Skip to content

Clinical trial to study the Safety and Efficacy of Endoscopic Ultrasound guided Liver Biopsy in patients with derranged coagulation profile

A Prospective Interventional Pilot study evaluating the Safety and Efficacy of Endoscopic Ultrasound guided Liver Biopsy in coagulopathy patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/07/043930
Enrollment
30
Registered
2022-07-12
Start date
Unknown
Completion date
Unknown
Last updated
2022-08-02

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: Endoscopic Ultrasound guided Liver Biopsy: EUS will be done in the left lateral position after sedation with midazolam using a linear echoendoscope (GF-UCT180, Olympus Asia Pacific, Tok

Sponsors

Dr Praveer Rai
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Adult Patients (Age >18 years) where liver biopsy is indicated 2.Those having coagulopathy or thrombocytopenia Coagulopathy is defined as INR >1.5 Thrombocytopenia is defined as Platelet count less than 1 lac/mm3

Exclusion criteria

Exclusion criteria: 1.Age 2.Pregnancy (confirmed with Standard of Care urine pregnancy test for all women with child-bearing potential only) 3.Inability to obtain Consent 4.Patient with INR >2.5 5.Patient with Platelet count below 30000/mm3 6. Patients with known malignancy precluding liver biopsy 7.Patient with Sepsis 8.Patient diagnosed with Acute liver Failure 9.Patient with diagnosis of Obstructive Jaundice 10.Patient on Anticoagulation

Design outcomes

Primary

MeasureTime frame
Primary Outcomes; â?? Specimen quality for histological diagnosis in coagulopathy patient â?? Specimen quality for histological diagnosis: Defined as histological diagnosis could be made based on the amount of tissue obtained in needle. â?? Portal Tract number: number of Complete Portal Tracts (CPTs) â?? Specimen length: Total Sample Length (TSL) and Longest sample Length (LSL)Timepoint: 1 year

Secondary

MeasureTime frame
Adverse events; 1.Bleeding-not requiring blood transfusion 2.Pain Pain will be recorded using visual analogue scale(VAS) Severe adverse effects: 1. Requiring Prolonged Hospitalisation 2. Requiring Intervention to stop Bleeding 3. Requiring blood transfusion 4. DeathTimepoint: 1 year

Countries

India

Contacts

Public ContactDr Mayank

SGPGIMS Lucknow

praveer_rai@yahoo.com8004904781

Outcome results

None listed

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