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| Sponsors and Collaborators: |
National Taiwan University Hospital National Science Council, Taiwan |
|---|---|
| Information provided by: | National Taiwan University Hospital |
| ClinicalTrials.gov Identifier: | NCT00635310 |
Purpose
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-arginie 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 | Intervention |
|---|---|
|
Chronic Hepatitis C Chronic Hepatitis B Biopsy Hemodialysis |
Procedure: Percutaneous liver biopsy |
| Study Type: | Interventional |
| Study Design: | Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety Study |
| Official Title: | Safety Profiles of Percutaneous Liver Biopsy in Hemodialysis Patients With Chronic Hepatitis C Pre-Treated With 1-Deamino-8- D-Arginine Vasopressin |
| Estimated Enrollment: | 610 |
| Study Start Date: | January 2005 |
| Estimated Study Completion Date: | March 2009 |
| Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: 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)
|
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)
|
|
2: Active Comparator
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)
|
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 Willibrand 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| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Chen-Hua Liu, MD | +886-2-23123456 ext 3572 | jacque_liu@mail2000.com.tw |
| Taiwan | |
| National Taiwan University Hospital | Recruiting |
| Taipei, Taiwan, 100 | |
| Contact: Chen-Hua Liu, MD +886-2-23123456 ext 3572 jacque_liu@mail2000.com.tw | |
| Principal Investigator: 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 | |
| Far Eastern Memorial Hospital | Recruiting |
| Taipei, Taiwan, 100 | |
| Contact: Cheng-Chao Liang, MD | |
| Principal Investigator: Cheng-Chao Liang, MD | |
| National Taiwan University Hospital, Yun-Lin Branch | Recruiting |
| Douliou, Taiwan | |
| Contact: Shih-Jer Hsu, MD | |
| Principal Investigator: Shih-Jer Hsu, MD | |
| Principal Investigator: Jou-Wei Lin, MD | |
| Principal Investigator: Shih-I Chen, MD | |
| Principal Investigator: Jun-Herng Chen, MD | |
| St. Martin De Porres Hospital | Recruiting |
| Chia-Yi, Taiwan | |
| Contact: Hung-Bin Tsai, MD | |
| Principal Investigator: Hung-Bin Tsai, MD | |
| Chiayi Christian Hospital | Recruiting |
| Chia-Yi, Taiwan | |
| Contact: Peir-Haur Hung, MD | |
| Principal Investigator: Peir-Haur Hung, MD | |
| 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 |
More Information
| Responsible Party: | National Taiwan University Hospital ( Dr. Chen-Hua Liu ) |
| Study ID Numbers: | 940211 |
| Study First Received: | March 5, 2008 |
| Last Updated: | December 21, 2008 |
| ClinicalTrials.gov Identifier: | NCT00635310 |
| Health Authority: | Taiwan: Department of Health |
|
Chronic hepatitis C Chronic hepatitis B Liver biopsy Hemodialysis 1-Deamino-8- D-Arginine Vasopressin |
|
Liver Diseases Hepatitis, Chronic Hepatitis, Viral, Human Hepatitis Virus Diseases Arginine Vasopressin Digestive System Diseases |
Deamino Arginine Vasopressin Hepatitis B, Chronic Hepatitis B Vasopressins DNA Virus Infections Hepatitis C Hepatitis C, Chronic |
|
RNA Virus Infections Flaviviridae Infections Coagulants Physiological Effects of Drugs Hematologic Agents Cardiovascular Agents Hepadnaviridae Infections |
Pharmacologic Actions Hemostatics Natriuretic Agents Therapeutic Uses Vasoconstrictor Agents Antidiuretic Agents |
