Clinical trial NCT00635310: Safety Profiles of Liver Biopsy in Hemodialysis Patients With Chronic Viral Hepatitis Pre-treated With Vasopressin
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Hepatitis C
Chronic Hepatitis B
Biopsy
Hemodialysis
Keywords: Chronic hepatitis C
Chronic hepatitis B
Liver biopsy
Hemodialysis
1-Deamino-8- D-Arginine Vasopressin
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2008-03-13
Enrollment: 3520
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

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.

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.

Eligibility 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

Primary outcomes:
measure: Biopsy-related serious hemorrhage rate by intention-to-treat (ITT) analysis
timeFrame: 14 days
Secondary outcomes:
measure: Biopsy-related serious hemorrhage rate by per-protocol (PP) analysis
timeFrame: 14 days
Other outcomes:
Locations:
city: Chia-Yi
country: Taiwan
facility: Chiayi Christian Hospital
city: Chia-Yi
country: Taiwan
facility: St. Martin De Porres Hospital
city: Douliou
country: Taiwan
facility: National Taiwan University Hospital, Yun-Lin Branch
city: Taipei
country: Taiwan
facility: Far Eastern Memorial Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Chen-Hua Liu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Taiwan University Hospital
name: Jia-Horng Kao, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Taiwan University Hospital
name: Chun-Jen Liu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Taiwan University Hospital
name: Ming-Yang Lai, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Taiwan University Hospital
name: Pei-Jer Chen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Taiwan University Hospital
name: Ding-Shinn Chen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Far Eastern Memorial Hospital
name: Cheng-Chao Liang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Taiwan University Hospital, Yun-Lin Branch
name: Shih-Jer Hsu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Taiwan University Hospital, Yun-Lin Branch
name: Jou-Wei Lin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Taiwan University Hospital, Yun-Lin Branch
name: Shih-I Chen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Martin De Porres Hospital
name: Hung-Bin Tsai, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chiayi Christian Hospital
name: Peir-Haur Hung, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Taiwan University Hospital, Yun-Lin Branch
name: Jun-Herng Chen, MD
role: PRINCIPAL_INVESTIGATOR
References: