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  1. Article ; Online: Posttransplant biopsy risk for stable long-term pediatric liver transplant recipients: 451 percutaneous biopsies from two multicenter immunosuppression withdrawal trials.

    Perito, Emily R / Martinez, Mercedes / Turmelle, Yumirle P / Mason, Kristen / Spain, Katharine M / Bucuvalas, John C / Feng, Sandy

    American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons

    2019  Volume 19, Issue 5, Page(s) 1545–1551

    Abstract: Although liver biopsy is the gold standard for assessing allograft health, its attendant risk has deterred its use in routine monitoring of stable liver transplant recipients during long-term follow-up. We utilized prospectively collected data on adverse ...

    Abstract Although liver biopsy is the gold standard for assessing allograft health, its attendant risk has deterred its use in routine monitoring of stable liver transplant recipients during long-term follow-up. We utilized prospectively collected data on adverse events from 2 clinical trials of immunosuppression withdrawal to quantify the risk of liver biopsy in pediatric liver transplant recipients. The trials included 451 liver biopsies in 179 children. No biopsies led to bleeding requiring transfusion or intervention, suggesting a clinically significant bleeding risk of <0.8%. Complications were reported in 5.5% of biopsies (95% CI 3.6%-8.1%): 5.8% (21/363) of protocol biopsies and 4.5% (4/88) of for-cause biopsies (P = .80). Mild complications occurred in 1.8% of biopsies, moderate in 1.8%, and severe in 2.0%. The majority of complications (89%) resolved within 1 week. Six of 9 (67%) severe complications were related to biliary issues; 5 were episodes of cholangitis. Biopsy-related cholangitis occurred only in children with underlying biliary strictures. Overall, biopsy-related complications were infrequent and resolved quickly. Severe complications were rare, with occult biliary stricture as the dominant driver. Our study provides evidence for clinicians who are considering the risk vs benefit of surveillance liver biopsies in pediatric liver transplant recipients.
    MeSH term(s) Child ; Female ; Follow-Up Studies ; Graft Rejection/etiology ; Graft Rejection/pathology ; Graft Survival/immunology ; Humans ; Immune Tolerance/immunology ; Immunosuppression Therapy/statistics & numerical data ; Immunosuppressive Agents/therapeutic use ; Infant ; Liver Transplantation/adverse effects ; Male ; Postoperative Complications ; Prognosis ; Prospective Studies ; Risk Factors ; Transplantation, Homologous ; Withholding Treatment
    Chemical Substances Immunosuppressive Agents
    Language English
    Publishing date 2019-02-04
    Publishing country United States
    Document type Clinical Trial ; Journal Article ; Multicenter Study ; Research Support, N.I.H., Extramural
    ZDB-ID 2060594-8
    ISSN 1600-6143 ; 1600-6135
    ISSN (online) 1600-6143
    ISSN 1600-6135
    DOI 10.1111/ajt.15255
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

    Zs.A 5542: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (2.OG)
    ab Jg. 2022: Lesesaal (EG)

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  2. Article ; Online: Five-year histological and serological follow-up of operationally tolerant pediatric liver transplant recipients enrolled in WISP-R.

    Feng, Sandy / Demetris, Anthony J / Spain, Katharine M / Kanaparthi, Sai / Burrell, Bryna E / Ekong, Udeme D / Alonso, Estella M / Rosenthal, Philip / Turka, Laurence A / Ikle, David / Tchao, Nadia K

    Hepatology (Baltimore, Md.)

    2017  Volume 65, Issue 2, Page(s) 647–660

    Abstract: Pediatric liver transplant recipients arguably have the most to gain and the most to lose from discontinuing immunosuppression (IS). Whereas IS undoubtedly exerts a cumulative toll, there is concern that insufficient or no IS may contribute to allograft ... ...

    Abstract Pediatric liver transplant recipients arguably have the most to gain and the most to lose from discontinuing immunosuppression (IS). Whereas IS undoubtedly exerts a cumulative toll, there is concern that insufficient or no IS may contribute to allograft deterioration. Twelve pediatric recipients of parental living donor liver grafts, identified as operationally tolerant through complete IS withdrawal (WISP-R; NCT00320606), were followed for a total of 5 years (1 year of IS withdrawal and 4 years off IS) with serial liver tests and autoantibody and alloantibody assessments. Liver biopsies were performed 2 and 4 years off IS, and, at these time points, immunoglobulin G (IgG) subclass and C1q binding activity for donor-specific antibodies (DSAs) were determined. There were no cases of chronic rejection, graft loss, or death. Allografts did not exhibit progressive increase in inflammation or fibrosis. Smooth-muscle actin expression by stellate cells and CD34 expression by liver sinusoidal endothelial cells remained stable, consistent with the absence of progressive graft injury. Three subjects never exhibited DSA. However, 3 subjects showed intermittent de novo class I DSA, 4 subjects showed persistent de novo class II DSA, and 5 subjects showed persistent preexisting class II DSA. Class II DSA was predominantly against donor DQ antigens, often of high mean fluorescence intensity, rarely of the IgG3 subclass, and often capable of binding C1q.
    Conclusion: Operationally tolerant pediatric liver transplant recipients maintain generally stable allograft histology in spite of apparently active humoral allo-immune responses. The absence of increased inflammation or progressive fibrosis suggests that a subset of liver allografts seem resistant to the chronic injury that is characteristic of antibody-mediated damage. (Hepatology 2017;65:647-660).
    MeSH term(s) Allografts ; Biopsy, Needle ; Child ; Child, Preschool ; Female ; Follow-Up Studies ; Graft Rejection ; Graft Survival ; Humans ; Immunoglobulin G/immunology ; Immunohistochemistry ; Immunosuppressive Agents/administration & dosage ; Isoantibodies/immunology ; Liver Diseases/congenital ; Liver Diseases/pathology ; Liver Diseases/surgery ; Liver Transplantation/adverse effects ; Liver Transplantation/methods ; Living Donors ; Male ; Prospective Studies ; Risk Assessment ; Time Factors ; Transplantation Immunology ; Treatment Outcome
    Chemical Substances Immunoglobulin G ; Immunosuppressive Agents ; Isoantibodies
    Language English
    Publishing date 2017-02
    Publishing country United States
    Document type Journal Article ; Multicenter Study ; Randomized Controlled Trial
    ZDB-ID 604603-4
    ISSN 1527-3350 ; 0270-9139
    ISSN (online) 1527-3350
    ISSN 0270-9139
    DOI 10.1002/hep.28681
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

