Status:

UNKNOWN

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

Lead Sponsor:

National Taiwan University Hospital

Collaborating Sponsors:

National Science and Technology Council, Taiwan

Conditions:

Chronic Hepatitis C

Chronic Hepatitis B

Eligibility:

All Genders

Phase:

NA

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 ...

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 s...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

January 1 2005

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

July 1 2013

Estimated Enrollment :

3520 Patients enrolled

Trial Details

Trial ID

NCT00635310

Start Date

January 1 2005

End Date

July 1 2013

Last Update

December 20 2012

Active Locations (5)

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Page 1 of 2 (5 locations)

1

Chiayi Christian Hospital

Chiayi City, Taiwan

2

St. Martin De Porres Hospital

Chiayi City, Taiwan

3

National Taiwan University Hospital, Yun-Lin Branch

Douliu, Taiwan

4

Far Eastern Memorial Hospital

Taipei, Taiwan, 100