC patients who were the study group, will be calculated, and then these patients will be divide groups according to be within or beyond the criteria, than survival and recurrence rates will be calculated. It was then examined whether these expanded criteria actually extended the Milan criteria. It was checked whether a defined Expanded criterion allowed liver transplantation for patients outside of Milan while excluding patients within Milan from liver transplantation. How far the expanded criteria expand the Milan and survival of the patients who beyond Milan but within the criteria were analyzed separately. Thus, the most useful criterion for liver transplantation in HCC treatment will be revealed.

Comparison of Criteria for Liver Transplantation in Hepatocellular Carcinoma

all IPD that underlie results in publication

Tumor free survival after liver transplantation

Overall survival after liver transplantation

Tumor recurrence following liver transplantation

Liver Transplant criteria which has the best survivals

Inonu University

Assoc.Prof.

Neoplasm Metastasis

Neoplastic Processes

Potential subjects for this registry must have Stage IV colorectal cancer with liver metastases and be candidates for liver transplantation based on multidisciplinary discussion by the Liver transplantation team. Patients must demonstrate favorable tumor biology and no evidence of extra hepatic disease.

Liver transplantation

Roberto Hernandez-Alejandro, MD

Jennie Errigo

Matthew Byrne, MD

The goal of this study is to create a data registry to capture clinical, pathologic, and molecular data/outcomes for patients with metastatic colorectal cancer who undergo live donor liver transplantation.

The goal of this study is to create a data registry to capture clinical, pathologic, and molecular data/outcomes for patients with metastatic colorectal cancer who undergo live donor liver transplantation.

Our primary outcome of interest was the OS and recurrence-free survival (RFS) of patients who underwent LDLT at our center.

After explant of the native liver, patients will be enrolled in a biorepository with planned collection of snap frozen tissue and plasma and formalin fixed and paraffin embedded samples.

Living Donor Liver Transplant for Unresectable Colorectal Liver Metastases

Liver Transplantation From Living Donors For Treatment Of Non-Resectable Colorectal Carcinoma Liver Metastases: A Registry Study

RFS proportions to be calculated at 1, 3, and 5 years with Kaplan Meier analysis

OS proportions to be calculated at 1, 3, and 5 years with Kaplan Meier analysis

University of Rochester

Professor

Liver transplant patients with MTD\>6 cm of HCC

Retrospective data on 50 prospectively-collected HCC patients with beyond-Milan criteria with \>6cm tumors were analyzed. 5-year OS of 76.2% was found in patients with both AFP \<200 ng/ml and GGT \<104 IU/mL with tumors less than 10 cm diameter. Thus, GGT values add to AFP in patient prognosis.

Background:A retrospective analysis was performed of prospectively-collected transplant data on outcomes of patients with large size HCCs,to examine possible prognostically-useful factors.Methods:A total of 50 patients having tumors greater than 6cm maximum diameter were identified. Their survival and full clinical characteristics were examined, with respect to serum AFP and GGT levels.Results:Using ROC analysis, cutoff values of AFP 200 ng/ml and GGT 104 IU/ml were identified and used in this study. Significantly longer overall-survival and disease-free-survival were found for patients who had lower values of either parameter, compared with higher values.Even greater differences in survival were found when the 2 parameters were combined, with best survival (5-year OS of 76,2% versus 0%, p=0.002).The most consistent clinical correlates for these longer survivals were degree of tumor differentiation and absence of microscopic portal venous invasion.Two tumor size bands were identified,to search for the limits of this approach with larger tumors, namely 6-10 and \>10cm.Combination parameters in 6-10cm band reflected 5-year OS of 76,2% vs. 0%,in patients with low AFP plus low GGT vs. other groups.Beyond 10cm,no patients had low AFP plus low GGT.Conclusions:AFP and GGT,both singly and together, represent a simple prognostic identifier for patients with large size HCCs being treated by liver transplantation.

