Clinical trial NCT04235855: 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
Overall status: COMPLETED
Phase: NA
Conditions: NAFLD
Alcoholic Hepatitis
Lead sponsor: Asian Institute of Gastroenterology, India
Sponsor class: OTHER
First posted: 2020-01-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Diagnostic yield with EUS guided liver biopsy .
timeFrame: 3 days
Secondary outcomes:
measure: Safety of procedure
timeFrame: 3 days
measure: Duration of procedure
timeFrame: 30 minutes
measure: Size of tissue acquired
timeFrame: 3 days
measure: Number of portal tracts
timeFrame: 3 days
measure: Post procedural complications
timeFrame: 3 days
measure: NAS score in fatty liver patients
timeFrame: 3 days
measure: Patient recovery time
timeFrame: 3 days
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Asian Institute of Gastroenterology Hospitals
state: Telangana
Study officials:
References:
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.
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.
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.