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

December 19, 2012 updated by: National Taiwan University Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

3520

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Chia-Yi, Taiwan
        • Recruiting
        • Chiayi Christian Hospital
        • Contact:
          • Peir-Haur Hung, MD
        • Principal Investigator:
          • Peir-Haur Hung, MD
      • Chia-Yi, Taiwan
        • Recruiting
        • St. Martin De Porres Hospital
        • Contact:
          • Hung-Bin Tsai, MD
        • Principal Investigator:
          • Hung-Bin Tsai, MD
      • Douliou, Taiwan
        • Recruiting
        • National Taiwan University Hospital, Yun-Lin branch
        • Principal Investigator:
          • Jou-Wei Lin, MD
        • Principal Investigator:
          • Shih-I Chen, MD
        • Principal Investigator:
          • Jun-Herng Chen, MD
      • Taipei, Taiwan, 100
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
        • 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
      • Taipei, Taiwan, 100
        • Recruiting
        • Far Eastern Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Biopsy-related serious hemorrhage rate by intention-to-treat (ITT) analysis
Time Frame: 14 days
14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Biopsy-related serious hemorrhage rate by per-protocol (PP) analysis
Time Frame: 14 days
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Collaborators

National Science Council, Taiwan

Investigators

  • Principal Investigator: Pei-Jer Chen, MD, National Taiwan University Hospital
  • 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: Ding-Shinn Chen, MD, National Taiwan University Hospital
  • 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: Jun-Herng Chen, MD, National Taiwan University Hospital, Yun-Lin branch

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Anticipated)

June 1, 2013

Study Completion (Anticipated)

July 1, 2013

Study Registration Dates

First Submitted

March 5, 2008

First Submitted That Met QC Criteria

March 5, 2008

First Posted (Estimate)

March 13, 2008

Study Record Updates

Last Update Posted (Estimate)

December 20, 2012

Last Update Submitted That Met QC Criteria

December 19, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 940211

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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