Evaluating the safety and effectiveness of trans-jugular liver biopsy for liver disease
Safety and Adequacy of Trans-jugular Liver Biopsy in Patients With Liver Disease: SAFE-TJLB Study
This study is trying to see if a new way of taking liver samples called trans-jugular liver biopsy is safe and effective for people with liver disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Institute of Liver and Biliary Sciences, India Academic / other |
| Locations | 1 site (New Delhi, Delhi) |
| Trial ID | NCT06469489 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the safety and adequacy of trans-jugular liver biopsy (TJLB) in patients with liver disease. The study will involve patients aged 18-65 who are undergoing TJLB for clinical indications, collecting data on procedural outcomes such as sample adequacy, safety, and complications. The research will be conducted at the Institute of Liver and Biliary Sciences in New Delhi from November 2023 to May 2024, focusing on various demographic and clinical parameters. The findings will help determine the effectiveness of TJLB compared to traditional biopsy methods.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-65 with suspected or known liver disease requiring a liver biopsy.
Not a fit: Patients outside the age range of 18-65 or those without liver disease will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more effective method for obtaining liver tissue samples in patients with liver disease.
How similar studies have performed: Previous studies have indicated that trans-jugular liver biopsy can be a safe alternative for patients with contraindications to percutaneous biopsy, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New Delhi, Delhi
- Institute of Liver & Biliary Sciences — New Delhi, Delhi, India (Recruiting)
Study contacts
- Study coordinator: Dr Satender Pal Singh, DM
- Email: ama.satender@gmail.com
- Phone: 01146300000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.