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

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.

Conditions

• Chronic Hepatitis C
• Chronic Hepatitis B
• Biopsy
• Hemodialysis

Interventions

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)

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)

Sponsors & Collaborators

• National Science and Technology Council, Taiwan

  collaborator OTHER_GOV

• National Taiwan University Hospital

  lead OTHER

Principal Investigators

• Chen-Hua Liu, MD · National Taiwan University Hospital

• Jia-Horng Kao, MD · National Taiwan University Hospital

• Chun-Jen Liu, MD · National Taiwan University Hospital

• Ming-Yang Lai, MD · National Taiwan University Hospital

• Pei-Jer Chen, MD · National Taiwan University Hospital

• Ding-Shinn Chen, MD · National Taiwan University Hospital

• Cheng-Chao Liang, MD · Far Eastern Memorial Hospital

• Shih-Jer Hsu, MD · National Taiwan University Hospital, Yun-Lin Branch

• Jou-Wei Lin, MD · National Taiwan University Hospital, Yun-Lin Branch

• Shih-I Chen, MD · National Taiwan University Hospital, Yun-Lin Branch

• Hung-Bin Tsai, MD · St. Martin De Porres Hospital

• Peir-Haur Hung, MD · Chiayi Christian Hospital

• Jun-Herng Chen, MD · National Taiwan University Hospital, Yun-Lin Branch

Study Design

Allocation

NON_RANDOMIZED

Masking

NONE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2005-01-31

Primary Completion

2013-06-30

Completion

2013-07-31

Countries

• Taiwan

Study Locations