Safety Profiles of Liver Biopsy in Hemodialysis Patients With Chronic Viral Hepatitis Pre-treated With Vasopressin

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Chronic Hepatitis C; Chronic Hepatitis B; Biopsy; Hemodialysis	Procedure: Percutaneous liver biopsy	Not Applicable

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

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	3520 participants
Allocation:	Non-Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
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 Start Date :	January 2005
Estimated Primary Completion Date :	June 2013
Estimated Study Completion Date :	July 2013

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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)
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

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Primary Outcome Measures :

1. Biopsy-related serious hemorrhage rate by intention-to-treat (ITT) analysis [ Time Frame: 14 days ]

Secondary Outcome Measures :

1. Biopsy-related serious hemorrhage rate by per-protocol (PP) analysis [ Time Frame: 14 days ]

Eligibility Criteria

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Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Chen-Hua Liu, MD	+886-2-23123456 ext 3572	jacque_liu@mail2000.com.tw

Locations

Taiwan
Chiayi Christian Hospital	Recruiting
Chia-Yi, Taiwan
Contact: Peir-Haur Hung, MD
Principal Investigator: Peir-Haur Hung, MD
St. Martin De Porres Hospital	Recruiting
Chia-Yi, Taiwan
Contact: Hung-Bin Tsai, MD
Principal Investigator: Hung-Bin Tsai, 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
Far Eastern Memorial Hospital	Recruiting
Taipei, Taiwan, 100
Contact: Cheng-Chao Liang, MD
Principal Investigator: Cheng-Chao Liang, MD
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

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	National Taiwan University Hospital
ClinicalTrials.gov Identifier:	NCT00635310 History of Changes
Other Study ID Numbers:	940211
First Posted:	March 13, 2008
Last Update Posted:	December 20, 2012
Last Verified:	December 2012

Keywords provided by National Taiwan University Hospital:

Chronic hepatitis C; Chronic hepatitis B; Liver biopsy; Hemodialysis; 1-Deamino-8- D-Arginine Vasopressin

Additional relevant MeSH terms:

Hepatitis; Hepatitis A; Hepatitis C; Hepatitis, Chronic; Hepatitis B; Hepatitis C, Chronic; Hepatitis B, Chronic; Liver Diseases; Digestive System Diseases; Hepatitis, Viral, Human; Virus Diseases; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections	Flaviviridae Infections; Hepadnaviridae Infections; DNA Virus Infections; Liver Extracts; Vasopressins; Arginine Vasopressin; Deamino Arginine Vasopressin; Hematinics; Hemostatics; Coagulants; Vasoconstrictor Agents; Antidiuretic Agents; Natriuretic Agents; Physiological Effects of Drugs