Liver CirrhosisNCT04644055
EUS Share-wave in Patients With Liver Cirrhosis
An observational study of Liver Cirrhosis, run by Instituto Ecuatoriano de Enfermedades Digestivas at 1 site in Ecuador.
Trial summary
Patients with chronic liver disease may develop progressive hepatic fibrosis. Liver cirrhosis should be detected at the early stages in order to avoid the complications related to these two conditions. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- EUS- share wave of the liver
- How many people
- 59 participants
- Where
- 1 siteEcuador
- Study dates
- 1 Mar 2020to 15 Apr 2023
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Performed at Instituto Ecuatoriano de Enfermedades Digestivas (IECED), an academic tertiary center in Guayaquil, Ecuador. Patients will be invited to participate during outpatient clinic visits. All consecutive participants need to be ≥18 years old and has a history of chronic liver disease with histological proven liver cirrhosis. Control patients will be patients without history of chronic liver disease and will be included following a transient elastography test within normal limits.
Who may be able to join
- Provided informed written consent
- Age greater than 18 years of age
- Confirmed diagnosis of chronic liver disease based on transient elastography
- Patients with EUS-guided liver biopsy
Who cannot join
- History of uncontrolled coagulopathy
- Contraindications to EUS-guided liver biopsy
- Pregnancy or nursing
- History of hepatocellular carcinoma
- Patients with equivocal transient elastography results
Trial locations and contacts
1 site in 1 country.
Ecuador1 site
Ecuadorian Institute of Digestive Diseases
Guayaquil, Guayas, 090505
About this study
Official title: Endoscopic Ultrasound Share-wave for the Evaluation of Patients With Chronic Liver Disease
Patients with chronic liver disease may develop progressive hepatic fibrosis. Liver cirrhosis should be detected at the early stages in order to avoid the complications related to these two conditions.
The diagnostic work-up of patients with chronic liver disease includes less-invasive diagnostic methods such as abdominal ultrasonography, transient elastography, upper endoscopy; and more invasive procedures, mainly liver biopsy and portal pressure gradient measurement, both with associated risks.
Read more
Endoscopic ultrasound offers a benefit of including all diagnostic work-up in a single procedure. The investigators previously demonstrated that EUS-elastography of the liver and spleen is reliable marker for predicting liver cirrhosis.
Recently, a quantitative evaluation of fibrosis using share wave elastography was introduced, mainly for the pancreatic tumor fibrosis measurement (2). Elastography measures the elasticity of tissues (hardness); whereas share wave measures the tissue elasticity as the elastic modulus by measuring the share wave velocity. Share wave measurement will be performed with the Arietta 850 Endoscopic ultrasound console using a linear ultrasound video gastroscope EUS-J10 (Pentax Medical, Hoya Corp, Japan). The investigators proposed the EUS-share wave of the liver as a reliable diagnostic marker in patients with liver cirrhosis.
Read the detailed description
A non-blinded, prospective trial. Primary disease condition: liver cirrhosis Keywords: Liver Cirrhosis; Fibrosis; Endoscopic Ultrasonography; Elasticity Imaging, Tissue.
Study Design: Observational study model: a non-blinded, non-randomized, prospective trial Time perspective: prospective Enrollment type: actual Number of subjects: 16 participants Number of groups/cohorts: 2 cohorts Target follow-up duration: 6 months
Based on the proportion of patients with the liver strain histogram (LSH) >87.40 among cirrhosis (87.5%) and control cases (31.0%) described by Robles-Medranda et al. (1), the investigators calculated eight patients per study group with a 5% and 20% of alpha and beta error respectively, with an 80% of power statistic.
- Conditions
- Liver Cirrhosis
- Being tested
- EUS- share wave of the liver
- Keywords
- liver cirrhosis; fibrosis, endoscopic ultrasonography, elasticity imaging, tissue
- Medical subject headings
- Liver Cirrhosis, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS- share wave of the liverDiagnostic test
Evaluation of the right and left hepatic lobe with EUS-guided share wave
| Study group | Role | What they receive |
|---|---|---|
| Chronic liver disease with liver cirrhosis | Evaluation of the right and left hepatic lobe with EUS-guided share wave evaluation. All patients with chronic liver disease will have a transient elastography evaluation, EUS- elastography of the liver and an EUS-guided liver biopsy. Receives: Diagnostic Test: EUS- share wave of the liver | |
| Control patients | Patients without history of chronic liver disease after clinical and transient elastography evaluation will be submitted for EUS-guided share wave evaluation of the liver. Patients were originally undergoing EUS evaluation for evaluation of suspected subepithelial lesions. Receives: Diagnostic Test: EUS- share wave of the liver |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of EUS-share of the liver
Evaluation of the correlation between transient elastography, EUS-elastography of the liver, EUS-guided liver biopsy and EUS-guided share wave of the liver
Measured: 2 months
Diagnostic accuracy of EUS-share wave of the liver
Evaluate the diagnostic accuracy of EUS- share wave of the liver for predicting liver cirrhosis. Receiver operating characteristic curve development with evaluation of the sensitivity, specificity, PPV and NPV of EUS-guided share wave of the liver to predict liver cirrhosis.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2020
- Study start1 Mar 2020
- Primary completion15 Jun 2022
- Study completion15 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver CirrhosisStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Ecuatoriano de Enfermedades Digestivas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlos Robles-Medranda, MD FASGE, Principal investigator, Ecuadorian Institute of Digestive Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04644055
- Sponsor's protocol ID
- IECED-110520
- Status last verified
- Sep 2023
- First submitted
- 19 Nov 2020
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Robles-Medranda C, Oleas R, Puga-Tejada M, Valero M, Valle RD, Ospina J, Pitanga-Lukashok H. Results of liver and spleen endoscopic ultrasonographic elastography predict portal hypertension secondary to chronic liver disease. Endosc Int Open. 2020 Nov;8(11):E1623-E1632. doi: 10.1055/a-1233-1934. Epub 2020 Oct 22.
