Liver CirrhosisNCT06047327
EUS-guided Versus Percutaneous Ultrasound-guided Biopsy for Parenchymal Liver Disease
A study testing EUS guided liver biopsy and Percutaneous Liver Biopsy in people with Liver Cirrhosis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
Liver biopsy may be indicated in various clinical scenarios to help diagnose and manage liver diseases. Endoscopic ultrasound (EUS) liver biopsy and percutaneous USG guided liver biopsy are two methods used to obtain liver tissue samples. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- EUS guided liver biopsy and Percutaneous Liver Biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteIndia
- Study dates
- 1 Nov 2023to 30 Nov 2025
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients > 18 years of age.
- Eligibility for deep sedation with propofol.
- Undergoing liver biopsy for diagnosis/evaluation/staging.
Who cannot join
- Coagulopathy, defined by platelet count < 70,000/mL and/or INR > 1.7.
- Inability to discontinue anticoagulation or antiplatelet agents for 5 days prior to the procedure.
- Presence of unrelieved biliary obstruction.
- Presence of ascites.
- Suspected or known hepatic malignancy.
- Hypertensive patients with uncontrolled blood pressure. (SBP >150 and/or DBP>100mmHg)
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- Medically unfit for sedation.
- Inability to provide informed consent.
- Cannot understand Hindi or English should be excluded since they will not be able to reply objectively to questionnaire.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EUS-guided Versus Percutaneous Ultrasound-guided Biopsy for Parenchymal Liver Disease: A Randomized Controlled, Non-inferiority Trial
Liver biopsy may be indicated in various clinical scenarios to help diagnose and manage liver diseases. Endoscopic ultrasound (EUS) liver biopsy and percutaneous USG guided liver biopsy are two methods used to obtain liver tissue samples. EUS involves using an endoscope with an ultrasound probe to guide a needle through the stomach wall and into the liver, while percutaneous ultrasound guided biopsy involves inserting a needle directly through the skin and into the liver using ultrasound guidance.
A specimen measuring 15 mm or more and containing 6 to 8 CPTs is generally considered adequate for the histologic diagnosis of diffuse liver disease. However, stricter requirements of specimen length of 20 mm or longer with 11 or more CPTs for reliable grading and staging of chronic viral hepatitis have been recommended. With this study we aim to study in a head-to-head comparison between EUS-guided and percutaneous (PC) liver biopsies, with regards to tissue acquisition adequacy.
Read the detailed description
Aim and Objective - EUS-LB with a 19G Franseen needle is non-inferior to PC-LB with a 18G BioPince Needle, with regards to total specimen length and diagnostic adequacy.
Hypothesis - i. EUS-LB with a 19G FNB needle is non-inferior to PC-LB with a 18G full core biopsy needle, with regards to total specimen length and diagnostic adequacy.
ii. There would be lesser procedure related pain and higher patient satisfaction with EUS-LB compared to PC-LB.
Study population:
- Patients > 18 years of age.
- Eligibility for deep sedation with propofol.
- Undergoing liver biopsy for diagnosis/evaluation/staging.
Study design: All consecutive in-patients and out-patients requiring liver biopsy for evaluation of diffuse parenchymal liver disease will be evaluated for inclusion.
Study period: 1 year
- Sample size with justification: The percentage success rate of procurement of adequate liver biopsies (defined by specimen length ≥ 15 mm and ≥ 8 CPTs) was assumed to be 90% with PC-LB based on two recent retrospective studies comparing PC-LB with EUS-LB. These studies used the bigger 16G Biopince needles. (Literature: Bhogal N. Endosc Int Open 2020, 99%; Facciorusso A. Cancers 2021, 100%). With similar criteria for adequacy, the success rates with EUS-LB were assumed to be 85% for non-inferiority comparison, based on recent studies of EUS-LB using 19G Franseen needles. (Literature: Hashimoto R. Dig Dis Sci 2020, 100%; Aggarwal SN. GIE 2021, 97.2%; Nallapeta N. Hepatology 2021, 55.6%)
- With alpha-value of 10%, power of 80%, and non-inferiority margin of 10%, we need to enroll 44 patients in each of PC-LB and EUS-LB arms, for a total sample size of 88 patients. We plan to enroll 90 patients in this trial to account for technical inadequacies.
- Intervention: Patient after screening for all exclusion criteria will be randomized into either EUS guided liver biopsy or USG guided percutaneous biopsy
- Monitoring and assessment: All patients would undergo vital and baseline parameter screening before randomization. Based on randomization they will undergo the liver biopsy procedure. Post procedure all the patients will be closely observed in the recovery area for at least 4 hours after the procedure, VAS for pain will be noted \& 4-point patient satisfaction scale will be provided to them. They will be followed up after 72 hours by a phone call or in their rooms if updated to check for any adverse effects.
