Skip to content

19G FNB VS 19G FNA-EUS GUIDED LIVER BIOPSY

19G FNB Vs 19G FNA-EUS guided liver biopsy- A non-inferiority randomized controlled trial - ISITA TRIAL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/01/079717
Enrollment
54
Registered
2025-01-29
Start date
Unknown
Completion date
Unknown
Last updated
2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K739- Chronic hepatitis, unspecified

Interventions

Intervention1: 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 1

Sponsors

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients with an indication for liver biopsy 2.Platelet count more than 50,000 3.International normalized ratio (INR) less than 1.5

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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 needlesTimepoint: Baseline

Secondary

MeasureTime frame
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 TriadsTimepoint: 23 months from January 2024 to November 2025

Countries

India

Contacts

Public ContactVvienodd Uppuv

Department of Gastroenterology, AIIMS Jodhpur

vinoduppu3@gmail.com7989190768

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026