Clinical trial to study the Safety and Efficacy of EndoscopicUltrasound guided Liver Biopsy in patients with derranged coagulation profile

Not yet recruiting

Conditions: Liver disorders in diseases classified elsewhere,

Registration Number: CTRI/2022/07/043930

Lead Sponsor: Dr Praveer Rai

Brief Summary: Although various noninvasive markers are emerging, liver biopsy plays an important role

in the diagnosis, prognosis and therapeutic decision in various liver diseases. Various

routes for liver biopsy include percutaneous (PC), trans-jugular (TJ) and surgical.

Percutaneous liver biopsy is associated with complications like pain, life threatening

bleeding etc. By 1970s, trans-jugular liver biopsy emerged to overcome the

contraindications like coagulopathy and ascites of percutaneous route.

Introduction of Endoscopic ultrasound has changed the investigation and management

of gastric, pancreatic and hepatobiliary diseases. First case report of Endoscopic

Ultrasound guided liver biopsy was published in 2007. Since then various authors have

published case series in the last decade.

The PC and TJ methods have limited access to sample different areas of the liver, the EUS

method allows greater access to both hepatic lobes, increasing the adequacy and yield

of tissue. The EUS-LB provides clinicians with a real-time, detailed view of the biopsy

needle through the course of the liver and the trajectory can be changed if needed as

part of the â€œfanningâ€ technique to get a more representative sample. Multicenter

experience published by Diehl et al. (2015) showed that EUS liver biopsy have a high

safety profile and yield comparable to percutaneous route. In a retrospective analysis

Pineda et al (2016) have shown that EUS liver biopsy have significantly high yield as

compared to both percutaneous as well as trans-jugular route.

Previous studies have used either Tru-cut needle or FNA needle for liver Biopsy. In this

prospective study, our aim is to assess the safety and efficacy of EUS guided liver biopsy

using a 19-gauge FNB (fine needle biopsy) needle in coagulopathy patients

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

1.Adult Patients (Age>18 years) where liver biopsy is indicated 2.Those having coagulopathy or thrombocytopenia Coagulopathy is defined as INR>1.5 Thrombocytopenia is defined as Platelet count less than 1 lac/mm3.

Exclusion Criteria

1.Age<18 years 2.Pregnancy (confirmed with Standard of Care urine pregnancy test for all women with child-bearing potential only) 3.Inability to obtain Consent 4.Patient with INR >2.5 5.Patient with Platelet count below 30000/mm3 6.
Patients with known malignancy precluding liver biopsy 7.Patient with Sepsis 8.Patient diagnosed with Acute liver Failure 9.Patient with diagnosis of Obstructive Jaundice 10.Patient on Anticoagulation.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Outcomes;	1 year
â— Specimen quality for histological diagnosis in coagulopathy patient	1 year
be made based on the amount of tissue obtained in needle.	1 year
â— Specimen quality for histological diagnosis: Defined as histological diagnosis could	1 year
â— Portal Tract number: number of Complete Portal Tracts (CPTs)	1 year
â— Specimen length: Total Sample Length (TSL) and Longest sample Length (LSL)	1 year

Secondary Outcome Measures

Name	Time	Method
Adverse events;	1.Bleeding-not requiring blood transfusion

Trial Locations

Locations (1): SGPGIMS Lucknow
🇮🇳
Lucknow, UTTAR PRADESH, India
SGPGIMS Lucknow
🇮🇳Lucknow, UTTAR PRADESH, India
Dr Praveer Rai
Principal investigator
9530157095
praveer_rai@yahoo.com