NAFLDNCT04235855
EUS Guided Liver Biopsy - Will it Give Better Yield, More Tissue With Less Complication?
A study testing Endoscopic USG guided Liver biopsy and Percutaneous Liver Biopsy in people with NAFLD and Alcoholic Hepatitis, run by Asian Institute of Gastroenterology, India at 1 site in India.
Trial summary
Liver biopsy would be done by Endoscopic Ultrasound using Acquire needle. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- NAFLD, Alcoholic Hepatitis
- What is being tested?
- Endoscopic USG guided Liver biopsy and Percutaneous Liver Biopsy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIndia
- Study dates
- 31 Oct 2019to 1 Jan 2022
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of any undiagnosed hepatic disease (after extensive investigation - serological as well as imaging) requiring a liver biopsy
- Patients of NAFLD who need liver biopsy
- Alcoholic hepatitis patients needing biopsy
- Any patient with unexplained transaminesemia > 1.5 times ULN needing a liver biopsy as advised by Hepatologist
Who cannot join
- Any liver Space occupying lesion suspicious of malignancy
- Platelet count <80,000
- INR > 1.5
- Pregnancy
- Severe cardiovascular and pulmonary diseases
- Recent use of anti-platelet agents within 5 days of the procedure
- Unwilling to provide informed consent
Trial locations and contacts
1 site in 1 country.
India1 site
Asian Institute of Gastroenterology Hospitals
Hyderabad, Telangana, 500089
About this study
Official title: EUS Guided Liver Biopsy Proposal Titled : EUS Guided Liver Biopsy - Will it Give Better Yield , More Tissue With Less Complication ?
Liver biopsy would be done by Endoscopic Ultrasound using Acquire needle.
Read the detailed description
In this study, we aim to evaluate the tissue adequacy of EUS guided liver biopsy for parenchymal liver disease and to evaluate if diagnostic yield of left lobe is non-inferior to right lobe biopsies and to assess if combination biopsies have better yield than single lobe biopsies. Safety of the procedure and technical success would be noted.
The data would be analysed using SPSS software and needful variables and tests would be used as per statistical requirement.
- Conditions
- NAFLD, Alcoholic Hepatitis
- Being tested
- Endoscopic USG guided Liver biopsy, Percutaneous Liver Biopsy
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Hepatitis, Alcoholic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic USG guided Liver biopsyDevice
Diagnostic yield with EUS guided liver biopsy - Left lobe Bx vs combined right and left lobe or vs right lobe would be assessed.
Percutaneous Liver BiopsyDevice
All liver biopsies done in the Institute as routine procedure by percutaneous route would be compared with the EUS guided biopsy in respect to safety , tissue quality and diagnostic yield .
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic USG guided Liver biopsy | Experimental | Olympus linear echo endoscope (GF -UCT 180, Olympus Ltde, Tkyo, Japan) will be used. 19 Gz EUS Acquire needle Boston ©Scientific Corp will be used for liver tissue acquisition. Receives: Device: Endoscopic USG guided Liver biopsy |
| Percutaneous Liver biopsy | Active comparator | All liver biopsies done in the Institute as routine procedure by percutaneous route would be compared with the EUS guided biopsy in respect to safety , tissue quality and diagnostic yield . Receives: Device: Percutaneous Liver Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic yield with EUS guided liver biopsy .
The diagnostic yield of a right lobe biopsy and left lobe biopsy would be compared to see if right lobe biopsy gives any additional information for diagnosis when compared to left lobe .
Measured: 3 days
Secondary outcomes (7)
Safety of procedure
Sedation related adverse effect will be monitored as per the institute protocol . Any type of bleed during procedure or needing additional intervention would be recorded as a major adverse effect .
Measured: 3 days
Duration of procedure
Time between start and end of the procedure would be noted .
Measured: 30 minutes
Size of tissue acquired
The length of the biopsy tissue would be ascertained immediately by onsite pathologist and would be assessed as per the AASLD and Royal College of Pathology definition .
Measured: 3 days
Number of portal tracts
The adequacy of the sample would be assessed as per the AASLD and Royal College of Pathology definition (CPTs 11) .
Measured: 3 days
Post procedural complications
Any procedure related complications such as pain (>6 on VAS) and bleeding would be noted .
Measured: 3 days
NAS score in fatty liver patients
Difference in NAS score between right lobe and right vs left lobe in fatty liver patients
Measured: 3 days
Patient recovery time
Patient recovery time when compared to per cutaneous liver biopsy procedure .
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2020
- Study start31 Oct 2019
- Primary completion1 Jan 2022
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for NAFLDStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- All liver biopsies done in the Institute as routine procedure by percutaneous route would be compared with the EUS guided biopsy in respect to safety , tissue quality and diagnostic yield.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Mithun Sharma, Asian Institute of Gastroenterology, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04235855
- Sponsor's protocol ID
- ECR/346/Inst/AP/2013/RR-19
- Status last verified
- Jan 2022
- First submitted
- 16 Jan 2020
- Last updated
- 4 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gor N, Salem SB, Jakate S, Patel R, Shah N, Patil A. Histological adequacy of EUS-guided liver biopsy when using a 19-gauge non-Tru-Cut FNA needle. Gastrointest Endosc. 2014 Jan;79(1):170-2. doi: 10.1016/j.gie.2013.06.031. Epub 2013 Jul 31. No abstract available.
