Safety Profiles of Liver Biopsy in Hemodialysis Patients With Chronic Viral Hepatitis Pre-treated With Vasopressin
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: HD patients with CHC or CHB Chronic hepatitis C (CHC) or chronic hepatitis B (CHB) patients with hemodialysis (HD), pretreated with DDAVP 0.3 ug/kg body weight infusion 30-60 minutes before percutaneous liver biopsies (PLBs) |
Procedure: Percutaneous liver biopsy
Two passes of PLB from the right hepatic lobe by US guidance (ToshibaTM PLF-308P, Toshiba Co. Ltd., Tokyo, Japan) and 16-gauge automatic cutting needles (Temno EvolutionTM, Allegiance, McGaw Park, IL, USA)
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| Active Comparator: Ordinary patients with CHC or CHB Chronic hepatitis C (CHC) or chronic hepatitis B (CHB) patients with normal renal function (NRF) receiving percutaneous liver biopsies (PLBs) |
Procedure: Percutaneous liver biopsy
Two passes of PLB from the right hepatic lobe by US guidance (ToshibaTM PLF-308P, Toshiba Co. Ltd., Tokyo, Japan) and 16-gauge automatic cutting needles (Temno EvolutionTM, Allegiance, McGaw Park, IL, USA)
|
Outcome Measures
Primary Outcome Measures
- Biopsy-related serious hemorrhage rate by intention-to-treat (ITT) analysis [14 days]
Secondary Outcome Measures
- Biopsy-related serious hemorrhage rate by per-protocol (PP) analysis [14 days]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Chronic hepatitis C (presence of anti-HCV and serum HCV RNA > 6 months)
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Chronic hepatitis B (presence of HBsAg > 6 months)
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Receiving regular hemodialysis or normal renal function (Creatinine < 1.5 x ULN)
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Receiving percutaneous liver biopsy (PLB)
Exclusion Criteria:
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Human immunodeficiency virus (HIV) co-infection
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Unwilling or contraindicated to receive percutaneous liver biopsy (PLB)
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Receiving liver biopsy without ultrasound (US) guidance or automatic cutting needles
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Did not receive 2 passes of liver biopsy
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Inadequate record of post-biopsy complications
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Chiayi Christian Hospital | Chia-Yi | Taiwan | ||
| 2 | St. Martin De Porres Hospital | Chia-Yi | Taiwan | ||
| 3 | National Taiwan University Hospital, Yun-Lin Branch | Douliou | Taiwan | ||
| 4 | Far Eastern Memorial Hospital | Taipei | Taiwan | 100 | |
| 5 | National Taiwan University Hospital | Taipei | Taiwan | 100 |
Sponsors and Collaborators
- National Taiwan University Hospital
- National Science Council, Taiwan
Investigators
- Principal Investigator: Chen-Hua Liu, MD, National Taiwan University Hospital
- Principal Investigator: Jia-Horng Kao, MD, National Taiwan University Hospital
- Principal Investigator: Chun-Jen Liu, MD, National Taiwan University Hospital
- Principal Investigator: Ming-Yang Lai, MD, National Taiwan University Hospital
- Principal Investigator: Pei-Jer Chen, MD, National Taiwan University Hospital
- Principal Investigator: Ding-Shinn Chen, MD, National Taiwan University Hospital
- Principal Investigator: Cheng-Chao Liang, MD, Far Eastern Memorial Hospital
- Principal Investigator: Shih-Jer Hsu, MD, National Taiwan University Hospital, Yun-Lin Branch
- Principal Investigator: Jou-Wei Lin, MD, National Taiwan University Hospital, Yun-Lin Branch
- Principal Investigator: Shih-I Chen, MD, National Taiwan University Hospital, Yun-Lin Branch
- Principal Investigator: Hung-Bin Tsai, MD, St. Martin De Porres Hospital
- Principal Investigator: Peir-Haur Hung, MD, Chiayi Christian Hospital
- Principal Investigator: Jun-Herng Chen, MD, National Taiwan University Hospital, Yun-Lin Branch
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 940211