John P Roberts

St. Elizabeth's Medical Center, Boston, Massachusetts, United States

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Publications (200)1185.98 Total impact

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    ABSTRACT: We propose that some deceased donor kidneys be allocated to initiate non-simultaneous extended altruistic donor chains of living donor kidney transplants to address in part the huge disparity between patients on the deceased donor kidney waitlist and available donors. The use of deceased donor kidneys for this purpose would benefit waitlisted candidates in that most patients enrolled in kidney paired donation systems are also waitlisted for a deceased donor kidney transplant and receiving a kidney through the mechanism of kidney paired donation will decrease pressure on the deceased donor pool. In addition, a living donor kidney usually provides survival potential equal or superior to that of deceased donor kidneys. If kidney paired donation chains that are initiated by a deceased donor can end in a donation of a living donor kidney to a candidate on the deceased donor waitlist, the quality of the kidney allocated to waitlisted patient is likely to be improved. We hypothesize that a pilot program would show a positive impact on patients of all ethnicities and blood types. This article is protected by copyright. All rights reserved.
    No preview · Article · Feb 2016 · American Journal of Transplantation
  • Justin Parekh · Nancy L. Ascher · John P. Roberts

    No preview · Article · Dec 2015 · Liver Transplantation

  • No preview · Article · Dec 2015 · Progress in transplantation (Aliso Viejo, Calif.)

