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comparison of techniques of liver biopsy: endoscopic versus percutaneous method

Comparative study of the efficacy and safety of EUS guided liver biopsy versus percutaneous liver biopsy: A multi-center randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/09/027989
Enrollment
48
Registered
2020-09-23
Start date
Unknown
Completion date
Unknown
Last updated
2023-08-21

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

Conditions

Health Condition 1: K77- Liver disorders in diseases classified elsewhere

Interventions

Intervention1: EUS-Guided liver biopsy: It will be done as per the Institution’s EUS-LB protocol using wet suction technique. Patients undergoing EUS-LB will receive moderate sedation using midazolam

Sponsors

Jayanta Samanta
Lead Sponsor
Radhika Chavan
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1. All patients referred for liver biopsy for any indication. 2. Informed consent obtained from the patient/parent 3. = 12 years old 4. Ability to undergo conscious sedation for EUS procedure

Exclusion criteria

Exclusion criteria: 1. Age 2. Unable to obtain informed consent from the patient/parent 3. Medically unfit for sedation 4. Pregnant patients 5. Presence of a mass lesion in the liver requiring biopsy visualized on cross-sectional imaging 6. Irreversible coagulopathy as determined by platelet count 1.5 7. Unable to stop anticoagulation or anti-platelet therapy for 5 days prior to the procedure 8. Hemophilia 9. Presence of an alternative etiology for elevated liver tests seen during the liver biopsy, e.g. biliary obstruction during EUS examination 10. Suspected or proven malignant liver disease. 11. severe cardiovascular and pulmonary diseases

Design outcomes

Primary

MeasureTime frame
To compare EUS-liver biopsy and percutaneous liver biopsy for the ability to acquire adequate tissue sampleTimepoint: At the end of the biopsy procedure

Secondary

MeasureTime frame
1. Rates of specimen adequacy 2. Post processing maximum specimen length 3. Portal tracts: The total number of complete portal tracts obtained. 4. The total length of time for the procedure will be documented in minutes. 5. Rate of adverse events 6. Assessment of pain scores 7. Pain medication requirement: use of narcotics/analgesics in both the arms, post procedure. Timepoint: At the end of the biopsy procedure

Countries

India

Contacts

Public ContactJayanta Samanta

Post Graduate Institute of Medical Education and Research, Chandigarh

dj_samanta@yahoo.co.in9855319529

Outcome results

None listed

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