Liver DiseasesPEREUSNCT05295537
Percutaneous Versus Endoscopic Ultrasound-guided Liver Biopsy (PEREUS)
A study testing PERCUTANEOUS LIVER BIOPSY (PLB) and ENDOSCOPIC ULTRASOUND GUIDED LIVER BIOPSY (EUS-LB) in people with Liver Diseases, run by Hospital Clinico Universitario de Santiago at 1 site in Spain.
Trial summary
Although the use of liver biopsy (LB) has decreased with the emerging non-invasive markers and techniques to evaluate liver fibrosis, histopathologic examination of liver tissue is necessary to confirm the type of liver injury. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Diseases
- What is being tested?
- PERCUTANEOUS LIVER BIOPSY (PLB) and ENDOSCOPIC ULTRASOUND GUIDED LIVER BIOPSY (EUS-LB)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteSpain
- Study dates
- 19 Jan 2022to 1 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 18 years, any gender
- Understanding and informed consent signed
- Fit for deep sedation
Who cannot join
- Age below 18 years
- Not signed informed consent
- Contraindication for a deep sedation
- Pregnancy
- Focal liver lesion that requires biopsy visualized by other imaging techniques
- Coagulopathy (INR>1.5 or platelets < 50,000)
- Inability to withdraw anticoagulant or antithrombotic agents
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Clinico Universitario de Santiago
Santiago de Compostela, A Coruña, 15706
About this study
Official title: Prospective, Randomized, Comparative, Non-inferiority, Multicentre Trial of Quality of Samples Obtained by Percutaneous Liver Biopsy Versus Endoscopic Ultrasound-guided Liver Biopsy
Although the use of liver biopsy (LB) has decreased with the emerging non-invasive markers and techniques to evaluate liver fibrosis, histopathologic examination of liver tissue is necessary to confirm the type of liver injury. The aim of our study is to compare two methods for obtaining histological material from the liver: the percutaneous liver biopsy (PLB) and the Endoscopic ultrasound (EUS) guided liver biopsy (EUS-LB)
Read the detailed description
LB remains the gold standard diagnostic test for most of the focal and parenchymal liver diseases. LB has an important diagnostic role in selected parenchymal liver diseases such as autoimmune hepatitis and infiltrative liver disorders, and in some cases, it helps clinicians to elucidate between overlapping diagnoses Traditionally, percutaneous (PLB) or transjugular approaches have been used to acquire liver samples. In recent tears EUS has emerged as an alternative and safe method to obtain liver samples, by puncturing the liver from the gastric or duodenal wall. In fact, EUS-guided LB has been shown equal or superior compared to PLB and transjugular approaches in retrospective series. EUS - LB has shown to produce excellent histological performance based on liver society guidelines requirements for parameters used in assessing histological yield which include the number of complete portal triads (CPT), sample size and total specimen length (TSL) with a low rate of adverse events EUS - LB has several advantages over the traditional liver biopsy methods: it provides simultaneous access to both liver lobes, enables real-time visualization avoiding the puncture of a large vessel and then reducing the rate of complications, it allows to perform a simultaneously endoscopic and endosonography evaluation of the pancreatobiliary system and it could decrease the level of the anxiety of patients (by the use of deep sedation) and then perhaps increasing the satisfaction with the procedure Despite the fact of the high diagnostic yield of EUS-LB in obtaining adequate samples from the liver and the low rate of adverse events reported with this method, there is an almost complete lack of randomized trials comparing EUS - LB with the traditional percutaneous route.
The aim of our study is to compare the quality of samples obtained and the diagnostic efficacy of EUS - LB against PLB in all patients that have an indication for a liver biopsy
- Conditions
- Liver Diseases
- Being tested
- PERCUTANEOUS LIVER BIOPSY (PLB), ENDOSCOPIC ULTRASOUND GUIDED LIVER BIOPSY (EUS-LB)
- Keywords
- Biopsy, Histology, Endoscopic ultrasound, Diagnosis
- Medical subject headings
- Liver Diseases, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PERCUTANEOUS LIVER BIOPSY (PLB)Procedure or surgery
Percutaneous liver biopsy using a 16 gauge (G) Trucut needle.
