Safety and Adequacy of Trans-jugular Liver Biopsy in Patients With Liver Disease: SAFE-TJLB Study
NCT06469489 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 60
Last updated 2024-07-08
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.
Conditions
Interventions
- OTHER
-
Liver Disease of all etiologies
No intervention
Sponsors & Collaborators
-
Institute of Liver and Biliary Sciences, India
lead OTHER
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-06-21
- Primary Completion
- 2024-09-30
- Completion
- 2024-09-30
Countries
- India
Study Locations
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