  • No preview · Article · Dec 2015 · Gastroenterology
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    ABSTRACT: Thank you for your interest in our work. We intended for the clinician assessment tool to facilitate the difficult conversation between clinicians and patients about the risk of death with end-stage liver disease. This is particularly important for cirrhotics awaiting liver transplantation, many of whom are so focused on the goal of transplant that they, understandably, deny the fact that they could get too sick for transplant. While the MELD score can provide us with the statistics - i.e., "At your MELD score, you have a 25% risk of death in the next 90 days" - do our patients really understand that? Our sense is that what they hear is, "You have a 75% chance of being alive", when every clinician knows that a 25% risk of death in 90 days is extraordinarily high. This article is protected by copyright. All rights reserved.
    No preview · Article · Nov 2015 · Liver international: official journal of the International Association for the Study of the Liver
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    ABSTRACT: Patients with T1 hepatocellular carcinoma (HCC) (1 lesion < 2 cm) are currently not eligible for priority listing for liver transplant (LT). A common practice is to wait without loco-regional therapy (LRT) until tumor growth from T1 to T2 (1 lesion 2-5 cm or 2-3 lesions ≤3 cm) to be eligible for listing with MELD exception. We aimed to evaluate the intention-to-treat outcome of the “wait and not ablate” approach for non-resection candidates with T1 HCC until tumor growth to T2. The study included 114 patients with T1 HCC 1.0-1.9 cm followed by serial imaging every 3 months. Two investigators performed independent imaging reviews to confirm the diagnosis. Median increase in total tumor diameter was 0.14 cm/month. Probabilities of progression from T1 to directly beyond T2 without LT listing were 4.4% at 6 months and 9.0% at both 12 and 24 months. The 1- and 3-year survival was 94.5% and 75.5%. In multivariate analysis, predictors of rapid tumor progression, defined as a >1 cm increase in total tumor diameter over 3 months, included alcoholic liver disease (HR 6.32, p=0.02) and Hispanic race (HR 3.81, p=0.049), whereas hepatitis B appeared to be protective (HR 0.08, p=0.04). By competing risks regression, predictors of exclusion from LT (with or without listing for LT under T2) were AFP >500 ng/mL (HR 12.7, 95% CI 2.8-57.0; p=0.001) and rapid tumor progression (HR 5.7, p<0.001). Conclusion: The “wait and not ablate” approach until tumor growth from T1 to T2 before LT listing is associated with a <10% risk of tumor progression to directly beyond T2 criteria. However, patients with AFP >500 ng/mL and rapid tumor progression are at high risk for wait list dropout and should receive early LRT. This article is protected by copyright. All rights reserved.
    No preview · Article · Oct 2015 · Liver Transplantation
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    ABSTRACT: The Model for End-Stage Liver Disease (MELD) score, which estimates mortality within 90 days, determines priority for liver transplantation (LT). However, longer-term outcomes on the waitlist for patients who are initially listed with low MELD scores are not well-characterized. All adults listed for primary liver transplantation at a single, high-volume center from 2005-12 with an initial laboratory MELD 22 or lower were evaluated. Excluded were those listed with MELD exception points, who underwent living donor LT (LDLT) or transplant at another center, or who were removed from the waitlist for non-medical reasons. Outcomes and causes of death were identified by UNOS, the National Death Index, and an electronic medical record review. Multivariable competing risk analysis evaluated predictors of death compared to deceased donor LT (DDLT). 893 patients were listed from 2005-12. By the end of follow-up, 27% had undergone DDLT, and 31% were removed from the waitlist for death or clinical deterioration. In competing risks assessment, only MELD 6-9, older age, lower serum albumin, lower BMI, and diabetes conferred increased risk of waitlist dropout compared to DDLT. Listing for SLK was protective against waitlist dropout. 275 patients died or were delisted for being too sick; 87% of the identifiable causes of death were directly related to end-stage liver disease or hepatocellular carcinoma. Patients with low listing MELD scores remain at significant risk for death due to liver-related causes and may benefit from early access to transplantation, such as LDLT or acceptance of high-risk donor livers. Predictors of death compared to transplantation may allow for early identification of patients who are at risk for waitlist mortality. This article is protected by copyright. All rights reserved. © 2015 American Association for the Study of Liver Diseases.
    No preview · Article · Aug 2015 · Liver Transplantation
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    David A Axelrod · Parsia A Vagefi · John P Roberts
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    ABSTRACT: The liver transplant allocation system has evolved to a ranking system of "sickest-first" system based on objective criteria. Yet, organs continue to be distributed first within OPOs and regions that are largely based on historical practice patterns related to kidney transplantation and were never designed to minimize waitlist death or equalize opportunity for liver transplant. The current proposal is a move to enhance survival though the application of modern mathematical techniques to optimize liver distribution. Like MELDbased allocation, it will never be perfect and should be continually evaluated and revised. However, the disparity in access, which favors those residing in or able to travel to privileged areas, to the detriment of the patients dying on the list in underserved areas, is simply not defensible in 2015.
