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

NCT06469489 | Unknown

• 1 other identifier: ILBS-SAFE-TJLB
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Liver Cirrhosis

Outcome Measures

Primary Outcomes (2)

• Number of patients with liver biopsy taken of more than 1.5 cm in length

  Day 0

• Adverse event

  Day 7

Secondary Outcomes (7)

• Procedural time (in and out of catheter)

  Day 0

• Number of passes

  Day 0

• Failure rate

  Day 0

• Day care time

  Day 1

• VAS: pain (Abdomen and Neck, pre and post procedure)

  Day 0

Study Arms (1)

Liver Disease patients undergoing Trans-Jugular Liver Biopsy

Other: Liver Disease of all etiologies

Interventions

Liver Disease of all etiologies OTHER

No intervention

Liver Disease patients undergoing Trans-Jugular Liver Biopsy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Liver Diseases of all etiologies

You may qualify if:

• years age.
• Patient with suspected or known liver disease undergoing trans-jugular liver biopsy as per clinical indication.

You may not qualify if:

• \- None

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Dr Satender Pal Singh, DM

CONTACT

01146300000; ama.satender@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2024
• First Posted: June 21, 2024
• Study Start: June 21, 2024
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: July 8, 2024

Record last verified: 2024-01

Locations

IN (1)