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

NAFLD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04235855
• Other study ID #: ECR/346/Inst/AP/2013/RR-19
• Status: Completed
• Phase: N/A
• Start date: October 31, 2019
• Est. completion date: January 1, 2022

Study information

• Verified date: January 2022
• Source: Asian Institute of Gastroenterology, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcoholic Hepatitis
• Hepatitis, Alcoholic
• NAFLD

Intervention

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.
• 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 .

Locations

Country	Name	City	State
India	Asian Institute of Gastroenterology Hospitals	Hyderabad	Telangana

Sponsors (1)

Lead Sponsor	Collaborator
Asian Institute of Gastroenterology, India

Country where clinical trial is conducted

India, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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 .	3 days
Secondary	Duration of procedure	Time between start and end of the procedure would be noted .	30 minutes
Secondary	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 .	3 days
Secondary	Number of portal tracts	The adequacy of the sample would be assessed as per the AASLD and Royal College of Pathology definition (CPTs 11) .	3 days
Secondary	Post procedural complications	Any procedure related complications such as pain (>6 on VAS) and bleeding would be noted .	3 days
Secondary	NAS score in fatty liver patients	Difference in NAS score between right lobe and right vs left lobe in fatty liver patients	3 days
Secondary	Patient recovery time	Patient recovery time when compared to per cutaneous liver biopsy procedure .	3 days