comparison of techniques of liver biopsy: endoscopic versus percutaneous method

Not Applicable

Completed

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

• Registration Number: CTRI/2020/09/027989
• Lead Sponsor: Jayanta Samanta

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 0

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

1.Age <12 years old

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 < 50,000 mm3 or International Normalized Ratio (INR) > 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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