    Full-text · Article · Aug 2015 · Annals of surgery
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    ABSTRACT: Delayed graft function, which is reported in up to 50% of kidney-transplant recipients, is associated with increased costs and diminished long-term graft function. The effect that targeted mild hypothermia in organ donors before organ recovery has on the rate of delayed graft function is unclear. We enrolled organ donors (after declaration of death according to neurologic criteria) from two large donation service areas and randomly assigned them to one of two targeted temperature ranges: 34 to 35°C (hypothermia) or 36.5 to 37.5°C (normothermia). Temperature protocols, which were initiated after authorization was obtained for the organ to be donated and for the donor's participation in the study, ended when organ donors left the intensive care unit for organ recovery in the operating room. The primary outcome was delayed graft function in the kidney recipients, which was defined as the requirement for dialysis during the first week after transplantation. Secondary outcomes were the rates of individual organs transplanted in each treatment group and the total number of organs transplanted from each donor. The study was terminated early, on the recommendation of an independent data and safety monitoring board, after the interim analysis showed efficacy of hypothermia. At trial termination, 370 organ donors had been enrolled (180 in the hypothermia group and 190 in the normothermia group). A total of 572 patients received a kidney transplant (285 kidneys from donors in the hypothermia group and 287 kidneys from donors in the normothermia group). Delayed graft function developed in 79 recipients of kidneys from donors in the hypothermia group (28%) and in 112 recipients of kidneys from donors in the normothermia group (39%) (odds ratio, 0.62; 95% confidence interval, 0.43 to 0.92; P=0.02). Mild hypothermia, as compared with normothermia, in organ donors after declaration of death according to neurologic criteria significantly reduced the rate of delayed graft function among recipients. (Funded by the Health Resources and Services Administration; ClinicalTrials.gov number, NCT01680744.).
    No preview · Article · Jul 2015 · New England Journal of Medicine
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    ABSTRACT: Previous studies on loco{\hyphen}regional therapy (LRT) and alpha{\hyphen}fetoprotein (AFP) in predicting outcome after liver transplant (LT) for hepatocellular carcinoma (HCC) have shown inconsistent results. We analyzed the OPTN database in Region 5 from January 2004 to January 2009, and performed univariate and multivariate analysis of 11 pre{\hyphen}transplant recipient and donor variables in 1074 patients with HCC meeting Milan criteria to detect association with post{\hyphen}LT tumor recurrence or mortality. Mean waitlist time was 438 days. The 1{\hyphen} and 5{\hyphen}year post{\hyphen}LT survival was 91.1{\percnt} and 71.1{\percnt}, respectively. In multivariate analysis, AFP before LT was the only predictor of HCC recurrence. The association between AFP and HCC recurrence was observed only in the subgroup receiving LRT but not in the subgroup without LRT. Predictors of mortality in multivariate analysis were HCC recurrence, Donor Risk Index, last AFP before LT, and MELD score. AFP before LT was the strongest predictor of post{\hyphen}transplant HCC recurrence or death in multivariate analysis. In conclusion, in Region 5 with prolonged waitlist time, high AFP was the only pre{\hyphen}transplant variable predicting post{\hyphen}transplant tumor recurrence and mortality for HCC meeting Milan criteria. Our results also supported the importance of the effects of LRT on AFP in predicting prognosis. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.
    No preview · Article · Mar 2015 · Clinical Transplantation
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    ABSTRACT: We report long-term intention-to-treat outcome of 118 patients with hepatocellular carcinoma (HCC) undergoing down-staging to within Milan/UNOS T2 criteria before liver transplantation (LT) since 2002, and compare the results with 488 patients listed for LT with HCC meeting T2 criteria at listing in the same period. The down-staging subgroups include 1 lesion >5 cm and ≤8 cm (n=43), 2 or 3 lesions at least one >3 cm and ≤5 cm with total tumor diameter ≤8 cm (n=61), or 4 to 5 lesions each ≤3 cm with total tumor diameter ≤8 cm (n=14). In the down-staging group, 64 patients (54.2%) had received LT, and 5 (7.5%) developed HCC recurrence. Two of the 5 patients with HCC recurrence had 4-5 tumors at presentation. The 1- and 2-year cumulative probabilities for dropout (competing risk) were 24.1% and 34.2% in the down-staging group, versus 20.3% and 25.6% in the T2 group (p=0.04). The Kaplan-Meier 5-year post-transplant survival and recurrence-free probabilities were 77.8% and 90.8%, respectively, in the down-staging group, versus 81% and 88%, respectively, in the T2 group (p=0.69 and p=0.66, respectively). The 5-year intention-to-treat survival was 56.1% in the down-staging group, versus 63.3% in the T2 group (p=0.29). Factors predicting dropout in the down-staging group included pre-treatment alpha-fetoprotein ≥1000 ng/mL (multivariate HR 2.42, p=0.02) and Child's B versus Child's A cirrhosis (multivariate HR 2.19, p=0.04). Conclusion: Successful down-staging of HCC to within T2 criteria was associated with a low rate of HCC recurrence and excellent post-transplant survival, comparable to those meeting T2 criteria without down-staging. Due to the small number of patients with 4-5 tumors, further investigations are needed to confirm the efficacy of down-staging in this subgroup. This article is protected by copyright. All rights reserved. © 2015 by the American Association for the Study of Liver Diseases.
