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| Name | Class |
|---|---|
| National Science and Technology Council, Taiwan | OTHER_GOV |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HD patients with CHC or CHB | Active Comparator | 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) |
|
| Ordinary patients with CHC or CHB | Active Comparator | Chronic hepatitis C (CHC) or chronic hepatitis B (CHB) patients with normal renal function (NRF) receiving percutaneous liver biopsies (PLBs) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous liver biopsy | Procedure | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Biopsy-related serious hemorrhage rate by intention-to-treat (ITT) analysis | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Biopsy-related serious hemorrhage rate by per-protocol (PP) analysis | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chen-Hua Liu, MD | Contact | +886-2-23123456 | 3572 | jacque_liu@mail2000.com.tw |
| Name | Affiliation | Role |
|---|---|---|
| Chen-Hua Liu, MD | National Taiwan University Hospital | Principal Investigator |
| Jia-Horng Kao, MD | National Taiwan University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chiayi Christian Hospital | Recruiting | Chiayi City | Taiwan |
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| Percutaneous liver biopsy | Procedure | 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) |
|
| 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 | Principal Investigator |
| St. Martin De Porres Hospital | Recruiting | Chiayi City | Taiwan |
|
| National Taiwan University Hospital, Yun-Lin Branch | Recruiting | Douliu | Taiwan |
|
| Far Eastern Memorial Hospital | Recruiting | Taipei | 100 | Taiwan |
|
| National Taiwan University Hospital | Recruiting | Taipei | 100 | Taiwan |
|
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006509 | Hepatitis B |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
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