Liver CirrhosisNCT06469489
Safety and Adequacy of Trans-jugular Liver Biopsy in Patients With Liver Disease: SAFE-TJLB Study
An observational study of Liver Cirrhosis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- Liver Disease of all etiologies
- How many people
- 703 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jan 2020to 31 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Liver Diseases of all etiologies
Who may be able to join
- 18-65 years age.
- Patient with suspected or known liver disease undergoing trans-jugular liver biopsy as per clinical indication.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
India1 site
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
About this 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.
Read the 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:
- Adequacy of trans-jugular liver biopsy
- Safety of trans-jugular liver biopsy
Secondary objective:
- Indications of liver biopsy
- Procedural time (in and out of catheter)
- Number of passes
- Failure rate
- Day care time
- VAS: pain (Abdomen and Neck, pre and post procedure)
- Complications- arrythmia, hematoma
- 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). The study comprises two components: a retrospective component covering the period from January 2020 to May 2024, and a prospective component from June 2024 to May 2025.
- Conditions
- Liver Cirrhosis
- Being tested
- Liver Disease of all etiologies
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver Disease of all etiologiesOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Liver Disease patients undergoing Trans-Jugular Liver Biopsy | Not described Receives: Other: Liver Disease of all etiologies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with liver biopsy taken of more than 1.5 cm in length
Measured: Day 0
Adverse event
Measured: Day 7
Secondary outcomes (7)
Procedural time (in and out of catheter)
Measured: Day 0
Number of passes
Measured: Day 0
Failure rate
Measured: Day 0
Day care time
Measured: Day 1
VAS: pain (Abdomen and Neck, pre and post procedure)
VAS=10 is maximum pain
Measured: Day 0
Number of patients with Complications- arrythmia, hematoma
Measured: Day 0
Time of Fluro exposure
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start1 Jan 2020
- Primary completion31 May 2025
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 703 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06469489
- Sponsor's protocol ID
- ILBS-SAFE-TJLB
- Status last verified
- Sep 2026
- First submitted
- 3 Jan 2024
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Adequacy of Trans-jugular Liver Biopsy in Patients With Liver Disease: SAFE-TJLB Study
- ClinicalTrials.gov ID
- NCT06469489
- Acronym / sponsor ID
- ILBS-SAFE-TJLB
- Conditions
- Liver Cirrhosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 703 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 21 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Adequacy of trans-jugular liver biopsy
- Safety of trans-jugular liver biopsy
Secondary objective:
- Indications of liver biopsy
- Procedural time (in and out of catheter)
- Number of passes
- Failure rate
- Day care time
- VAS: pain (Abdomen and Neck, pre and post procedure)
- Complications- arrythmia, hematoma
- 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). The study comprises two components: a retrospective component covering the period from January 2020 to May 2024, and a prospective component from June 2024 to May 2025.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liver Disease patients undergoing Trans-Jugular Liver Biopsy | – | Other: Liver Disease of all etiologies |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Liver Diseases of all etiologies
Key inclusion criteria (2 listed)
- 18-65 years age.
- Patient with suspected or known liver disease undergoing trans-jugular liver biopsy as per clinical indication.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liver Disease of all etiologiesNo intervention | Other | Liver Disease patients undergoing Trans-Jugular Liver Biopsy |
Primary outcome
Number of patients with liver biopsy taken of more than 1.5 cm in length
Time frame: Day 0
Adverse event
Time frame: Day 7
7 secondary outcomes
Procedural time (in and out of catheter)
Time frame: Day 0
Number of passes
Time frame: Day 0
Failure rate
Time frame: Day 0
Day care time
Time frame: Day 1
VAS: pain (Abdomen and Neck, pre and post procedure)
Time frame: Day 0
Number of patients with Complications- arrythmia, hematoma
Time frame: Day 0
Time of Fluro exposure
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cirrhosis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with liver biopsy taken of more than 1.5 cm in length (time frame: Day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.