Safety Profiles of Liver Biopsy in Hemodialysis Patients With Chronic Viral Hepatitis Pre-Treated With Vasopressin - Full Text View

Sponsor:	National Taiwan University Hospital
Collaborator:	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:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus neurohypophyseal diabetes insipidus

MedlinePlus related topics: Diabetes Insipidus Dialysis Hepatitis Hepatitis A Hepatitis B Hepatitis C

Drug Information available for: Vasopressins Desmopressin Desmopressin acetate Arginine Argipressin Hepatitis A Vaccines Arginine hydrochloride

U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:

Biopsy-related serious hemorrhage rate by intention-to-treat (ITT) analysis [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Biopsy-related serious hemorrhage rate by per-protocol (PP) analysis [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	610
Study Start Date:	January 2005
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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) Other Name: Percutaneous liver biopsy
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) Other Name: Percutaneous liver biopsy

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 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

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00635310

Contacts

Contact: Chen-Hua Liu, MD

+886-2-23123456 ext 3572

jacque_liu@mail2000.com.tw

Locations

Taiwan
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
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
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

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

No publications provided

Responsible Party:	Dr. Chen-Hua Liu, National Taiwan University Hospital
ClinicalTrials.gov Identifier:	NCT00635310 History of Changes
Other Study ID Numbers:	940211
Study First Received:	March 5, 2008
Last Updated:	June 8, 2009
Health Authority:	Taiwan: Department of Health

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:

Diabetes Insipidus
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
Hepatitis C
Hepatitis B, Chronic
Hepatitis C, Chronic
Kidney Diseases
Urologic Diseases
Pituitary Diseases
Endocrine System Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human

Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Flaviviridae Infections
Arginine Vasopressin
Vasopressins
Deamino Arginine Vasopressin
Liver Extracts
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 12, 2012