- Pain will be assessed with a visual analogue scale (VAS) score (minimum score = 0, maximum score = 10).
- Patient satisfaction will be evaluated by using a four-point scale ('Very satisfied', 'Satisfied', 'Less satisfied' and 'Not satisfied at all').
- Statistical Analysis: Descriptive data following a normal distribution will be reported as means (+ standard deviation [SD]), whereas nonparametric data will be reported as median (range). Comparisons between the two needles will be performed with a t test, Wilcoxon rank sum test, or chi-square test as appropriate.
- A Mantel-Haenszel test of trend will be performed to determine whether a linear association existed between EUS-LB sampling and VCTE and CAP results.
- Adverse effects:
AEs will be defined as any deviation from the anticipated intra-procedure and post-procedural course.
- Conditions
- Liver Cirrhosis
- Being tested
- EUS guided liver biopsy, Percutaneous Liver Biopsy
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS guided liver biopsyDiagnostic test
Procedure will be performed by 19G Franseen needle.
Percutaneous Liver BiopsyDiagnostic test
procedure will be done by 18G BioPince Needle
| Study group | Role | What they receive |
|---|---|---|
| EUS Guided Liver Biopsy | Experimental | Procedure will be done by 19G Franseen needle in EUS guided liver biopsy. Receives: Diagnostic Test: EUS guided liver biopsy |
| Percutaneous Liver Biopsy | Active comparator | Procedure will be done by 18G BioPince Needle in percutaneous liver biopsy. Receives: Diagnostic Test: Percutaneous Liver Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specimen adequacy defined by total specimen length (TSL) ≥ 15 mm and ≥ 8 complete portal triads (CPTs)
Measured: Day 0
Secondary outcomes (11)
Post-procedure pain measured on Visual Analogue Scale from (Minimum: 0, Max:10)
Measured: 4 hours
Pre-fix longest intact specimen length.
Measured: 3 days
Pre-fix aggregate specimen length.
Measured: 3 days
Total specimen complete portal tracts (CPTs).
Measured: 3 days
Proportion of specimens >20mm in aggregate length.
Measured: 3 days
Proportion of specimens with >11 CPTs.
Measured: 3 days
Total number of fragments.
Measured: Day 0
Total Number of fragments >9mm.
Measured: 3 days
Proportion of specimens with a conclusive etiological diagnosis
Measured: 3 days
Proportion of specimens with a conclusive pathological diagnosis
Measured: 3 days
Adverse events after the procedure
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start1 Nov 2023
- Primary completion30 Nov 2025
- Study completion30 Nov 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 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
- NCT06047327
- Sponsor's protocol ID
- ILBS-EUS-01
- Status last verified
- Dec 2025
- First submitted
- 14 Sep 2023
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EUS-guided Versus Percutaneous Ultrasound-guided Biopsy for Parenchymal Liver Disease: A Randomized Controlled, Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT06047327
- Acronym / sponsor ID
- ILBS-EUS-01
- Conditions
- Liver Cirrhosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 21 Sep 2023 (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 may be indicated in various clinical scenarios to help diagnose and manage liver diseases. Endoscopic ultrasound (EUS) liver biopsy and percutaneous USG guided liver biopsy are two methods used to obtain liver tissue samples. EUS involves using an endoscope with an ultrasound probe to guide a needle through the stomach wall and into the liver, while percutaneous ultrasound guided biopsy involves inserting a needle directly through the skin and into the liver using ultrasound guidance.
A specimen measuring 15 mm or more and containing 6 to 8 CPTs is generally considered adequate for the histologic diagnosis of diffuse liver disease. However, stricter requirements of specimen length of 20 mm or longer with 11 or more CPTs for reliable grading and staging of chronic viral hepatitis have been recommended. With this study we aim to study in a head-to-head comparison between EUS-guided and percutaneous (PC) liver biopsies, with regards to tissue acquisition adequacy.
Detailed description
Aim and Objective - EUS-LB with a 19G Franseen needle is non-inferior to PC-LB with a 18G BioPince Needle, with regards to total specimen length and diagnostic adequacy.
Hypothesis - i. EUS-LB with a 19G FNB needle is non-inferior to PC-LB with a 18G full core biopsy needle, with regards to total specimen length and diagnostic adequacy.
ii. There would be lesser procedure related pain and higher patient satisfaction with EUS-LB compared to PC-LB.
Study population:
- Patients > 18 years of age.
- Eligibility for deep sedation with propofol.
- Undergoing liver biopsy for diagnosis/evaluation/staging.
Study design: All consecutive in-patients and out-patients requiring liver biopsy for evaluation of diffuse parenchymal liver disease will be evaluated for inclusion.