PubMed 33140018
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Ultrasound Share-wave for the Evaluation of Patients With Chronic Liver Disease
- ClinicalTrials.gov ID
- NCT04644055
- Acronym / sponsor ID
- IECED-110520
- Conditions
- Liver Cirrhosis
- Keywords
- liver cirrhosis; fibrosis, endoscopic ultrasonography, elasticity imaging, tissue
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Instituto Ecuatoriano de Enfermedades DigestivasUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 15 Apr 2023 (actual)
- First posted
- 25 Nov 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.
Patients with chronic liver disease may develop progressive hepatic fibrosis. Liver cirrhosis should be detected at the early stages in order to avoid the complications related to these two conditions.
The diagnostic work-up of patients with chronic liver disease includes less-invasive diagnostic methods such as abdominal ultrasonography, transient elastography, upper endoscopy; and more invasive procedures, mainly liver biopsy and portal pressure gradient measurement, both with associated risks.
Endoscopic ultrasound offers a benefit of including all diagnostic work-up in a single procedure. The investigators previously demonstrated that EUS-elastography of the liver and spleen is reliable marker for predicting liver cirrhosis.
Recently, a quantitative evaluation of fibrosis using share wave elastography was introduced, mainly for the pancreatic tumor fibrosis measurement (2). Elastography measures the elasticity of tissues (hardness); whereas share wave measures the tissue elasticity as the elastic modulus by measuring the share wave velocity. Share wave measurement will be performed with the Arietta 850 Endoscopic ultrasound console using a linear ultrasound video gastroscope EUS-J10 (Pentax Medical, Hoya Corp, Japan). The investigators proposed the EUS-share wave of the liver as a reliable diagnostic marker in patients with liver cirrhosis.
Detailed description
A non-blinded, prospective trial. Primary disease condition: liver cirrhosis Keywords: Liver Cirrhosis; Fibrosis; Endoscopic Ultrasonography; Elasticity Imaging, Tissue.
Study Design: Observational study model: a non-blinded, non-randomized, prospective trial Time perspective: prospective Enrollment type: actual Number of subjects: 16 participants Number of groups/cohorts: 2 cohorts Target follow-up duration: 6 months
Based on the proportion of patients with the liver strain histogram (LSH) >87.40 among cirrhosis (87.5%) and control cases (31.0%) described by Robles-Medranda et al. (1), the investigators calculated eight patients per study group with a 5% and 20% of alpha and beta error respectively, with an 80% of power statistic.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic liver disease with liver cirrhosis | – | Diagnostic Test: EUS- share wave of the liverEvaluation of the right and left hepatic lobe with EUS-guided share wave evaluation. All patients with chronic liver disease will have a transient elastography evaluation, EUS- elastography of the liver and an EUS-guided liver biopsy. |
| Control patients | – | Diagnostic Test: EUS- share wave of the liverPatients without history of chronic liver disease after clinical and transient elastography evaluation will be submitted for EUS-guided share wave evaluation of the liver. Patients were originally undergoing EUS evaluation for evaluation of suspected subepithelial lesions. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Performed at Instituto Ecuatoriano de Enfermedades Digestivas (IECED), an academic tertiary center in Guayaquil, Ecuador. Patients will be invited to participate during outpatient clinic visits. All consecutive participants need to be ≥18 years old and has a history of chronic liver disease with histological proven liver cirrhosis. Control patients will be patients without history of chronic liver disease and will be included following a transient elastography test within normal limits.
Key inclusion criteria (4 listed)
- Provided informed written consent
- Age greater than 18 years of age
- Confirmed diagnosis of chronic liver disease based on transient elastography
- Patients with EUS-guided liver biopsy
Key exclusion criteria (5 listed)
- History of uncontrolled coagulopathy
- Contraindications to EUS-guided liver biopsy
- Pregnancy or nursing
- History of hepatocellular carcinoma
- Patients with equivocal transient elastography results
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- share wave of the liverEvaluation of the right and left hepatic lobe with EUS-guided share wave | Diagnostic test | Chronic liver disease with liver cirrhosis, Control patients |
Primary outcome
Correlation of EUS-share of the liver
Time frame: 2 months
Evaluation of the correlation between transient elastography, EUS-elastography of the liver, EUS-guided liver biopsy and EUS-guided share wave of the liver
Diagnostic accuracy of EUS-share wave of the liver
Time frame: 2 months
Evaluate the diagnostic accuracy of EUS- share wave of the liver for predicting liver cirrhosis. Receiver operating characteristic curve development with evaluation of the sensitivity, specificity, PPV and NPV of EUS-guided share wave of the liver to predict liver cirrhosis.
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 28 Sep 2023.
- Results publication: PubMed 33140018Robles-Medranda C, Oleas R, Puga-Tejada M, Valero M, Valle RD, Ospina J, Pitanga-Lukashok H. Results of liver and spleen endoscopic ultrasonographic elastography predict portal hypertension secondary to chronic liver disease. Endosc Int Open. 2020 Nov;8(11):E1623-E1632. doi: 10.1055/a-1233-1934. Epub 2020 Oct 22.
- 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.
Carlos Robles-Medranda, MD FASGE principal investigator
Ecuadorian Institute of Digestive Diseases
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 Instituto Ecuatoriano de Enfermedades Digestivas at 1 site in Ecuador.
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 5 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 28 Sep 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 Ecuador. 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?
Correlation of EUS-share of the liver (time frame: 2 months). 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?
On the ClinicalTrials.gov record for NCT04644055, which also lists 1 linked publication.
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 28 Sep 2023.