Liver Transplant for Larger Hepatocellular Carcinoma in Malatya: The Role of GGT and AFP

Retrospective Cohort Study-Analysis of LT Patients With HCC (Maximum Tumor Diameter > 6 cm).

to analyse the factors that effect the survivals

MD, FEBS, Assoc.Prof

Central Nervous System Depressants

Antipyretics

Analgesics

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

Pharmaceutical Solutions

Antirheumatic Agents

Coagulants

Neuroprotective Agents

Anesthetics

Acetaminophen

Dexamethasone

Hydromorphone

Prednisolone

Anesthetics, Local

Dexamethasone acetate

Analgesics, Opioid

Ketorolac

Hemostatics

Methylprednisolone

Celecoxib

Methylprednisolone Acetate

Methylprednisolone Hemisuccinate

Prednisolone acetate

Prednisolone hemisuccinate

Prednisolone phosphate

Bismuth subsalicylate

Cyclooxygenase Inhibitors

Living Donor Liver Transplant patients with evidence based donor pain management solution.

Living Donor Liver Transplant patients prior to the implementation of the evidence based donor pain management solution.

The evidence-based donor pain management solution entails the following elements:

Preoperative Assessment and Management:

* Assessment of Patient Risk factors for Respiratory Depression (e.g. OSA Assessment: STOP BANG Questionnaire)
* Bowel preparation (e.g. Colace or Golytely)
* Patient Postoperative Pain Education - Educational handout on postoperative pain

At the end of the case in OR:

* Local Anesthetic (TAP block, OnQ device, intrathecal, local infiltration)
* I.V. Ketorolac (when adequate hemostasis is determined by surgeon and urine output is \> 500cc)
* I.V. Steroids (Dexamethasone or Solumedrol)

Postoperative Management:

* NSAIDS x 72 hours followed by po cox-inhibitor until discharge (e.g. Celecoxib)
* Opioids (Dilaudid PCA followed by oral opioids (e.g., Tylenol #3))

Postoperative Assessment:

o CO2 monitoring in PACU/ICU for early monitoring of respiratory depression

Donor pain management

Daniela Ladner, MD MPH

Donna Woods, PhD

Living donor liver transplantation (LDLT), involves complex systems and processes of care that are particularly vulnerable to medical errors and preventable complications. This ancillary study of the Adult-to-Adult Living Liver Transplantation Cohort Study (A2ALL) will focus on conducting a proactive, systematic, and comprehensive assessment of the vulnerabilities in the systems and process of LDLT care to reduce medical errors and preventable complications thereby improving the safety of LDLT care. This project will address an important gap in the knowledge needed to achieve high quality and safe LDLT care of patients by developing a process to: 1) proactively, systematically and comprehensively identify areas of vulnerabilities in LDLT care that can result in medical errors, 2) design and implement solutions to mitigate these weaknesses, and 3) evaluate the effectiveness of these solutions to improve the safety of LDLT care by measuring clinical and process outcomes before and after solution implementation across four A2ALL participating transplant centers

This is an observational as well as a time-controlled study to be conducted at four participating A2ALL Deux Transplant Centers (TCs). The study is divided into three phases: an observational phase (Aim 1) to conduct a comprehensive and proactive patient safety risk assessment to describe preventable complications, near miss events, medical errors and hazardous conditions and in the delivery of standard of care to living donor liver transplant (LDLT) donors and recipients from the time of admission for the LDLT surgery through discharge after LDLT surgery. The in depth observational phase continues throughout the study and is scheduled to be completed by the end of the study (May 2015).

In phase 2-solution development and implementation phase (Aim 2): two high priority areas of care were identified for in depth assessment and solution development. The selection of the two high priority areas of LDLT standard of care was guided by the identification of vulnerabilities in the systems and processes of care with a high incidence and severity of related preventable complications and medical errors across the four participating A2ALL Deux TCs. To date, multiple priority areas were identified, based on the ongoing review of medical records (e.g., transition of care, glucose control, donor pain management, preoperative OR set-up). The participating A2ALL Deux TCs agreed to focus on an in depth assessment of the two areas that demonstrated high incidence and high severity of preventable complications and medical errors: 1) donor pain management and 2) preoperative OR set-up process.

