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

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ClinicalTrials.gov Identifier: NCT00635310
Recruitment Status : Unknown
Verified December 2012 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : March 13, 2008
Last Update Posted : December 20, 2012
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by (Responsible Party):
National Taiwan University Hospital

Tracking Information
First Submitted Date  ICMJE March 5, 2008
First Posted Date  ICMJE March 13, 2008
Last Update Posted Date December 20, 2012
Study Start Date  ICMJE January 2005
Estimated Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 14, 2008)
Biopsy-related serious hemorrhage rate by intention-to-treat (ITT) analysis [ Time Frame: 14 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 5, 2008)
Biopsy-related serious hemorrhage rate [ Time Frame: 14 days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 14, 2008)
Biopsy-related serious hemorrhage rate by per-protocol (PP) analysis [ Time Frame: 14 days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2008)
Mild hemorrhage rate without hospitalization [ Time Frame: 14 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Profiles of Liver Biopsy in Hemodialysis Patients With Chronic Viral Hepatitis Pre-treated With Vasopressin
Official Title  ICMJE Safety Profiles of Percutaneous Liver Biopsy in Hemodialysis Patients With Chronic Hepatitis C Pre-treated With 1-Deamino-8- D-Arginine Vasopressin
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE
  • Chronic Hepatitis C
  • Chronic Hepatitis B
  • Biopsy
  • Hemodialysis
Intervention  ICMJE 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)
Study Arms  ICMJE
  • 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)
    Intervention: Procedure: 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)
    Intervention: Procedure: Percutaneous liver biopsy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 19, 2012)
3520
Original Estimated Enrollment  ICMJE
 (submitted: March 5, 2008)
686
Estimated Study Completion Date  ICMJE July 2013
Estimated Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00635310
Other Study ID Numbers  ICMJE 940211
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Taiwan University Hospital
Study Sponsor  ICMJE National Taiwan University Hospital
Collaborators  ICMJE National Science Council, Taiwan
Investigators  ICMJE
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
PRS Account National Taiwan University Hospital
Verification Date December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP