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

Primary Purpose

NAFLD, Alcoholic Hepatitis

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Endoscopic USG guided Liver biopsy
Percutaneous Liver Biopsy
Sponsored by
Asian Institute of Gastroenterology, India
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for NAFLD

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Asian Institute of Gastroenterology Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Endoscopic USG guided Liver biopsy

Percutaneous Liver biopsy

Arm Description

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.

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 .

Outcomes

Primary Outcome Measures

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 .

Secondary Outcome Measures

Safety of procedure
Sedation related adverse effect will be monitored as per the institute protocol . Any type of bleed during procedure or needing additional intervention would be recorded as a major adverse effect .
Duration of procedure
Time between start and end of the procedure would be noted .
Size of tissue acquired
The length of the biopsy tissue would be ascertained immediately by onsite pathologist and would be assessed as per the AASLD and Royal College of Pathology definition .
Number of portal tracts
The adequacy of the sample would be assessed as per the AASLD and Royal College of Pathology definition (CPTs 11) .
Post procedural complications
Any procedure related complications such as pain (>6 on VAS) and bleeding would be noted .
NAS score in fatty liver patients
Difference in NAS score between right lobe and right vs left lobe in fatty liver patients
Patient recovery time
Patient recovery time when compared to per cutaneous liver biopsy procedure .

Full Information

First Posted
January 16, 2020
Last Updated
January 3, 2022
Sponsor
Asian Institute of Gastroenterology, India
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1. Study Identification

Unique Protocol Identification Number
NCT04235855
Brief Title
EUS Guided Liver Biopsy - Will it Give Better Yield, More Tissue With Less Complication?
Official Title
EUS Guided Liver Biopsy Proposal Titled : EUS Guided Liver Biopsy - Will it Give Better Yield , More Tissue With Less Complication ?
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
October 31, 2019 (Actual)
Primary Completion Date
January 1, 2022 (Actual)
Study Completion Date
January 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asian Institute of Gastroenterology, India

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Liver biopsy would be done by Endoscopic Ultrasound using Acquire needle.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NAFLD, Alcoholic Hepatitis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Outcomes Assessor
Masking Description
The biopsy specimens would be reported independently by two pathologists who would be masked to the source of tissue ( right/ left lobe ).
Allocation
Non-Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Endoscopic USG guided Liver biopsy
Arm Type
Experimental
Arm Description
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.
Arm Title
Percutaneous Liver biopsy
Arm Type
Active Comparator
Arm Description
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
Intervention Name(s)
Endoscopic USG guided Liver biopsy
Intervention Description
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
Intervention Name(s)
Percutaneous Liver Biopsy
Intervention Description
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 Outcome Measure Information:
Title
Diagnostic yield with EUS guided liver biopsy .
Description
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 .
Time Frame
3 days
Secondary Outcome Measure Information:
Title
Safety of procedure
Description
Sedation related adverse effect will be monitored as per the institute protocol . Any type of bleed during procedure or needing additional intervention would be recorded as a major adverse effect .
Time Frame
3 days
Title
Duration of procedure
Description
Time between start and end of the procedure would be noted .
Time Frame
30 minutes
Title
Size of tissue acquired
Description
The length of the biopsy tissue would be ascertained immediately by onsite pathologist and would be assessed as per the AASLD and Royal College of Pathology definition .
Time Frame
3 days
Title
Number of portal tracts
Description
The adequacy of the sample would be assessed as per the AASLD and Royal College of Pathology definition (CPTs 11) .
Time Frame
3 days
Title
Post procedural complications
Description
Any procedure related complications such as pain (>6 on VAS) and bleeding would be noted .
Time Frame
3 days
Title
NAS score in fatty liver patients
Description
Difference in NAS score between right lobe and right vs left lobe in fatty liver patients
Time Frame
3 days
Title
Patient recovery time
Description
Patient recovery time when compared to per cutaneous liver biopsy procedure .
Time Frame
3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Asian Institute of Gastroenterology Hospitals
City
Hyderabad
State/Province
Telangana
ZIP/Postal Code
500089
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
23916397
Citation
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.
Results Reference
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PubMed Identifier
19231495
Citation
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.
Results Reference
background
PubMed Identifier
27530070
Citation
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.
Results Reference
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EUS Guided Liver Biopsy - Will it Give Better Yield, More Tissue With Less Complication?

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