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

Chronic Hepatitis B Clinical Trial

Official title:

Safety Profiles of Percutaneous Liver Biopsy in Hemodialysis Patients With Chronic Hepatitis C Pre-treated With 1-Deamino-8- D-Arginine Vasopressin

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00635310
• Other study ID #: 940211
• Status: Recruiting
• Phase: N/A
• First received: March 5, 2008
• Last updated: December 19, 2012
• Start date: January 2005
• Est. completion date: July 2013

Study information

• Verified date: December 2012
• Source: National Taiwan University Hospital
• Contact: Chen-Hua Liu, MD
• Phone: +886-2-23123456
• Email: jacque_liu[@]mail2000.com.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3520
• Est. completion date: July 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Biopsy
• Chronic Hepatitis B
• Chronic Hepatitis C
• Diabetes Insipidus
• Hemodialysis
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

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)
• 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)

Locations

Country	Name	City	State
Taiwan	Chiayi Christian Hospital	Chia-Yi
Taiwan	St. Martin De Porres Hospital	Chia-Yi
Taiwan	National Taiwan University Hospital, Yun-Lin Branch	Douliou
Taiwan	Far Eastern Memorial Hospital	Taipei
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan University Hospital	National Science Council, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biopsy-related serious hemorrhage rate by intention-to-treat (ITT) analysis		14 days	Yes
Secondary	Biopsy-related serious hemorrhage rate by per-protocol (PP) analysis		14 days	Yes