An interventional study of Percutaneous Liver Biopsy in Brain Death and Liver Disease, sponsored by Rutgers, The State University of New Jersey. Terminated at 2 sites in United States. Per ClinicalTrials.gov, last updated 2015-05-13.
Sponsored by Rutgers, The State University of New Jersey · Not applicable, Interventional, and Diagnostic
This study's objective is to obtain preliminary data to test the hypotheses that percutaneous liver biopsy in brain death donors is safe and provides reliable histological information. Furthermore, that information when disseminated fully and widely many hours before organ recovery would not only decrease economic costs of wasteful recovery of livers that are not ultimately transplanted but also increase transplantation and decrease cold ischemia times of recovered livers.
2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.
This study's enrollment of 6 is below the median of 50 across 1,323 interventional studies indexed under Liver Diseases.
Browse Liver Diseases studies →Rutgers, The State University of New Jersey is the lead sponsor of 496 studies on the registry; 130 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 30 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
High risk donor, as defined by the following criteria i) Known liver disease ii) Hepatitis BsAg, BcAb, B DNA, Hepatitis C Ab or Hepatitis C RNA positivity iii) Age >= 50 iv) Any of the following risk factors for fatty liver disease a) BMI >= 30 b) History of Type 2 Diabetes Mellitus c) Ultrasound, Computerized Tomography or other imaging modalities suggesting steatosis v) Any of the following risk factors for chronic liver disease
Exclusion Criteria:
In this group a liver biopsy will not be performed. All management would be as per standard of practice
In this group a percutaneous biopsy of the liver will be performed prior to organ recovery
Procedure: Percutaneous Liver Biopsy
Using a 16 gauge Jamshidi biopsy needle, without image guidance, 3 passes will be completed to obtain core liver biopsies. Biopsies will be placed on wet saline and processed via frozen sample in OCT compound in 5 micron slices and stained with hematoxylin and eosin for microscopic evaluation. Slides will then be digitalized and shared on Donor.net.
Also known as: Bedside Liver Biopsy
Safety
Safety of bedside liver biopsy will be measured as the presence or absence of a composite outcome of: change in hemoglobin (gm/dL) from baseline of greater than 2, occurence of pneumothorax on right side observed on chest X-ray immediately after biopsy, and/or donor instability leading to expedited organ recover, and/or loss of donor organs attributed to the biopsy
Time frame: 6 hours
Reliability
Agreement of the findings of the bedside biopsy with reference to an intraoperative biopsy in histological characteristics of steatosis, inflammation, and fibrosis
Time frame: 24hrs
Feasibility
The proportion of donors in the biopsy group in whom PPB information becomes available prior to commencement of organ recovery
Time frame: 24hrs
Feasibility
Time between performance of biopsy and availability of results to the sharing network
Time frame: 24hrs
This study is terminated, as verified in May 2015. You cannot join it, but the record below documents what was studied.
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Rutgers, The State University of New Jersey