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CTRI Number  CTRI/2022/07/043930 [Registered on: 12/07/2022] Trial Registered Prospectively
Last Modified On: 04/07/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Safety and Efficacy of Endoscopic Ultrasound guided Liver Biopsy in coagulopathy patients]  
Study Design  Other 
Public Title of Study   Clinical trial to study the Safety and Efficacy of Endoscopic Ultrasound guided Liver Biopsy in patients with derranged coagulation profile 
Scientific Title of Study   A Prospective Interventional Pilot study evaluating the Safety and Efficacy of Endoscopic Ultrasound guided Liver Biopsy in coagulopathy patients 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Praveer Rai 
Designation  Professor, Department of Gastroenterology,SGPGIMS, Lucknow 
Affiliation  SGPGIMS Lucknow 
Address  c/o Professor Praveer Rai c-block Gastromedicine SGPGIMS Lucknow

Lucknow
UTTAR PRADESH
226014
India 
Phone  8004904781  
Fax    
Email  praveer_rai@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Praveer Rai 
Designation  Professor, Department of Gastroenterology,SGPGIMS, Lucknow 
Affiliation  SGPGIMS Lucknow 
Address  c/o Professor Praveer Rai c-block Gastromedicine SGPGIMS Lucknow

Lucknow
UTTAR PRADESH
226014
India 
Phone  8004904781  
Fax    
Email  praveer_rai@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Mayank 
Designation  Senior Resident, Department of Gastroenterology,SGPGIMS, Lucknow 
Affiliation  SGPGIMS 
Address  C-block Gastromedicine SGPGIMS Lucknow

Lucknow
UTTAR PRADESH
226014
India 
Phone  9411178787  
Fax    
Email  mayanksgpgi@gmail.com  
 
Source of Monetary or Material Support  
SGPGIMS Lucknow 
 
Primary Sponsor  
Name  Dr Praveer Rai 
Address  Type IV/85, SGPGIMS Campus, Lucknow Uttar Pradesh 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Praveer Rai  SGPGIMS Lucknow  Ward A and Ward B Department of Gastroenterology SGPGIMS, Lucknow
Lucknow
UTTAR PRADESH 		 9530157095

praveer_rai@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee, SGPGIMS, Lucknow  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K77||Liver disorders in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Endoscopic Ultrasound guided Liver Biopsy   EUS will be done in the left lateral position after sedation with midazolam using a linear echoendoscope (GF-UCT180, Olympus Asia Pacific, Tokyo, Japan). Left lobe of liver will be targeted after positioning the echoendoscope just below gastroesophageal junction The needle used for biopsy will be a 19-gauge, fine needle biopsy needle (AcquireTM, Boston Scientific, Marlborough, MA, United States, Fig 1.), which has a Franseen tip, a three-point cutting design, which provides stability at puncture, maximises tissue capture and minimises fragmentation, which may result in improved diagnostic yield. After proper positioning of the EUS scope, colour Doppler will be used to avoid intervening blood vessels, and then on advancing the needle out of the echoendoscope channel, the stylet will be retracted a few millimetres to expose the needle tip and then the fork-tip needle will be advanced beyond the liver capsule and the stylet advanced to a locked position to express any gastric wall contaminant. One pass with 7-8 to and fro fanning movements of the needle will be done, with slow pull technique to increase the tissue yield. 
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  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 
 
ExclusionCriteria 
Details  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 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Primary Outcomes;
● Specimen quality for histological diagnosis in coagulopathy patient
● Specimen quality for histological diagnosis: Defined as histological diagnosis could
be made based on the amount of tissue obtained in needle.
● Portal Tract number: number of Complete Portal Tracts (CPTs)
● Specimen length: Total Sample Length (TSL) and Longest sample Length (LSL) 		 1 year 
 
Secondary Outcome  
Outcome  TimePoints 
Adverse events;
1.Bleeding-not requiring blood transfusion
2.Pain
Pain will be recorded using visual analogue scale(VAS)
Severe adverse effects:
1. Requiring Prolonged Hospitalisation
2. Requiring Intervention to stop Bleeding
3. Requiring blood transfusion
4. Death 		 1 year 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/07/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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 “fanning” 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
 
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