Study period: 1 year
- Sample size with justification: The percentage success rate of procurement of adequate liver biopsies (defined by specimen length ≥ 15 mm and ≥ 8 CPTs) was assumed to be 90% with PC-LB based on two recent retrospective studies comparing PC-LB with EUS-LB. These studies used the bigger 16G Biopince needles. (Literature: Bhogal N. Endosc Int Open 2020, 99%; Facciorusso A. Cancers 2021, 100%). With similar criteria for adequacy, the success rates with EUS-LB were assumed to be 85% for non-inferiority comparison, based on recent studies of EUS-LB using 19G Franseen needles. (Literature: Hashimoto R. Dig Dis Sci 2020, 100%; Aggarwal SN. GIE 2021, 97.2%; Nallapeta N. Hepatology 2021, 55.6%)
- With alpha-value of 10%, power of 80%, and non-inferiority margin of 10%, we need to enroll 44 patients in each of PC-LB and EUS-LB arms, for a total sample size of 88 patients. We plan to enroll 90 patients in this trial to account for technical inadequacies.
- Intervention: Patient after screening for all exclusion criteria will be randomized into either EUS guided liver biopsy or USG guided percutaneous biopsy
- Monitoring and assessment: All patients would undergo vital and baseline parameter screening before randomization. Based on randomization they will undergo the liver biopsy procedure. Post procedure all the patients will be closely observed in the recovery area for at least 4 hours after the procedure, VAS for pain will be noted \& 4-point patient satisfaction scale will be provided to them. They will be followed up after 72 hours by a phone call or in their rooms if updated to check for any adverse effects.
- Pain will be assessed with a visual analogue scale (VAS) score (minimum score = 0, maximum score = 10).
- Patient satisfaction will be evaluated by using a four-point scale ('Very satisfied', 'Satisfied', 'Less satisfied' and 'Not satisfied at all').
- Statistical Analysis: Descriptive data following a normal distribution will be reported as means (+ standard deviation [SD]), whereas nonparametric data will be reported as median (range). Comparisons between the two needles will be performed with a t test, Wilcoxon rank sum test, or chi-square test as appropriate.
- A Mantel-Haenszel test of trend will be performed to determine whether a linear association existed between EUS-LB sampling and VCTE and CAP results.
- Adverse effects:
AEs will be defined as any deviation from the anticipated intra-procedure and post-procedural course.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EUS Guided Liver Biopsy | Experimental | Diagnostic Test: EUS guided liver biopsyProcedure will be done by 19G Franseen needle in EUS guided liver biopsy. |
| Percutaneous Liver Biopsy | Active comparator | Diagnostic Test: Percutaneous Liver BiopsyProcedure will be done by 18G BioPince Needle in percutaneous liver biopsy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients > 18 years of age.
- Eligibility for deep sedation with propofol.
- Undergoing liver biopsy for diagnosis/evaluation/staging.
Key exclusion criteria (9 listed)
- Coagulopathy, defined by platelet count < 70,000/mL and/or INR > 1.7.
- Inability to discontinue anticoagulation or antiplatelet agents for 5 days prior to the procedure.
- Presence of unrelieved biliary obstruction.
- Presence of ascites.
- Suspected or known hepatic malignancy.
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 |
|---|---|---|
| EUS guided liver biopsyProcedure will be performed by 19G Franseen needle. | Diagnostic test | EUS Guided Liver Biopsy |
| Percutaneous Liver Biopsyprocedure will be done by 18G BioPince Needle | Diagnostic test | Percutaneous Liver Biopsy |
Primary outcome
Specimen adequacy defined by total specimen length (TSL) ≥ 15 mm and ≥ 8 complete portal triads (CPTs)
Time frame: Day 0
11 secondary outcomes
Post-procedure pain measured on Visual Analogue Scale from (Minimum: 0, Max:10)
Time frame: 4 hours
Pre-fix longest intact specimen length.
Time frame: 3 days
Pre-fix aggregate specimen length.
Time frame: 3 days
Total specimen complete portal tracts (CPTs).
Time frame: 3 days
Proportion of specimens >20mm in aggregate length.
Time frame: 3 days
Proportion of specimens with >11 CPTs.
Time frame: 3 days
Total number of fragments.
Time frame: Day 0
Total Number of fragments >9mm.
Time frame: 3 days
Proportion of specimens with a conclusive etiological diagnosis
Time frame: 3 days
Proportion of specimens with a conclusive pathological diagnosis
Time frame: 3 days
Adverse events after the procedure
Time frame: 72 hours
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 5 Jan 2026.
- Individual participant dataSharing planned: No
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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?
A study testing EUS guided liver biopsy and Percutaneous Liver Biopsy in people with 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 3 inclusion and 9 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 5 Jan 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?
Specimen adequacy defined by total specimen length (TSL) ≥ 15 mm and ≥ 8 complete portal triads (CPTs) (time frame: Day 0). 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 5 Jan 2026.