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CTRI Number  CTRI/2023/06/053505 [Registered on: 02/06/2023] Trial Registered Prospectively
Last Modified On: 03/08/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Diagnostic 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Study the difference in the biopsy quality between right and left lobe of liver using endoscopic ultrasound 
Scientific Title of Study   RIGHT LOBE VERSUS LEFT LOBE LIVER BIOPSY UNDER ENDOSCOPIC ULTRASOUND GUIDANCE: A PROSPECTIVE COMPARATIVE STUDY  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jayanta Samanta 
Designation  Associate Professor  
Affiliation  Post Graduate Institute of Medical Education and Research, Chandigarh 
Address  Department of Gastroenterology, PGIMER, Chandigarh
PGIMER, Sector -12
Chandigarh
CHANDIGARH
160012
India 
Phone  9855319529  
Fax    
Email  dj_samanta@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Jayanta Samanta 
Designation  Associate Professor  
Affiliation  Post Graduate Institute of Medical Education and Research, Chandigarh 
Address  Department of Gastroenterology, PGIMER, Chandigarh
PGIMER, Sector -12
Chandigarh
CHANDIGARH
160012
India 
Phone  9855319529  
Fax    
Email  dj_samanta@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Jayanta Samanta 
Designation  Associate Professor  
Affiliation  Post Graduate Institute of Medical Education and Research, Chandigarh 
Address  Department of Gastroenterology, PGIMER, Chandigarh
PGIMER, Sector -12
Chandigarh
CHANDIGARH
160012
India 
Phone  9855319529  
Fax    
Email  dj_samanta@yahoo.co.in  
 
Source of Monetary or Material Support  
Department of Gastroenterology, Post Graduate Institute of Medical Education and Research, Chandigarh Sector-12 Chandigarh - 160012 
 
Primary Sponsor  
Name  Jayanta Samanta 
Address  Department of Gastroenterology, Post graduate Institute of Medical Education and Research, Chandigarh Sector - 12 
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 
Jayanta Samanta  Postgraduate Institute of Medical Education and Research, Chandigarh  Department of Gastroenterology Nehru Hospital, PGIMER, Chandigarh Sector -12 Chandigarh - 160012
Chandigarh
CHANDIGARH 		 9855319529

dj_samanta@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, PGIMER, Chandigarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K746||Other and unspecified cirrhosis ofliver,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Left Lobe liver biopsy  EUS-LB protocol using wet suction technique as mentioned below: i. Patients undergoing EUS-LB will receive moderate sedation using midazolam or nalbuphine or deep sedation using Propofol under anaesthetist monitoring, depending on the operator’s preference. ii. A linear array echoendoscope (Olympus GF-UCT180, Center Valley, USA) will be used. iii. Prior to the procedure, Doppler imaging will be used to ensure that no vascular structures are present along the expected trajectory of the needle iv. The EUS-LB will be performed using a 19-G FNB needle. v. The left lobe will be described as that liver parenchyma which is a few centimeters below the gastro-esophageal junction with the scope torqued clockwise. vi. A preferably long vessel free trajectory allowing free passage of the needle to a depth of at least 3 cm or more will be selected. vii. Prior to biopsy, the stylet will be removed and the needle will be primed with heparin flush and the suction syringe will be reattached to the needle hub. viii. The needle will be then introduced into the echoendoscope channel ix. Once liver parenchymal penetration is achieved with the needle (around 1 – 2 cm), full suction will be applied with the 20 mL vacuum syringe with fluid column. x. One pass will consist of a total of 3-4 to-and-fro needle motions using the fanning technique under direct and continuous EUS guided visualization of the tip of the needle. Preferably 1 pass will be taken from each lobe. xi. After the biopsy and before the needle is removed from the liver parenchyma, the suction will be turned off. xii. The specimen will be pushed from the needle directly into the formalin solution using the stylet flush. xiii. Time required for the procedure will be documented.  
Intervention  Right lobe liver biopsy  EUS-LB of right lobe using wet suction technique as mentioned below: i. Patients undergoing EUS-LB will receive moderate sedation using midazolam or nalbuphine or deep sedation using Propofol under anaesthetist monitoring, depending on the operator’s preference. ii. A linear array echoendoscope (Olympus GF-UCT180, Center Valley, USA) will be used to pass the scope into duodenum. iii. Prior to the procedure, Doppler imaging will be used to ensure that no vascular structures are present along the expected trajectory of the needle iv. The EUS-LB will be performed using a 19-G FNB needle. v. The right lobe will be accessed from the duodenal bulb. vi. A preferably long vessel free trajectory allowing free passage of the needle to a depth of at least 3 cm or more will be selected. vii. Prior to biopsy, the stylet will be removed and the needle will be primed with heparin flush and the suction syringe will be reattached to the needle hub. viii. The needle will be then introduced into the echoendoscope channel ix. Once liver parenchymal penetration is achieved with the needle (around 1 – 2 cm), full suction will be applied with the 20 mL vacuum syringe with fluid column. x. One pass will consist of a total of 3-4 to-and-fro needle motions using the fanning technique under direct and continuous EUS guided visualization of the tip of the needle. Preferably 1 pass will be taken from each lobe. xi. After the biopsy and before the needle is removed from the liver parenchyma, the suction will be turned off. xii. The specimen will be pushed from the needle directly into the formalin solution using the stylet flush. xiii. Time required for the procedure will be documented.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Patients requiring liver biopsy
2. Informed consent obtained from the patient
3. Patients >18 years old 
 
