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CTRI Number  CTRI/2023/06/053953 [Registered on: 16/06/2023] Trial Registered Prospectively
Last Modified On: 03/08/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Diagnostic 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To compare the adequacy of the tissue obtained using different suction techniques during endoscopic ultrasound guided biopsy of lymph nodes  
Scientific Title of Study   COMPARISON OF TISSUE QUALITY USING VARIOUS SUCTION TECHNIQUES IN ENDOSCOPIC ULTRASOUND-GUIDED FINE NEEDLE BIOPSY OF LYMPH NODES: A RANDOMISED 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, Room No. - 20, Level I, Block F Nehru Hospital, PGIMER, Chandigarh Sector - 12

Chandigarh
CHANDIGARH
160012
India 
Phone  09855319529  
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, Room No. - 20, Level I, Block F Nehru Hospital, PGIMER, Chandigarh Sector - 12

Chandigarh
CHANDIGARH
160012
India 
Phone  09855319529  
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, Room No. - 20, Level I, Block F Nehru Hospital, PGIMER, Chandigarh Sector - 12

Chandigarh
CHANDIGARH
160012
India 
Phone  09855319529  
Fax    
Email  dj_samanta@yahoo.co.in  
 
Source of Monetary or Material Support  
Department of Gastroenterology, PGIMER, Chandigarh Sector - 12 Chandigarh - 160012.  
 
Primary Sponsor  
Name  Jayanta Samanta 
Address  Department of Gastroenterology, PGIMER, Chandigarh Sector - 12 Chandigarh - 160012 
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  Post Graduate Institute of Medical Education and Research, Chandigarh, India  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: K928||Other specified diseases of the digestive system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Slow-pull technique  EUS guided puncture of the lymph node will be done. After that, during tissue acquisition, the stylet will be slowly retracted with fanning technique of the needle in the lesion. 10-20 to-and-fro movements will be made with minimal negative pressure provided by slow pull of stylet which will be retracted slowly till about 1 meter over 40 to 60 second. 
Intervention  Wet suction technique with 10-ml suction  In this method, once the stylet is removed, the needle will be flushed with 5 mL of saline replacing the air column. A 10-mL suction syringe with 2 ml of saline in it will be loaded to maximum suction, and then it will be attached in a locked position to the needle. The lesion will be punctured will the needle and sample will be acquired using the suction syringe. 
Intervention  Wet suction technique with 5-ml suction  In this method, once the stylet is removed, the needle will be flushed with 5 mL of saline replacing the air column. A 5-mL suction syringe with 2 ml of saline in it will be loaded to maximum suction, and then it will be attached in a locked position to the needle. The lesion will be punctured with the needle and sample will be acquired using the suction syringe. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. age >18 years
2. lymph nodes visualized on EUS and amenable for biopsy
3. Informed consent to participate in the study
 
 
ExclusionCriteria 
Details  1. Age <18 years,
2. Lymph nodes inaccessible or not visualised with EUS
3. Lymph nodes <10 mm
4. international normalized ratio (INR) >1.5
5. platelet count of <50,000 cells/cubic millimetre
6. unstable clinical conditions or any contraindication for EUS
7. Inability to give informed consent
8. Pregnancy
9. Lesions returned to be not lymph nodes will be dropped out
 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The primary endpoint will be the rate of histological adequacy in patients with lymph nodes who underwent EUS-FNB using 22-G FNB needles with the conventional stylet slow-pull or the wet aspiration with varying suction pressure.   At baseline - during tissue acquisition 
 
Secondary Outcome  
Outcome  TimePoints 
Specimen adequacy  At baseline - during tissue acquisition 
Blood contamination of specimens  At baseline - during tissue acquisition 
Comparison of the two techniques in terms of sensitivity, specificity, negative likelihood ratio, positive likelihood ratio & accuracy.   At baseline - during tissue acquisition 
 
Target Sample Size   Total Sample Size="145"
Sample Size from India="145" 
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)   26/06/2023 
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 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) is a high-yielding and safe diagnostic modality for tissue diagnosis.  Both lymph nodes and solid organs (pancreatic and extra-pancreatic) in the vicinity of the GI tract can be sampled with EUS-FNA.  The key relevant outcomes for assessing any sampling technique include specimen adequacy, diagnostic yield, accuracy, and adverse events. In order to maximize the quality and adequacy of the specimens using EUS-FNA, various techniques have been evaluated namely the use of different sampling techniques, number of needle passes, different needle sizes and designs, and lately, using a cytopathologist for a rapid on-site evaluation. Majority of the studies have investigated the performance of sampling techniques in solid lesions. But lymph nodes and solid lesions are entirely different in terms of their structural histology and “tissue behavior”. No study exists on the different suction techniques for only lymph nodes using the new generation of biopsy needles. Hence, this study was planned to evaluate the effect of the two techniques of stylet slow-pull and wet suction with varying suction pressure on the sample quality while carrying out EUS-FNB of lymph nodes.  
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