Liver Cirrhosis Clinical Trial
Official title:
EUS-guided Versus Percutaneous Ultrasound-guided Biopsy for Parenchymal Liver Disease: A Randomized Controlled, Non-inferiority Trial
Liver biopsy may be indicated in various clinical scenarios to help diagnose and manage liver diseases. Endoscopic ultrasound (EUS) liver biopsy and percutaneous USG guided liver biopsy are two methods used to obtain liver tissue samples. EUS involves using an endoscope with an ultrasound probe to guide a needle through the stomach wall and into the liver, while percutaneous ultrasound guided biopsy involves inserting a needle directly through the skin and into the liver using ultrasound guidance. A specimen measuring 15 mm or more and containing 6 to 8 CPTs is generally considered adequate for the histologic diagnosis of diffuse liver disease. However, stricter requirements of specimen length of 20 mm or longer with 11 or more CPTs for reliable grading and staging of chronic viral hepatitis have been recommended. With this study we aim to study in a head-to-head comparison between EUS-guided and percutaneous (PC) liver biopsies, with regards to tissue acquisition adequacy.
Status | Not yet recruiting |
Enrollment | 90 |
Est. completion date | August 31, 2024 |
Est. primary completion date | August 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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: 1. Coagulopathy, defined by platelet count < 70,000/mL and/or INR > 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. |
Country | Name | City | State |
---|---|---|---|
India | Institiute of liver and biliary sciences | New Delhi |
Lead Sponsor | Collaborator |
---|---|
Institute of Liver and Biliary Sciences, India |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Specimen adequacy defined by total specimen length (TSL) = 15 mm and = 8 complete portal triads (CPTs) | Day 0 | ||
Secondary | Post-procedure pain measured on Visual Analogue Scale from (Minimum: 0, Max:10) | 4 hours | ||
Secondary | Pre-fix longest intact specimen length. | 3 days | ||
Secondary | Pre-fix aggregate specimen length. | 3 days | ||
Secondary | Total specimen complete portal tracts (CPTs). | 3 days | ||
Secondary | Proportion of specimens >20mm in aggregate length. | 3 days | ||
Secondary | Proportion of specimens with >11 CPTs. | 3 days | ||
Secondary | Total number of fragments. | Day 0 | ||
Secondary | Total Number of fragments >9mm. | 3 days | ||
Secondary | Proportion of specimens with a conclusive etiological diagnosis | 3 days | ||
Secondary | Proportion of specimens with a conclusive pathological diagnosis | 3 days | ||
Secondary | Adverse events after the procedure | 72 hours |
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