Safety and efficacy of transjugular biopsy using Endoscopic Ultrasound Fine Needle
- Conditions
- Chronic hepatitis or Renal disorder
- Registration Number
- JPRN-jRCT1032200111
- Lead Sponsor
- Kato Naoya
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 12
1) Patients who scheduled for a transvenous liver biopsy or transvenous renal biopsy due to chronic liver disease with/without renal impairment
2) Child-Pugh score A or B
3) Age is 20 years or older (any gender)
4) Patients who have been fully informed of and have obtained the written consent of their own free will to participate in the study.
1) The patient who has one of the following cardiac diseases
a) Heart failure of NYHA class 3 or higher.
b) Current symptomatic coronary artery disease or a history of myocardial infarction within 4 weeks prior to enrollment.
2) Serious and active infection (CTCAE version 4.0 Grade 3 or higher)
3) Pregnant or lactating women and those who may or will become pregnant (if pregnancy is suspected, a pregnancy test should be performed).
4) There is a possibility of compromising patient safety or difficulty in complying with the study protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of serious adverse events causally related to the biopsy
- Secondary Outcome Measures
Name Time Method Incidence of non-serious adverse events causally related to the biopsy<br>Degree of pain<br>Success rate<br>Amount of tissue collected<br>Diagnostic capability<br>Procedure time, a needle length of EUS-FNA