PubMed 23916397Dewitt J, McGreevy K, Cummings O, Sherman S, Leblanc JK, McHenry L, Al-Haddad M, Chalasani N. Initial experience with EUS-guided Tru-cut biopsy of benign liver disease. Gastrointest Endosc. 2009 Mar;69(3 Pt 1):535-42. doi: 10.1016/j.gie.2008.09.056.
PubMed 19231495Schulman AR, Thompson CC, Odze R, Chan WW, Ryou M. Optimizing EUS-guided liver biopsy sampling: comprehensive assessment of needle types and tissue acquisition techniques. Gastrointest Endosc. 2017 Feb;85(2):419-426. doi: 10.1016/j.gie.2016.07.065. Epub 2016 Aug 13.
PubMed 27530070
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EUS Guided Liver Biopsy Proposal Titled : EUS Guided Liver Biopsy - Will it Give Better Yield , More Tissue With Less Complication ?
- ClinicalTrials.gov ID
- NCT04235855
- Acronym / sponsor ID
- ECR/346/Inst/AP/2013/RR-19
- Conditions
- NAFLD, Alcoholic Hepatitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- 31 Oct 2019 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 22 Jan 2020 (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 would be done by Endoscopic Ultrasound using Acquire needle.
Detailed description
In this study, we aim to evaluate the tissue adequacy of EUS guided liver biopsy for parenchymal liver disease and to evaluate if diagnostic yield of left lobe is non-inferior to right lobe biopsies and to assess if combination biopsies have better yield than single lobe biopsies. Safety of the procedure and technical success would be noted.
The data would be analysed using SPSS software and needful variables and tests would be used as per statistical requirement.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- All liver biopsies done in the Institute as routine procedure by percutaneous route would be compared with the EUS guided biopsy in respect to safety , tissue quality and diagnostic yield.
| Arm | Type | Receives |
|---|---|---|
| Endoscopic USG guided Liver biopsy | Experimental | Device: Endoscopic USG guided Liver biopsyOlympus linear echo endoscope (GF -UCT 180, Olympus Ltde, Tkyo, Japan) will be used. 19 Gz EUS Acquire needle Boston ©Scientific Corp will be used for liver tissue acquisition. |
| Percutaneous Liver biopsy | Active comparator | Device: Percutaneous Liver BiopsyAll liver biopsies done in the Institute as routine procedure by percutaneous route would be compared with the EUS guided biopsy in respect to safety , tissue quality and diagnostic yield . |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients of any undiagnosed hepatic disease (after extensive investigation - serological as well as imaging) requiring a liver biopsy
- Patients of NAFLD who need liver biopsy
- Alcoholic hepatitis patients needing biopsy
- Any patient with unexplained transaminesemia > 1.5 times ULN needing a liver biopsy as advised by Hepatologist
Key exclusion criteria (7 listed)
- Any liver Space occupying lesion suspicious of malignancy
- Platelet count <80,000
- INR > 1.5
- Pregnancy
- Severe cardiovascular and pulmonary diseases
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 |
|---|---|---|
| Endoscopic USG guided Liver biopsyDiagnostic yield with EUS guided liver biopsy - Left lobe Bx vs combined right and left lobe or vs right lobe would be assessed. | Device | Endoscopic USG guided Liver biopsy |
| Percutaneous Liver BiopsyAll liver biopsies done in the Institute as routine procedure by percutaneous route would be compared with the EUS guided biopsy in respect to safety , tissue quality and diagnostic yield . | Device | Percutaneous Liver biopsy |
Primary outcome
Diagnostic yield with EUS guided liver biopsy .
Time frame: 3 days
The diagnostic yield of a right lobe biopsy and left lobe biopsy would be compared to see if right lobe biopsy gives any additional information for diagnosis when compared to left lobe .
7 secondary outcomes
Safety of procedure
Time frame: 3 days
Duration of procedure
Time frame: 30 minutes
Size of tissue acquired
Time frame: 3 days
Number of portal tracts
Time frame: 3 days
Post procedural complications
Time frame: 3 days
NAS score in fatty liver patients
Time frame: 3 days
Patient recovery time
Time frame: 3 days
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 4 Jan 2022.
- Background: PubMed 23916397Gor N, Salem SB, Jakate S, Patel R, Shah N, Patil A. Histological adequacy of EUS-guided liver biopsy when using a 19-gauge non-Tru-Cut FNA needle. Gastrointest Endosc. 2014 Jan;79(1):170-2. doi: 10.1016/j.gie.2013.06.031. Epub 2013 Jul 31. No abstract available.
- Background: PubMed 19231495Dewitt J, McGreevy K, Cummings O, Sherman S, Leblanc JK, McHenry L, Al-Haddad M, Chalasani N. Initial experience with EUS-guided Tru-cut biopsy of benign liver disease. Gastrointest Endosc. 2009 Mar;69(3 Pt 1):535-42. doi: 10.1016/j.gie.2008.09.056.
- Background: PubMed 27530070Schulman AR, Thompson CC, Odze R, Chan WW, Ryou M. Optimizing EUS-guided liver biopsy sampling: comprehensive assessment of needle types and tissue acquisition techniques. Gastrointest Endosc. 2017 Feb;85(2):419-426. doi: 10.1016/j.gie.2016.07.065. Epub 2016 Aug 13.
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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 Endoscopic USG guided Liver biopsy and Percutaneous Liver Biopsy in people with NAFLD and Alcoholic Hepatitis, run by Asian Institute of Gastroenterology, 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 4 inclusion and 7 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 4 Jan 2022. 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?
Diagnostic yield with EUS guided liver biopsy . (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04235855, which also lists 3 linked publications.
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 4 Jan 2022.