ENDOSCOPIC ULTRASOUND GUIDED LIVER BIOPSY (EUS-LB)Procedure or surgery
EUS-guided liver biopsy using a 19 gauge (G) Franseen core EUS needle
| Study group | Role | What they receive |
|---|---|---|
| PERCUTANEOUS LIVER BIOPSY (PLB) | Active comparator | Patients randomized to percutaneous liver biopsy. Receives: Procedure: PERCUTANEOUS LIVER BIOPSY (PLB) |
| ENDOSCOPIC ULTRASOUND GUIDED LIVER BIOPSY (EUS - LB) | Experimental | Patients randomized to EUS-guided liver biopsy Receives: Procedure: ENDOSCOPIC ULTRASOUND GUIDED LIVER BIOPSY (EUS-LB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of tissue samples obtained by EUS-guided liver biopsy compared to percutaneous liver biopsy.
The quality of samples is based in the combination of a specimen length >20 mms and more than 10 complete portal triads (both conditions are required).
Measured: Up to 2 weeks
Secondary outcomes (3)
Diagnostic accuracy of EUS-guided liver biopsy compared to percutaneous liver biopsy.
Percentage of samples allowing an adequate histological diagnosis.
Measured: Up to 2 weeks
Adverse events associated with EUS-guided liver biopsy compared to percutaneous liver biopsy.
Adverse events evaluated according to the American Society of Gastrointestinal Endoscopy (ASGE) lexicon.
Measured: At 1 hour, 4 hours, 24 hours, 7 days, and 30 days
Patient satisfaction after EUS-guided liver biopsy compared to percutaneous liver biopsy.
Satisfaction survey that includes five points; four are questions scored from 1: bad to 5: excellent; and one is a dichotomic question (Yes/No). Survey will be performed 24 hours after the procedure by phone call.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2022
- Study start19 Jan 2022
- Primary completion1 Sep 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseasesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, parallel assignment.
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinico Universitario de Santiago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, J. Enrique Domínguez-Muñoz, Hospital Clinico Universitario de Santiago
- Investigators
- J. Enrique Dominguez-Muñoz, MD, PhD, Study director, Hospital Clínico Universitario de Santiago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05295537
- Sponsor's protocol ID
- USE-01-2021
- Acronym
- PEREUS
- Status last verified
- Feb 2023
- First submitted
- 16 Jan 2022
- Last updated
- 1 Mar 2023
- 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 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Comparative, Non-inferiority, Multicentre Trial of Quality of Samples Obtained by Percutaneous Liver Biopsy Versus Endoscopic Ultrasound-guided Liver Biopsy
- ClinicalTrials.gov ID
- NCT05295537
- Acronym / sponsor ID
- PEREUS / USE-01-2021
- Conditions
- Liver Diseases
- Keywords
- Biopsy, Histology, Endoscopic ultrasound, Diagnosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Hospital Clinico Universitario de SantiagoUniversity, hospital or other
- Study start
- 19 Jan 2022 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 25 Mar 2022 (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.
