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

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.

Study Overview

• Status: Recruiting
• Conditions: Liver Cirrhosis
• Intervention / Treatment: Other: Liver Disease of all etiologies

Detailed 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).

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Dr Satender Pal Singh, DM; Phone Number: 01146300000; Email: ama.satender@gmail.com

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110070
      • Recruiting
      • Institute of Liver & Biliary Sciences
      • Contact: Dr Satender Pal Singh, MD; Phone Number: 01146300000; Email: ama.satender@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Liver Diseases of all etiologies

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Liver Disease patients undergoing Trans-Jugular Liver Biopsy	Other: Liver Disease of all etiologies; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of patients with liver biopsy taken of more than 1.5 cm in length	Day 0
Adverse event	Day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural time (in and out of catheter)		Day 0
Number of passes		Day 0
Failure rate		Day 0
VAS: pain (Abdomen and Neck, pre and post procedure)	VAS=10 is maximum pain	Day 0
Number of patients with Complications- arrythmia, hematoma		Day 0
Time of Fluro exposure		Day 0
Day care time		Day 1

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2024
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: January 3, 2024
• First Submitted That Met QC Criteria: June 17, 2024
• First Posted (Actual): June 21, 2024

Study Record Updates

• Last Update Posted (Actual): July 8, 2024
• Last Update Submitted That Met QC Criteria: July 4, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Fibrosis; Liver Diseases; Liver Cirrhosis
• Other Study ID Numbers: ILBS-SAFE-TJLB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No