Safety and efficacy of transjugular biopsy using Endoscopic Ultrasound Fine Needle

JRCT ID: jRCT1032200111

Registered date:09/09/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Chronic hepatitis or Renal disorder
• Date of first enrollment: 02/11/2020
• Target sample size: 12
• Study type: Interventional
• Intervention(s): Transjugular biopsy using EUS-FNA needle biopsy device

Outcome(s)

• Primary Outcome: Incidence of serious adverse events causally related to the biopsy

Secondary Outcome

Incidence of non-serious adverse events causally related to the biopsy
Degree of pain
Success rate
Amount of tissue collected
Diagnostic capability
Procedure time, a needle length of EUS-FNA

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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.

Exclude criteria

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.

Related Information

• Primary Sponsor: Kato Naoya