    No preview · Article · Feb 2015 · Hepatology
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    ABSTRACT: Background & aims: The US liver allocation system effectively prioritizes most liver transplant candidates by disease severity as assessed by the Model for End-Stage Liver Disease (MELD) score. Yet, one in five dies on the wait-list. We aimed to determine whether clinician assessments of health status could identify this subgroup of patients at higher risk for wait-list mortality. Methods: From 2012-2013, clinicians of all adult liver transplant candidates with laboratory MELD≥12 were asked at the clinic visit: 'How would you rate your patient's overall health today (0 = excellent, 5 = very poor)?' The odds of death/delisting for being too sick for the transplant by clinician-assessment score ≥3 vs. <3 were assessed by logistic regression. Results: Three hundred and forty-seven liver transplant candidates (36% female) had a mean follow-up of 13 months. Men differed from women by disease aetiology (<0.01) but were similar in age and markers of liver disease severity (P > 0.05). Mean clinician assessment differed between men and women (2.3 vs. 2.6; P = 0.02). The association between clinician-assessment and MELD was ρ = 0.28 (P < 0.01). 53/347 (15%) died/were delisted. In univariable analysis, a clinician-assessment score ≥ 3 was associated with increased odds of death/delisting (2.57; 95% CI 1.42-4.66). After adjustment for MELD and age, a clinician-assessment score ≥ 3 was associated with 2.25 (95% CI 1.22-4.15) times the odds of death/delisting compared to a clinician-assessment score < 3. Conclusions: A standardized clinician assessment of health status can identify liver transplant candidates at high risk for wait-list mortality independent of MELD score. Objectifying this 'eyeball test' may inform interventions targeted at this vulnerable subgroup to optimize wait-list outcomes.
    No preview · Article · Jan 2015 · Liver international: official journal of the International Association for the Study of the Liver
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    ABSTRACT: A subset of liver transplant (LT) recipients who undergo transplant for hepatocellular carcinoma (HCC) will develop post-operative recurrence. There has yet to be a thorough investigation of donor factors influencing recurrence. Data regarding adult, primary LT recipients with HCC (n=5002) transplanted between January 1, 2006 and September 30, 2010 were extracted from United Network for Organ Sharing (UNOS) database, with subsequent estimation of the cumulative incidence of post-LT recurrence by donor factors. Of the HCC LT recipients, 324 (6.5%) developed recurrence. Analysis of donor characteristics demonstrated a higher cumulative incidence of recurrence within 4 years of transplant among recipients of donors ≥60 years old (versus donors <60 years old) (11.8% versus 7.3%, respectively; p<0.001), and donors from non-local share distribution (versus local share distribution) (10.6% versus 7.4%, respectively; p=0.004). The latter two findings held true on multivariable analysis with HCC recurrence risk increased by 70% for recipients of donor livers ≥60 years old (SHR=1.70, 95% CI 1.31-2.20, p<0.001) and by 42% for recipients of non-local share distribution (SHR=1.42, 95% CI 1.09-1.84, p=0.009) after adjusting for clinical characteristics. In conclusion, consideration of certain donor factors may reduce the cumulative incidence of post-transplant HCC recurrence, and thus improve long-term survival following LT. Liver Transpl , 2014. © 2014 AASLD.
    No preview · Article · Nov 2014 · Liver Transplantation
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    ABSTRACT: Liver transplant allocation policy does not give MELD exception points for patients with a single hepatocellular carcinoma (HCC) less than 2cm in size, but does give points to patients with multiple small nodules. Because standard-of-care imaging for HCC struggles to differentiate HCC from other nodules, it is possible that a subset of patients receiving liver transplant for multiple nodules <2cm in size do not have HCC.We evaluate risk of post-transplant HCC recurrence and waitlist dropout for patients with multiple small nodules using competing risks regression based on the Fine and Gray model.We identified 5002 adult HCC patients in the OPTN/UNOS dataset diagnosed and transplanted between January 2006 and September 2010. Compared to patients with >1 tumor <2cm, risk of developing recurrence was significantly higher in patients with 1 or more tumors with only 1 tumor ≥2cm (SHR 1.63, p=0.009), as well as in patients with 2-3 tumors ≥2cm (SHR 1.84, p=0.02). Dropout risk was not significantly different among size categories.HCC recurrence risk was significantly lower in patients with multiple nodules <2cm in size than in those with larger tumors, supporting the possibility that some patients received unnecessary transplants. The priority given to these patients must be re-examined.This article is protected by copyright. All rights reserved.
    No preview · Article · Nov 2014 · Clinical Transplantation
  • Francis Y. Yao · Bilal Hameed · Neil Mehta · John P. Roberts

