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Safety and efficacy of transjugular biopsy using Endoscopic Ultrasound Fine Needle

Safety and efficacy of transjugular biopsy using the AcquireTM Endoscopic Ultrasound Fine Needle Biopsy Device

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1032200111
Enrollment
12
Registered
2020-09-09
Start date
2020-11-02
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic hepatitis or Renal disorder

Interventions

Transjugular biopsy using EUS-FNA needle biopsy device

Sponsors

Kato Naoya
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

MeasureTime frame
Incidence of serious adverse events causally related to the biopsy

Secondary

MeasureTime frame
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

Contacts

Public ContactTakayuki Kondo

Chiba University Hospital

takakon@chiba-u.jp+81-43-222-7171

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026