NCT04235855

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 31, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 22, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

January 4, 2022

Status Verified

January 1, 2022

Enrollment Period

2.2 years

First QC Date

January 16, 2020

Last Update Submit

January 3, 2022

Conditions

NAFLDAlcoholic Hepatitis

Outcome Measures

Primary Outcomes (1)

  • Diagnostic yield with EUS guided liver biopsy .

    The diagnostic yield of a right lobe biopsy and left lobe biopsy would be compared to see if right lobe biopsy gives any additional information for diagnosis when compared to left lobe .

    3 days

Secondary Outcomes (7)

  • Safety of procedure

    3 days

  • Duration of procedure

    30 minutes

  • Size of tissue acquired

    3 days

  • Number of portal tracts

    3 days

  • Post procedural complications

    3 days

  • +2 more secondary outcomes

Study Arms (2)

Endoscopic USG guided Liver biopsy

EXPERIMENTAL

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.

Device: Endoscopic USG guided Liver biopsy

Percutaneous Liver biopsy

ACTIVE COMPARATOR

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 .

Device: Percutaneous Liver Biopsy

Interventions

Endoscopic USG guided Liver biopsyDEVICE

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

Endoscopic USG guided Liver biopsy
Percutaneous Liver BiopsyDEVICE

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 .

Percutaneous Liver biopsy

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asian Institute of Gastroenterology Hospitals

Hyderabad, Telangana, 500089, India

Location

Related Publications (3)

  • Gor N, Salem SB, Jakate S, Patel R, Shah N, Patil A. Histological adequacy of EUS-guided liver biopsy when using a 19-gauge non-Tru-Cut FNA needle. Gastrointest Endosc. 2014 Jan;79(1):170-2. doi: 10.1016/j.gie.2013.06.031. Epub 2013 Jul 31. No abstract available.

    PMID: 23916397BACKGROUND

  • Dewitt J, McGreevy K, Cummings O, Sherman S, Leblanc JK, McHenry L, Al-Haddad M, Chalasani N. Initial experience with EUS-guided Tru-cut biopsy of benign liver disease. Gastrointest Endosc. 2009 Mar;69(3 Pt 1):535-42. doi: 10.1016/j.gie.2008.09.056.

    PMID: 19231495BACKGROUND

  • Schulman AR, Thompson CC, Odze R, Chan WW, Ryou M. Optimizing EUS-guided liver biopsy sampling: comprehensive assessment of needle types and tissue acquisition techniques. Gastrointest Endosc. 2017 Feb;85(2):419-426. doi: 10.1016/j.gie.2016.07.065. Epub 2016 Aug 13.

    PMID: 27530070BACKGROUND

MeSH Terms

Conditions

Non-alcoholic Fatty Liver DiseaseHepatitis, Alcoholic

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System DiseasesHepatitisLiver Diseases, AlcoholicAlcohol-Induced DisordersAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The biopsy specimens would be reported independently by two pathologists who would be masked to the source of tissue ( right/ left lobe ).
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Hepatologist

Study Record Dates

First Submitted

January 16, 2020

First Posted

January 22, 2020

Study Start

October 31, 2019

Primary Completion

January 1, 2022

Study Completion

January 1, 2022

Last Updated

January 4, 2022

Record last verified: 2022-01

Locations

IN(1)