EUS Guided Liver Biopsy - Will it Give Better Yield, More Tissue With Less Complication?

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-31

Study Completion Date

2022-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Liver biopsy would be done by Endoscopic Ultrasound using Acquire needle.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

EUS-guided Versus Percutaneous Ultrasound-guided Biopsy for Parenchymal Liver Disease

NCT06047327

Liver Cirrhosis

COMPLETED NA

Efficacy of Endoscopic Ultrasound Guided Liver Biopsy Using Dynamic Wet Technique

NCT06833619

Efficacy of Endoscopic Ultrasound Guided Liver Biopsy Using Dynamic Wet Technique

RECRUITING NA

Wet Heparin for Obtaining Liver Tissue for EUS Guided Liver Biopsy

NCT03103997

Liver Diseases

COMPLETED NA

Prospective Single Centre Observational Study to Compare the Diagnostic Yield of Different Modalities of Liver Biopsy

NCT05912179

Liver Diseases Liver Fibrosis

UNKNOWN

Acoustic Liver Biopsy in Normals and in Patients With Cirrhosis Using Endoscopic Ultrasound

NCT01208311

Alcoholism Cirrhosis Hepatitis c

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

In this study, we aim to evaluate the tissue adequacy of EUS guided liver biopsy for parenchymal liver disease and to evaluate if diagnostic yield of left lobe is non-inferior to right lobe biopsies and to assess if combination biopsies have better yield than single lobe biopsies. Safety of the procedure and technical success would be noted.

The data would be analysed using SPSS software and needful variables and tests would be used as per statistical requirement.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

NAFLD Alcoholic Hepatitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

All liver biopsies done in the Institute as routine procedure by percutaneous route would be compared with the EUS guided biopsy in respect to safety , tissue quality and diagnostic yield.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

The biopsy specimens would be reported independently by two pathologists who would be masked to the source of tissue ( right/ left lobe ).

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Endoscopic USG guided Liver biopsy

Olympus linear echo endoscope (GF -UCT 180, Olympus Ltde, Tkyo, Japan) will be used. 19 Gz EUS Acquire needle Boston ©Scientific Corp will be used for liver tissue acquisition.

Group Type EXPERIMENTAL

Endoscopic USG guided Liver biopsy

Intervention Type DEVICE

Diagnostic yield with EUS guided liver biopsy - Left lobe Bx vs combined right and left lobe or vs right lobe would be assessed.

Percutaneous Liver biopsy

All liver biopsies done in the Institute as routine procedure by percutaneous route would be compared with the EUS guided biopsy in respect to safety , tissue quality and diagnostic yield .

Group Type ACTIVE_COMPARATOR

Percutaneous Liver Biopsy

Intervention Type DEVICE

All liver biopsies done in the Institute as routine procedure by percutaneous route would be compared with the EUS guided biopsy in respect to safety , tissue quality and diagnostic yield .

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Endoscopic USG guided Liver biopsy

Diagnostic yield with EUS guided liver biopsy - Left lobe Bx vs combined right and left lobe or vs right lobe would be assessed.

Intervention Type DEVICE

Percutaneous Liver Biopsy

All liver biopsies done in the Institute as routine procedure by percutaneous route would be compared with the EUS guided biopsy in respect to safety , tissue quality and diagnostic yield .

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients of any undiagnosed hepatic disease (after extensive investigation - serological as well as imaging) requiring a liver biopsy
* Patients of NAFLD who need liver biopsy
* Alcoholic hepatitis patients needing biopsy
* Any patient with unexplained transaminesemia \> 1.5 times ULN needing a liver biopsy as advised by Hepatologist

Exclusion Criteria

* Any liver Space occupying lesion suspicious of malignancy
* Platelet count \<80,000
* INR \> 1.5
* Pregnancy
* Severe cardiovascular and pulmonary diseases
* Recent use of anti-platelet agents within 5 days of the procedure
* Unwilling to provide informed consent

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No