Clinical trial NCT06469489: Safety and Adequacy of Trans-jugular Liver Biopsy in Patients With Liver Disease: SAFE-TJLB Study
Official title: Safety and Adequacy of Trans-jugular Liver Biopsy in Patients With Liver Disease: SAFE-TJLB Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Liver Cirrhosis
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2024-06-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Liver Diseases of all etiologies

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients with liver biopsy taken of more than 1.5 cm in length
timeFrame: Day 0
measure: Adverse event
timeFrame: Day 7
Secondary outcomes:
measure: Procedural time (in and out of catheter)
timeFrame: Day 0
measure: Number of passes
timeFrame: Day 0
measure: Failure rate
timeFrame: Day 0
measure: Day care time
timeFrame: Day 1
measure: VAS: pain (Abdomen and Neck, pre and post procedure)
timeFrame: Day 0
measure: Number of patients with Complications- arrythmia, hematoma
timeFrame: Day 0
measure: Time of Fluro exposure
timeFrame: Day 0
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver & Biliary Sciences
state: Delhi
Study officials:
References: