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

Liver Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06469489
• Other study ID #: ILBS-SAFE-TJLB
• Status: Not yet recruiting
• Start date: June 25, 2024
• Est. completion date: June 30, 2024

Study information

• Verified date: January 2024
• Source: Institute of Liver and Biliary Sciences, India
• Contact: Dr Satender Pal Singh, DM
• Phone: 01146300000
• Email: ama.satender[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Hypothesis:

Trans-jugular liver biopsy is safe, gives adequate sample for pathological examination in patients with liver disease.

Aim of study:

To evaluate safety and adequacy of trans-jugular liver biopsy in patient with liver disease.

Primary objective:

1. Adequacy of trans-jugular liver biopsy

2. Safety of trans-jugular liver biopsy

Secondary objective:

1. Indications of liver biopsy

2. Procedural time (in and out of catheter)

3. Number of passes

4. Failure rate

5. Day care time

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

7. Complications- arrythmia, hematoma

8. Time of Fluro exposure

Patients and methods Study Design A prospective, observational cohort study will be conducted in patients with suspected or known liver disease between November 2023 to May 2024 at the Institute of Liver and Biliary Sciences (ILBS), New Delhi.

Clinical protocol An informed consent was taken from patients with liver disease undergoing liver biopsy as per clinical indication. The following demographic data was recorded at inclusion: Age, gender, co-morbidities, type, and etiology of liver disease. Laboratory parameters include complete blood count, liver function tests, kidney function tests, INR. Severity of liver disease (MELD score, CTP score, AARC score).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. 18-65 years age.

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

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Liver Cirrhosis
• Liver Diseases

Intervention

Other:
• Liver Disease of all etiologies
No intervention

Locations

Country	Name	City	State
India	Institute of Liver & Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with liver biopsy taken of more than 1.5 cm in length		Day 0
Primary	Adverse event		Day 0
Secondary	Procedural time (in and out of catheter)		Day 0
Secondary	Number of passes		Day 0
Secondary	Failure rate		Day 0
Secondary	Day care time		Day 0
Secondary	VAS: pain (Abdomen and Neck, pre and post procedure)	VAS=10 is maximum pain	Day 0
Secondary	Number of patients with Complications- arrythmia, hematoma		Day 0
Secondary	Time of Fluro exposure		Day 0