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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06469489
Other study ID # ILBS-SAFE-TJLB
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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