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

• Sponsor: Asian Institute of Gastroenterology, India (Other)
• Overall Status: Completed
• CT.gov ID: NCT04235855
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Actual Duration (Months): 26.1
• Patients Per Site Per Month: 1.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
NAFLD; Alcoholic Hepatitis	Device: Endoscopic USG guided Liver biopsy; Device: Percutaneous Liver Biopsy	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention 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.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: Single (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 ).
• Primary Purpose: Diagnostic
• Official Title: EUS Guided Liver Biopsy Proposal Titled : EUS Guided Liver Biopsy - Will it Give Better Yield , More Tissue With Less Complication ?
• Actual Study Start Date: Oct 31, 2019
• Actual Primary Completion Date: Jan 1, 2022
• Actual Study Completion Date: Jan 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Device: 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.
Active Comparator: 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 .	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 .

Outcome Measures

Primary Outcome Measures

1. Diagnostic yield with EUS guided liver biopsy . [3 days]

   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

1. Safety of procedure [3 days]

   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 .

2. Duration of procedure [30 minutes]

   Time between start and end of the procedure would be noted .

3. Size of tissue acquired [3 days]

   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 .

4. Number of portal tracts [3 days]

   The adequacy of the sample would be assessed as per the AASLD and Royal College of Pathology definition (CPTs 11) .

5. Post procedural complications [3 days]

   Any procedure related complications such as pain (>6 on VAS) and bleeding would be noted .

6. NAS score in fatty liver patients [3 days]

   Difference in NAS score between right lobe and right vs left lobe in fatty liver patients

7. Patient recovery time [3 days]

   Patient recovery time when compared to per cutaneous liver biopsy procedure .

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Asian Institute of Gastroenterology Hospitals	Hyderabad	Telangana	India	500089

Sponsors and Collaborators

• Asian Institute of Gastroenterology, India

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.

• Responsible Party: Dr Mithun Sharma, Consultant Hepatologist, Asian Institute of Gastroenterology, India
• ClinicalTrials.gov Identifier: NCT04235855
• Other Study ID Numbers: ECR/346/Inst/AP/2013/RR-19
• First Posted: Jan 22, 2020
• Last Update Posted: Jan 4, 2022
• Last Verified: Jan 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hepatitis, Alcoholic; Liver Extracts

Study Results

No Results Posted as of Jan 4, 2022