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NCT06469489

Safety and Adequacy of Trans-jugular Liver Biopsy in Patients With Liver Disease: SAFE-TJLB Study

Sponsor: Institute of Liver and Biliary Sciences, India

View on ClinicalTrials.gov

Summary

Liver biopsy is considered the gold standard for the evaluation of acute and chronic liver disorders. Liver biopsy provides information regarding diagnosis, disease progression, and response to therapy in patients with chronic liver diseases. Trans-jugular liver biopsy (TJLB) consists of obtaining liver tissue through a rigid cannula introduced into one of the hepatic veins typically using jugular venous access. This approach reduces the risk of hemorrhage after biopsy because the bleeding resulting from the biopsy needle will drain into the hepatic veins. In the past, the specimens obtained by a transjugular approach were considered suboptimal compared with the samples obtained with percutaneous needles because they were smaller and more fragmented. TJLB was initially indicated for patients who had a contraindication to percutaneous biopsy such as those with a coagulopathy or congenital clotting disorders, ascites, acute liver failure, large amount of adipose tissue, and patients after liver transplantation. The clinical role of TJLB has expanded due to the possibility of performing hemodynamic evaluation of the hepatic and portal venous systems, which provides useful information and may guide therapy in patients with portal hypertension. Lacuna in literature: There is no prospective study in India evaluating the safety and efficacy of trans-jugular liver biopsy in patients with liver disease.

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

OBSERVATIONAL

Enrollment

703

Start Date

2020-01-01

Completion Date

2025-05-31

Last Updated

2026-09-24

Healthy Volunteers

No

Conditions

Interventions

OTHER

Liver Disease of all etiologies

No intervention

Locations (1)

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, India