    No preview · Article · Oct 2014 · Liver Transplantation
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    ABSTRACT: Serum alpha-fetoprotein (AFP) has been increasingly recognized as a marker for poor prognosis after liver transplant (LT) for hepatocellular carcinoma (HCC). Many published reports, however, included a large proportion of HCC beyond Milan criteria, and the effects of incorporating AFP as an exclusion criterion for LT remain unclear. We studied 211 consecutive patients receiving LT for HCC within Milan criteria by imaging under the MELD organ allocation system between June 2002 and January 2009. The majority (93.4%) had loco-regional therapy before LT. The median follow-up was 4.5 years (minimum > 2 years). The Kaplan-Meier 1- and 5-year patient survival was 94.3% and 83.4%. In univariate analysis, significant predictors of HCC recurrence included vascular invasion (HR 10.0, 95% CI 3.9-26, p<0.0001), pathologic tumor stage beyond UCSF criteria (HR 4.1, 95% CI 3.9-26, p=0.012), AFP >1000 ng/mL (HR 4.5, 95% CI 1.3-15.4, p=0.018); and AFP >500 ng/mL (HR 3.1, 95% CI 1.04-9.4, p=0.043). In multivariate analysis, vascular invasion was the only significant predictor of tumor recurrence (HR 4.5, 95% CI 1.3-15.4, p=0.018). AFP >1000 ng/mL was the strongest pre-transplant variable predicting vascular invasion (Odds ratio 6.8, 95% CI 1.6-19.1, p=0.006). The 1- and 5-year survival without recurrence for patients with AFP >1000 ng/mL was 90% and 52.7%, respectively, vs. 95% and 80.3% for AFP <=1000 ng/mL (p=0.01). Applying an AFP cutoff of >1000 ng/mL would have resulted in exclusion of 4.7% of patients from LT, and a 20% reduction in HCC recurrence. In conclusion, AFP >1000 ng/mL may be a surrogate for vascular invasion and predicts post-transplant HCC recurrence. Incorporating AFP >1000 ng/mL as an exclusion criterion for LT using Milan criteria may further improve post-transplant outcome. Liver Transpl , 2014. © 2014 AASLD.
    No preview · Article · Aug 2014 · Liver Transplantation
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    ABSTRACT: Background: Geographic disparity in access to liver transplantation (LT) exists. This study sought to examine Model for End-Stage Liver Disease-era multiply listed (ML) LT candidate (ie, candidates who list at 2 or more LT centers to receive a liver transplant). Study design: Data on adult, primary, non-status 1 LT candidates (n = 59,557) listed from January 1, 2005 to December 31, 2011 were extracted from the United Network for Organ Sharing's Standard Transplant Analysis and Research files. Comparisons of ML vs singly listed LT candidates were performed, with additional analysis performed at the donor service area (DSA) and regional level, as well as assessment of the donor population used. Results: There were 1,358 (2.3%) ML candidates during the 7-year study period. Multiply listed candidates compared with singly listed candidates were more often male, white, blood type O, nondiabetic, college educated, and privately insured. The odds of pursuing ML increased considerably as time on the waitlist increased. Of the ML candidates, 918 (67.6%) went on to receive a liver transplant (ML-LT), 767 (83.6%) at the secondary listing DSA, which was a median of 588 miles (range 229 to 1095 miles) from the primary listing DSA. When compared with the primary listing DSA, the secondary listing DSA had significantly lower match Model for End-Stage Liver Disease scores, as well as shorter wait times. Regional analysis demonstrated significantly higher odds for pursuing ML from LT candidates located within regions 1, 5, and 9. Conclusions: A small and distinctive cohort of LT candidates pursue ML, indicating willingness and means to travel to receive a liver transplant. Efforts toward equalizing LT access across regional disparities are warranted, and can help obviate the need for ML.
    No preview · Article · May 2014 · Journal of the American College of Surgeons
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    ABSTRACT: Background Geographic disparity in access to liver transplantation (LT) exists. This study sought to examine the MELD era multiply-listed (ML) LT candidate- candidates who list at two or more LT centers in order to achieve LT. Study Design Data regarding adult, primary (1°), non-status 1, LT candidates (n=59,557) listed from 1/1/05 to 12/31/11 were extracted from UNOS STAR files. Comparisons of ML versus singly listed (SL) LT candidates were performed, with further analysis performed at the Donor Service Area (DSA) and regional level, as well as assessment of the donor population utilized. Results There were 1,358 (2.3%) ML candidates during the 7 year study period. ML compared to SL candidates were more often male, white, blood type O, non-diabetic, college educated, and privately insured. The odds of pursuing ML significantly increased as time on the waitlist increased. Of the ML candidates, 918 (67.6%) went on to receive a LT (ML-LT), 767 (83.6%) at the 2° listing DSA which was a median (IQR) of 588 miles (229-1095) from the 1° listing DSA. When compared to the 1° listing DSA, the 2° listing DSA had significantly lower match MELD scores as well as shorter wait times. Regional analysis demonstrated significantly higher odds for pursuing ML from LT candidates located within Regions 1, 5, and 9. Conclusions A small and distinctive cohort of LT candidates pursue ML, indicating willingness and means to travel to achieve LT. Efforts towards equalizing LT access across regional disparities are warranted, and may help obviate the need for ML.
    No preview · Article · Jan 2014 · Journal of the American College of Surgeons
  • Eitan Neidich · Alon B Neidich · David A Axelrod · John P Roberts