Although the use of liver biopsy (LB) has decreased with the emerging non-invasive markers and techniques to evaluate liver fibrosis, histopathologic examination of liver tissue is necessary to confirm the type of liver injury. The aim of our study is to compare two methods for obtaining histological material from the liver: the percutaneous liver biopsy (PLB) and the Endoscopic ultrasound (EUS) guided liver biopsy (EUS-LB)
Detailed description
LB remains the gold standard diagnostic test for most of the focal and parenchymal liver diseases. LB has an important diagnostic role in selected parenchymal liver diseases such as autoimmune hepatitis and infiltrative liver disorders, and in some cases, it helps clinicians to elucidate between overlapping diagnoses Traditionally, percutaneous (PLB) or transjugular approaches have been used to acquire liver samples. In recent tears EUS has emerged as an alternative and safe method to obtain liver samples, by puncturing the liver from the gastric or duodenal wall. In fact, EUS-guided LB has been shown equal or superior compared to PLB and transjugular approaches in retrospective series. EUS - LB has shown to produce excellent histological performance based on liver society guidelines requirements for parameters used in assessing histological yield which include the number of complete portal triads (CPT), sample size and total specimen length (TSL) with a low rate of adverse events EUS - LB has several advantages over the traditional liver biopsy methods: it provides simultaneous access to both liver lobes, enables real-time visualization avoiding the puncture of a large vessel and then reducing the rate of complications, it allows to perform a simultaneously endoscopic and endosonography evaluation of the pancreatobiliary system and it could decrease the level of the anxiety of patients (by the use of deep sedation) and then perhaps increasing the satisfaction with the procedure Despite the fact of the high diagnostic yield of EUS-LB in obtaining adequate samples from the liver and the low rate of adverse events reported with this method, there is an almost complete lack of randomized trials comparing EUS - LB with the traditional percutaneous route.
The aim of our study is to compare the quality of samples obtained and the diagnostic efficacy of EUS - LB against PLB in all patients that have an indication for a liver biopsy
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, parallel assignment.
| Arm | Type | Receives |
|---|---|---|
| PERCUTANEOUS LIVER BIOPSY (PLB) | Active comparator | Procedure: PERCUTANEOUS LIVER BIOPSY (PLB)Patients randomized to percutaneous liver biopsy. |
| ENDOSCOPIC ULTRASOUND GUIDED LIVER BIOPSY (EUS - LB) | Experimental | Procedure: ENDOSCOPIC ULTRASOUND GUIDED LIVER BIOPSY (EUS-LB)Patients randomized to EUS-guided 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)
- Age over 18 years, any gender
- Understanding and informed consent signed
- Fit for deep sedation
Key exclusion criteria (7 listed)
- Age below 18 years
- Not signed informed consent
- Contraindication for a deep sedation
- Pregnancy
- Focal liver lesion that requires biopsy visualized by other imaging techniques
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 |
|---|---|---|
| PERCUTANEOUS LIVER BIOPSY (PLB)Percutaneous liver biopsy using a 16 gauge (G) Trucut needle. | Procedure or surgery | PERCUTANEOUS LIVER BIOPSY (PLB) |
| ENDOSCOPIC ULTRASOUND GUIDED LIVER BIOPSY (EUS-LB)EUS-guided liver biopsy using a 19 gauge (G) Franseen core EUS needle | Procedure or surgery | ENDOSCOPIC ULTRASOUND GUIDED LIVER BIOPSY (EUS - LB) |
Primary outcome
Quality of tissue samples obtained by EUS-guided liver biopsy compared to percutaneous liver biopsy.
Time frame: Up to 2 weeks
The quality of samples is based in the combination of a specimen length >20 mms and more than 10 complete portal triads (both conditions are required).
3 secondary outcomes
Diagnostic accuracy of EUS-guided liver biopsy compared to percutaneous liver biopsy.
Time frame: Up to 2 weeks
Adverse events associated with EUS-guided liver biopsy compared to percutaneous liver biopsy.
Time frame: At 1 hour, 4 hours, 24 hours, 7 days, and 30 days
Patient satisfaction after EUS-guided liver biopsy compared to percutaneous liver biopsy.
Time frame: 24 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 1 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for Liver Diseases
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Not yet recruitingObservational study
Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant
Hematopoietic Stem Cell Transplant
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
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.
J. Enrique Dominguez-Muñoz, MD, PhD study director
Hospital Clínico Universitario de Santiago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PERCUTANEOUS LIVER BIOPSY (PLB) and ENDOSCOPIC ULTRASOUND GUIDED LIVER BIOPSY (EUS-LB) in people with Liver Diseases, run by Hospital Clinico Universitario de Santiago at 1 site in Spain.
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 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 1 Mar 2023. 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 Spain. 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?
Quality of tissue samples obtained by EUS-guided liver biopsy compared to percutaneous liver biopsy. (time frame: Up to 2 weeks). 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 1 Mar 2023.