    Zs.A 1660: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (1.OG)
    ab Jg. 2022: Lesesaal (EG)

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    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

  3. Article ; Online: Efficacy and Safety of Immunosuppression Withdrawal in Pediatric Liver Transplant Recipients: Moving Toward Personalized Management.

    Feng, Sandy / Bucuvalas, John C / Mazariegos, George V / Magee, John C / Sanchez-Fueyo, Alberto / Spain, Katharine M / Lesniak, Andrew / Kanaparthi, Sai / Perito, Emily / Venkat, Veena L / Burrell, Bryna E / Alonso, Estella M / Bridges, Nancy D / Doo, Edward / Gupta, Nitika A / Himes, Ryan W / Ikle, David / Jackson, Annette M / Lobritto, Steven J /
    Jose Lozano, Juan / Martinez, Mercedes / Ng, Vicky L / Rand, Elizabeth B / Sherker, Averell H / Sundaram, Shikha S / Turmelle, Yumirle P / Wood-Trageser, Michele / Demetris, Anthony J

    Hepatology (Baltimore, Md.)

    2020  Volume 73, Issue 5, Page(s) 1985–2004

    Abstract: Background and aims: Tolerance is transplantation's holy grail, as it denotes allograft health without immunosuppression and its toxicities. Our aim was to determine, among stable long-term pediatric liver transplant recipients, the efficacy and safety ... ...

    Abstract Background and aims: Tolerance is transplantation's holy grail, as it denotes allograft health without immunosuppression and its toxicities. Our aim was to determine, among stable long-term pediatric liver transplant recipients, the efficacy and safety of immunosuppression withdrawal to identify operational tolerance.
    Approach and results: We conducted a multicenter, single-arm trial of immunosuppression withdrawal over 36-48 weeks. Liver tests were monitored biweekly (year 1), monthly (year 2), and bimonthly (years 3-4). For-cause biopsies were done at investigators' discretion but mandated when alanine aminotransferase or gamma glutamyltransferase exceeded 100 U/L. All subjects underwent final liver biopsy at trial end. The primary efficacy endpoint was operational tolerance, defined by strict biochemical and histological criteria 1 year after stopping immunosuppression. Among 88 subjects (median age 11 years; 39 boys; 57 deceased donor grafts), 33 (37.5%; 95% confidence interval [CI] 27.4%, 48.5%) were operationally tolerant, 16 were nontolerant by histology (met biochemical but failed histological criteria), and 39 were nontolerant by rejection. Rejection, predicted by subtle liver inflammation in trial entry biopsies, typically (n = 32) occurred at ≤32% of the trial-entry immunosuppression dose and was treated with corticosteroids (n = 32) and/or tacrolimus (n = 38) with resolution (liver tests within 1.5 times the baseline) for all but 1 subject. No death, graft loss, or chronic, severe, or refractory rejection occurred. Neither fibrosis stage nor the expression level of a rejection gene set increased over 4 years for either tolerant or nontolerant subjects.
    Conclusions: Immunosuppression withdrawal showed that 37.5% of selected pediatric liver-transplant recipients were operationally tolerant. Allograft histology did not deteriorate for either tolerant or nontolerant subjects. The timing and reversibility of failed withdrawal justifies future trials exploring the efficacy, safety, and potential benefits of immunosuppression minimization.
    MeSH term(s) Child ; Child, Preschool ; Female ; Graft Rejection/epidemiology ; Graft Rejection/etiology ; Humans ; Immunosuppressive Agents/administration & dosage ; Immunosuppressive Agents/adverse effects ; Immunosuppressive Agents/therapeutic use ; Infant ; Liver Transplantation/adverse effects ; Liver Transplantation/methods ; Male ; Precision Medicine/methods ; Prospective Studies ; Withholding Treatment
    Chemical Substances Immunosuppressive Agents
    Language English
    Publishing date 2020-10-08
    Publishing country United States
    Document type Journal Article ; Multicenter Study ; Research Support, N.I.H., Extramural
    ZDB-ID 604603-4
    ISSN 1527-3350 ; 0270-9139
    ISSN (online) 1527-3350
    ISSN 0270-9139
    DOI 10.1002/hep.31520
    Database MEDical Literature Analysis and Retrieval System OnLINE

    Full text online

    More links

    Kategorien

    In stock of ZB MED Cologne/Königswinter

    Zs.A 1660: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (1.OG)
    ab Jg. 2022: Lesesaal (EG)

    Order via subito

    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

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