ExclusionCriteria 
Details  1. Unable to obtain informed consent from the patient
2. Medically unfit for sedation
3. Pregnant patient
4. Presence of a mass lesion in the liver requiring biopsy visualized on cross-sectional imaging
5. Irreversible coagulopathy as determined by platelet count < 50,000 mm3 or International Normalized Ratio (INR) > 1.5
6. Unable to stop anticoagulation or anti-platelet therapy for 5 days prior to the procedure
7. Hemophilia
8. Presence of an alternative etiology for elevated liver tests seen during liver biopsy, e.g. biliary obstruction during EUS examination
9. Suspected or proven malignant liver disease.
10. severe cardiovascular and pulmonary diseases 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Number of complete portal tracts (CPT)  At procedure. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Post processing maximum (or aggregate) specimen length
2. Length of the longest specimen
3. Adequacy of tissue sample
4. Rates of specimen adequacy (whether pathological diagnosis is reached or not)

 		 At procedure 
5. Assessment of pain scores (subjective & objective)
6. Pain medication requirement: use of narcotics/analgesics in both arms, post-procedure
 		 Immediate post procedure, 1 hr., 12 hr., 24 Hr.  
7. Rate of adverse events  Immediate post procedure, 24 hr, 1 week  
 
Target Sample Size   Total Sample Size="28"
Sample Size from India="28" 
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   Phase 3 
Date of First Enrollment (India)   15/06/2023 
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="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Not yet completed  
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Liver biopsy is the gold standard method for accurate assessment in the diagnosis and staging of liver diseases. A substantial number of liver diseases with diagnostic dilemmas after non-invasive tests are conclusively diagnosed by histopathology.  EUS guided liver biopsy (EUS-LB) is currently emerging as a cost effective, safe and well tolerated procedure and helps in more representative sampling. Various advancements have since been made in the technique of EUS-LB to maximize specimen quality. Studies have been published based on needle size, needle type, suction technique and number of needle actuation. Till date limited study exists as to whether one should perform left lobe or a right lobe liver biopsy. EUS-LB can be performed from either transgastric or a transduodenal station and multiple studies published till date have reported results from left lobe biopsy. Hence this study was planned comparing right versus left lobe EUS-guided liver biopsy in terms of adequacy of tissue sample and adverse event profile. It will also allow us to establish whether bilobar liver biopsy has any added advantage over either lobe (right/left) liver biopsy.

 
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