Safety Profiles of Liver Biopsy in Hemodialysis Patients With Chronic Viral Hepatitis Pre-treated With Vasopressin
Information source: National Taiwan University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Hepatitis C; Chronic Hepatitis B; Biopsy; Hemodialysis
Intervention: Percutaneous liver biopsy (Procedure); Percutaneous liver biopsy (Procedure)
Phase: N/A
Status: Recruiting
Sponsored by: National Taiwan University Hospital Official(s) and/or principal investigator(s):
Chen-Hua Liu, MD, Principal Investigator, Affiliation: National Taiwan University Hospital
Jia-Horng Kao, MD, Principal Investigator, Affiliation: National Taiwan University Hospital
Chun-Jen Liu, MD, Principal Investigator, Affiliation: National Taiwan University Hospital
Ming-Yang Lai, MD, Principal Investigator, Affiliation: National Taiwan University Hospital
Pei-Jer Chen, MD, Principal Investigator, Affiliation: National Taiwan University Hospital
Ding-Shinn Chen, MD, Principal Investigator, Affiliation: National Taiwan University Hospital
Cheng-Chao Liang, MD, Principal Investigator, Affiliation: Far Eastern Memorial Hospital
Shih-Jer Hsu, MD, Principal Investigator, Affiliation: National Taiwan University Hospital, Yun-Lin Branch
Jou-Wei Lin, MD, Principal Investigator, Affiliation: National Taiwan University Hospital, Yun-Lin Branch
Shih-I Chen, MD, Principal Investigator, Affiliation: National Taiwan University Hospital, Yun-Lin Branch
Hung-Bin Tsai, MD, Principal Investigator, Affiliation: St. Martin De Porres Hospital
Peir-Haur Hung, MD, Principal Investigator, Affiliation: Chiayi Christian Hospital
Jun-Herng Chen, MD, Principal Investigator, Affiliation: National Taiwan University Hospital, Yun-Lin Branch
Overall contact:
Chen-Hua Liu, MD, Phone: +886-2-23123456, Ext: 3572, Email: jacque_liu@mail2000.com.tw
Summary
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.
Clinical Details
Official title: Safety Profiles of Percutaneous Liver Biopsy in Hemodialysis Patients With Chronic Hepatitis C Pre-treated With 1-Deamino-8- D-Arginine Vasopressin
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label
Primary outcome: Biopsy-related serious hemorrhage rate by intention-to-treat (ITT) analysis
Secondary outcome: Biopsy-related serious hemorrhage rate by per-protocol (PP) analysis
Detailed description:
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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Chronic hepatitis C (presence of anti-HCV and serum HCV RNA > 6 months)
- Chronic hepatitis B (presence of HBsAg > 6 months)
- Receiving regular hemodialysis or normal renal function (Creatinine < 1. 5 x ULN)
- Receiving percutaneous liver biopsy (PLB)
Exclusion Criteria:
- Human immunodeficiency virus (HIV) co-infection
- Unwilling or contraindicated to receive percutaneous liver biopsy (PLB)
- Receiving liver biopsy without ultrasound (US) guidance or automatic cutting needles
- Did not receive 2 passes of liver biopsy
- Inadequate record of post-biopsy complications
Locations and Contacts
Chen-Hua Liu, MD, Phone: +886-2-23123456, Ext: 3572, Email: jacque_liu@mail2000.com.tw
Chiayi Christian Hospital, Chia-Yi, Taiwan; Recruiting
Peir-Haur Hung, MD
Peir-Haur Hung, MD, Principal Investigator
St. Martin De Porres Hospital, Chia-Yi, Taiwan; Recruiting
Hung-Bin Tsai, MD
Hung-Bin Tsai, MD, Principal Investigator
National Taiwan University Hospital, Yun-Lin Branch, Douliou, Taiwan; Recruiting
Shih-Jer Hsu, MD
Shih-Jer Hsu, MD, Principal Investigator
Jou-Wei Lin, MD, Principal Investigator
Shih-I Chen, MD, Principal Investigator
Jun-Herng Chen, MD, Principal Investigator
Far Eastern Memorial Hospital, Taipei 100, Taiwan; Recruiting
Cheng-Chao Liang, MD
Cheng-Chao Liang, MD, Principal Investigator
National Taiwan University Hospital, Taipei 100, Taiwan; Recruiting
Chen-Hua Liu, MD, Phone: +886-2-23123456, Ext: 3572, Email: jacque_liu@mail2000.com.tw
Chen-Hua Liu, MD, Principal Investigator
Jia-Horng Kao, MD, Principal Investigator
Chun-Jen Liu, MD, Principal Investigator
Ming-Yang Lai, MD, Principal Investigator
Pei-Jer Chen, MD, Principal Investigator
Ding-Shinn Chen, MD, Principal Investigator
Additional Information
Starting date: January 2005
Last updated: December 19, 2012
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