    No preview · Article · Nov 2013 · The virtual mentor : VM
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    ABSTRACT: Mycophenolate mofetil (MMF) and sirolimus (SRL) have been used for calcineurin inhibitor (CNI) minimization to reduce nephrotoxicity after liver transplantation. In this prospective, open-label, multicenter study, patients undergoing transplantation from July 2005 to June 2007 who were maintained on MMF/CNI were randomized 4 to 12 weeks after transplantation to receive MMF/SRL (n = 148) or continue MMF/CNI (n = 145). The primary efficacy endpoints were the mean percentage change in the calculated glomerular filtration rate (GFR) and a composite of biopsy-proven acute rejection (BPAR), graft loss, death, and loss to follow-up 12 months after transplantation. Patients were followed for a median of 519 days after randomization. MMF/SRL was associated with a significantly greater renal function improvement from the baseline with a mean percentage change in GFR of 19.7 ± 40.6 (versus 1.2 ± 39.9 for MMF/CNI, P = 0.002). The composite endpoint demonstrated the noninferiority of MMF/SRL versus MMF/CNI (16.4% versus 15.4%, 90% confidence interval = -7.1% to 9.0%). The incidence of BPAR was significantly greater with MMF/SRL (12.2%) versus MMF/CNI (4.1%, P = 0.02). Graft loss (including death) occurred in 3.4% of the MMF/SRL-treated patients and in 8.3% of the MMF/CNI-treated patients (P = 0.04). Malignancy-related deaths were less frequent with MMF/SRL. Adverse events caused withdrawal for 34.2% of the MMF/SRL-treated patients and for 24.1% of the MMF/CNI-treated patients (P = 0.06). The use of MMF/SRL is an option for liver transplant recipients who can benefit from improved renal function but is associated with an increased risk of rejection (but not graft loss). Liver Transpl, 2013. © 2013 AASLD.
    Preview · Article · Jul 2013 · Liver Transplantation

Publication Stats

9k Citations
1,185.98 Total Impact Points

Institutions

  • 2015
    • St. Elizabeth's Medical Center
      Boston, Massachusetts, United States
  • 1990-2015
    • University of California, San Francisco
      • • Division of Transplant Surgery
      • • Department of Surgery
      • • Division of Gastroenterology
      San Francisco, California, United States
  • 2010
    • University of Nebraska Medical Center
      • Department of Surgery
      Omaha, Nebraska, United States
  • 1997-2002
    • Massachusetts General Hospital
      Boston, Massachusetts, United States
  • 2000
    • Universidade de Passo Fundo
      Passo Fundo, Rio Grande do Sul, Brazil
  • 1996
    • University of California, Davis
      Davis, California, United States
  • 1992
    • University of California, Los Angeles
      • Department of Anesthesiology
      Los Ángeles, California, United States