use of EUS-guided liver biopsy (procedure) in Parenchymal Liver Disease.

EUS-guided Versus Percutaneous Ultrasound-guided Biopsy for Parenchymal Liver Disease: A Randomized Controlled, Non-inferiority Trial - NIL

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/10/058529

Enrollment

Registered

2023-10-11

Start date

Unknown

Completion date

Unknown

Last updated

2023-11-13

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

Conditions

Health Condition 1: K769- Liver disease, unspecified

Interventions

Intervention1: EUS guided liver biopsy: EUS guided liver biopsy will be done by 19G Franseen needle Duration:Duration: 10-30 minutes Frequency: Once Control Intervention1: Percutaneous Liver Biopsy:

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients > 18 years of age. 2. Eligibility for deep sedation with propofol. 3. Undergoing liver biopsy for diagnosis/evaluation/staging.

Exclusion criteria

Exclusion criteria: 1. Coagulopathy, defined by platelet count 1.7. 2. Inability to discontinue anticoagulation or antiplatelet agents for 5 days prior to the procedure. 3. Presence of unrelieved biliary obstruction. 4. Presence of ascites. 5. Suspected or known hepatic malignancy. 6. Hypertensive patients with uncontrolled blood pressure. (SBP >150 and/or DBP >100mmHg) 7. Medically unfit for sedation. 8. Inability to provide informed consent. 9. Cannot understand Hindi or English should be excluded since they will not be able to reply objectively to questionnaire.

Design outcomes

Primary

Measure	Time frame
Specimen adequacy defined by total specimen length (TSL) = 15 mm and = 8 complete portal triads (CPTs)Timepoint: Day 0	—

Secondary

Measure	Time frame
Adverse events after the procedureTimepoint: 72 hours;Post-procedure pain measured on VAS from 0-10Timepoint: 4 hours;Pre-fix aggregate specimen length.Timepoint: 3 days;Pre-fix longest intact specimen length.Timepoint: 3 days;Proportion of specimens >20mm in aggregate length.Timepoint: 3 days;Proportion of specimens with >11 CPTs.Timepoint: 3 days;Proportion of specimens with a conclusive etiological diagnosisTimepoint: 3 days;Proportion of specimens with a conclusive pathological diagnosisTimepoint: 3 days;Total number of biopsy fragments.Timepoint: 3 days;Total Number of fragments >9mm.Timepoint: 3 days;Total specimen complete portal tracts (CPTs).Timepoint: 3 days	—

Measure

Time frame

Adverse events after the procedureTimepoint: 72 hours;Post-procedure pain measured on VAS from 0-10Timepoint: 4 hours;Pre-fix aggregate specimen length.Timepoint: 3 days;Pre-fix longest intact specimen length.Timepoint: 3 days;Proportion of specimens >20mm in aggregate length.Timepoint: 3 days;Proportion of specimens with >11 CPTs.Timepoint: 3 days;Proportion of specimens with a conclusive etiological diagnosisTimepoint: 3 days;Proportion of specimens with a conclusive pathological diagnosisTimepoint: 3 days;Total number of biopsy fragments.Timepoint: 3 days;Total Number of fragments >9mm.Timepoint: 3 days;Total specimen complete portal tracts (CPTs).Timepoint: 3 days

—

Countries

India

Contacts

Public ContactDr Vikram Bhatia

Institute of Liver and Biliary Sciences

vikrambhatiadr@gmail.com01146300000

Outcome results

None listed

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