Chronic Hepatitis B Clinical Trial
Official title:
Safety Profiles of Percutaneous Liver Biopsy in Hemodialysis Patients With Chronic Hepatitis C Pre-treated With 1-Deamino-8- D-Arginine Vasopressin
Percutaneous liver biopsy (PLB) is the gold standard for grading necroinflammation and staging fibrosis in patients with chronic viral hepatitis. Whether the use of 1-deamino-8-D-arginine vasopressin (DDAVP) before PLBs in hemodialysis (HD) patients with chronic viral hepatitis has comparable safety profiles to those with normal renal function (NRF) has not been evaluated in prospective studies.
Chronic viral hepatitis is common in dialysis patients, with the reported prevalence and
annual incidence of 3-80% and 2.9%, respectively. Currently, percutaneous liver biopsy (PLB)
remains the gold standard for grading necroinflammation and staging fibrosis in patients
with liver diseases. In addition, liver histology can help clinicians determine the
eligibility of renal transplantation, prognosis, and necessity of antiviral therapy in
dialysis patients with chronic viral hepatitis. In chronic hepatitis patients with normal
renal function (NRF), the risks of fatal and non-fatal hemorrhage after liver biopsies for
non-malignant diseases were 0.04% and 0.16%, respectively. However, the relative risks of
post-biopsy hemorrhage in CHC patients with end-stage renal disease to those with NRF remain
disputed.
Deamino-8-D-arginine vasopressin (DDAVP), a synthetic analogue of vasopressin, is a commonly
used hemostatic agent to treat uremic bleeding by inducing the release of von Willebrand
factor (vWF) and factor VIII from their storage sites in endothelial cells.Previous studies
have shown that one dose of 0.3-0.4μg/kg body weight DDAVP infusion for dialysis patients
could normalize bleeding time (BT), and prevent surgical and renal biopsy bleeding.
Nevertheless, two recent studies showed divergent liver biopsy-related bleeding complication
rates (0% and 6%, respectively) in dialysis CHC patients pre-treated with DDAVP. Since most
studies evaluating the safety of PLB in CHC patients with dialysis were small and
retrospective in nature, and not controlled by the biopsy route, the type of biopsy needle,
the use of ultrasound guidance, or the number of passes,further studies are urgently needed
to solve this important issue. Thus, we aimed to conducted a large clinical trial to compare
the safety profiles of PLB between CHC patients with hemodialysis (HD) who were pretreated
with DDAVP and those with NRF by the same biopsy technique.
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Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label
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