1. Donor Pain Management:

   Upon further investigation, it was identified that living liver donors experience significant amount of pain, in the early postoperative period but also especially a few days after donation. Data from the four participating A2ALL Deux TCs reveal a 20% incidence, overall, of respiratory complications (e.g. re-intubation, requirement for application of Naloxone, etc.) directly related to the opioid use in the present LDLT standard of care for donor pain management. Based on these data, clinicians at the four participating A2ALL Deux TCs, in consultation with an international pain expert with particular expertise in transplantation (Paul White, MD University of Texas Southwestern Medical Center at Dallas, Dallas, Texas), developed an evidence-based donor pain management solution with the aim of reducing preventable complications as well as improving the donor pain experience. This evidence-based donor pain management solution was developed over months through in-person and telephone meetings of transplant surgeons, hepatologists, anesthesiologists and acute pain specialists from all four participating A2ALL Deux TCs, in addition to the research teams. Consensus has been reached on the key elements of the evidence-based donor pain management solution and all four participating A2ALL Deux TCs are poised to begin implementation.
2. Preoperative OR Set-up Process:

Preventable complications, near miss events, medical errors and hazardous conditions related to the preoperative OR set-up processes were identified. The four participating A2ALL Deux TCs will need to engage in additional review of the detailed assessment of the standardization and optimization of the preoperative OR set-up process and then, will collaboratively design a standardized process over a four month period (expected conclusion mid February 2014 in order to incorporate what occurs at the Collaborative at each site and overall). Solutions will be designed collaboratively to reduce the incidence and severity of related medical errors and preventable complications together with the TCs and their staff.

The measurement of solution impact to reduce preventable complications and medical errors (Aim 3) involves the implementation of the two collaboratively developed solutions: (1) Evidence-based donor pain management solution and (2) Standardization and optimization of the preoperative OR set-up process. During this phase relevant metrics pre- and post-implementation will be compared to assess the effectiveness of the implemented solutions.

A2ALL-Patients Safety System Improvements in Living Donor Liver Transplantation

A2ALL-Patients Safety System Improvements in Living Donor Liver Transplant

Comparison of Average Pain Scores on Visual Analogue Pain Scale (0-10) measured before and after implementation of evidence-based donor pain management solution. 0 representing "No Pain", up through 10 representing "Worst possible, unbearable, excruciating pain".

Northwestern University

Assistant Professor

When this study was originally created, it was designed as an interventional study with planned adverse event collection for those events that were related to study interventions. The study designed was then revised to observational only, and therefore adverse events were not collected since there were no longer study interventions.

Post-Implementation Group

Pre-Implementation Group

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

This study was originally intended to be a clinical trial, with control and intervention sites, however, per discussions with the NIDDK program officer the study design was changed to a observational study.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Adult-to-Adult Living Donor Transplant Cohort Study	NCT01619475	Liver Diseases Hepatocellular ... End Stage Liver... Hepatitis C Liver Cirrhosis		18 Years -	Arbor Research Collaborative for Health
Comparison of Criteria for Liver Transplantation in Hepatocellular Carcinoma	NCT04576572	Hepatocellular ... Liver Cancer Advanced Adult ... Cirrhosis, Live... Unresectable Li... Liver Transplan...		-	Inonu University
Living Donor Liver Transplant for Unresectable Colorectal Liver Metastases	NCT05248581	Colorectal Canc...	Liver transplan...	18 Years -	University of Rochester
Living Donor Liver Transplant for Unresectable Colorectal Liver Metastases	NCT05248581	Colorectal Canc...	Liver transplan...	18 Years -	University of Rochester
Adult-to-Adult Living Donor Transplant Cohort Study	NCT01619475	Liver Diseases Hepatocellular ... End Stage Liver... Hepatitis C Liver Cirrhosis		18 Years -	Arbor Research Collaborative for Health
Liver Transplant for Larger Hepatocellular Carcinoma in Malatya: The Role of GGT and AFP	NCT04412161	Hepatocellular ... Liver Transplan...	Liver transplan...	-	Inonu University
A2ALL-Patients Safety System Improvements in Living Donor Liver Transplantation	NCT02073435	Liver Diseases Hepatocellular ... Endstage Liver ... Liver Cirrhosis	Donor pain mana...	21 Years - 60 Years	Northwestern University
Adult-to-Adult Living Donor Transplant Cohort Study	NCT01619475	Liver Diseases Hepatocellular ... End Stage Liver... Hepatitis C Liver Cirrhosis		18 Years -	Arbor Research Collaborative for Health
Living Donor Liver Transplant for Unresectable Colorectal Liver Metastases	NCT05248581	Colorectal Canc...	Liver transplan...	18 Years -	University of Rochester

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