| CTRI Number |
CTRI/2025/01/079717 [Registered on: 29/01/2025] Trial Registered Prospectively |
| Last Modified On: |
27/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
19G FNB VS 19G FNA-EUS GUIDED LIVER BIOPSY |
|
Scientific Title of Study
|
19G FNB Vs 19G FNA-EUS guided liver biopsy- A non-inferiority randomized controlled trial |
| Trial Acronym |
ISITA TRIAL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashish Agarwal |
| Designation |
Associate Professor |
| Affiliation |
Department of Gastroenterology, AIIMS Jodhpur |
| Address |
Room no 115
1st floor, OPD block,
AIIMS Hospital, Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9971981716 |
| Fax |
|
| Email |
drashu123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vvienodd Uppuv |
| Designation |
Senior Resident |
| Affiliation |
Department of Gastroenterology, AIIMS Jodhpur |
| Address |
Room no 115
1st floor, Block A
OPD block
AIIMS Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
7989190768 |
| Fax |
|
| Email |
vinoduppu3@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vvienodd Uppuv |
| Designation |
Senior Resident |
| Affiliation |
Department of Gastroenterology, AIIMS Jodhpur |
| Address |
Room no 115
1st floor,Block A,
OPD block
AIIMS Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
7989190768 |
| Fax |
|
| Email |
vinoduppu3@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS, Jodhpur
Rajasthan,
India 342005 |
|
|
Primary Sponsor
|
| Name |
Not applicable |
| Address |
Not applicable
|
| Type of Sponsor |
Other [] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ashish agarwal |
AIIMS JODHPUR |
Room no 115
1st floor OPD block
Aiims jodhpur
Jodhpur
RAJASTHAN |
7989190768
drashu123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee, AIIMS JODHPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K739||Chronic hepatitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
19 G EUS FNA |
Patients will follow all standard preoperative instructions prior to anaesthesia.
Upon undergoing general anaesthesia with propofol,patient in the left lateral position, Endoscope was introduced and near cardia of stomach and left lobe of liver was localised. Doppler study will be done to look for significant doppler signals in the path of needle. 19 G FNA needle was introduced into the liver parenchyma using wet suction technique, and 1 pass and 3 actuations, Liver biopsy is taken. Macroscopic onsite evaluation will be done to confirm the sample adequacy.The approximate total duration of procedure is 10 minutes |
| Comparator Agent |
19 G EUS FNB NEEDLE |
Patients will follow all standard preoperative instructions prior to anaesthesia. Upon undergoing general anaesthesia with propofol, patient in the left lateral position, Endoscope was introduced and near cardia of stomach and left lobe of liver was localised. Doppler study will be done to look for significant doppler signals in the path of needle. 19 G FNB needle was introduced into the liver parenchyma using wet suction technique, and 1 pass and 3 actuations, Liver biopsy is taken. Macroscopic onsite evaluation will be done to confirm the sample adequacy.The total duration of procedure is 10 minutes. |
| Intervention |
PATIENT AND OUTCOME ASSESSOR BLINDED RANDOMISED CONTROL TRAIL |
study the adequacy of sample, fragments and complete portal tracts and histological diagnosis of the sample obtained by 19G FNA and 19G FNB needles in EUS guided liver biopsy |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with an indication for liver biopsy
2.Platelet count more than 50,000
3.International normalized ratio (INR) less than 1.5
|
|
| ExclusionCriteria |
| Details |
1.Age lessthan 18 years
2.Pregnant patients
3.Inability to obtain consent
4.Anticoagulants or anti-platelet agents use (excluding aspirin) within the last 7 to 10 days
5.Platelet count less than 50,000
6.INR morethan 1.5
7.Presence of ascites
8.Hemophilia |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Comparison of adequacy of liver biopsy specimen between 19 G EUS FNA and 19 G FNB needles with Pre processing length of longest piece more than 15 mm and CPTs more than or equal to 5 in number
2.Comparison of Diagnostic yield of liver biopsy between 19 G EUS FNA and 19 G FNB needles |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Length of Longest Piece
2.Number of Participants with LLP post-processing length less than 2 cm or more than 2 cm
3.Pre-processing Aggregate Specimen Length measured in centimeter
4.Post-processing Aggregate Specimen Length measured in centimeter
5.Number of portal triads in the specimen.
6.Number of Participants with less than 11 Portal Triads or more than 11 Portal Triads |
23 months from January 2024 to November 2025 |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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)
|
10/02/2025 |
| 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="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Chronic liver disease can be due to various causes and usually diagnosed based on identification of risk factors and various blood tests. Identification of etiology becomes important as modification of risk factors and treatment of underlying cause of CLD can results in prevention of further liver damage and also reversal of underlying fibrosis or cirrhosis. There are various methods of liver biopsy with each modality has its merits and demerits. Previous studies have demonstrated that percutaneous, trans jugular and EUS guided liver biopsy were comparable in sample adequacy, but however, EUS liver biopsy was associated with lesser adverse events.In EUS guided liver biopsy previous studies have demonstrate that FNB needle gives larger samples than FNB but however, the histological diagnosis was comparable in both the groups. But, FNB needle costs around INR 40000 with one unit kit pricing around INR 63000 while FNA needle costs around 20000 with one EUS kit costing around 36000 making it more cost effective . In view of limited data comparing EUS LB using 19 G FNA versus 19 G FNB needles, we have planned this non inferiority randomized controlled trial comparing FNA vs FNB with 19 G needle taking primary objective as pre processing total sample length of atleast 15 mm and portal tracts of atleast 5 in number and histological diagnosis taking previously done studies as references. |