Spleen Stiffness Measurement With FibroScan

A study testing Fibroscan® examination in people with Cirrhosis, run by Echosens at 7 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

FibroScan® (Echosens, Paris, France) is an active non implantable medical device marketed in Europe since December 2003 and is currently used in many countries. FibroScan® is an ultrasound-based vibration-controlled transient elastography (VCTE™) device dedicated to liver stiffness measurement (LSM). Read more about this study

Who is it for?: Ages 18 to 79 yearsHealthy volunteers can take part
Conditions the study is for: Cirrhosis
What is being tested?: Fibroscan® examination
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 403 participants
Where: 7 sitesin 4 countries
Study dates: Mar 2012to Jun 2017
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 79 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

All groups
Both gender, 18-79 years old
Patient able to give written informed consent form
Patient affiliated to a social security system.
Case group
Patient with chronic liver disease due to: hepatitis C virus, hepatitis B virus or Alcoholic Liver Disease and liver stiffness ≥ 14 kPa

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Patient with the following examination within 3 months of LSM and SSM: ultrasound examination, blood examination, gastroscopy examination and eventually an hepatic venous pressure gradient examination
Control groups
Patient with chronic liver disease due to: HCV, HBV or Alcoholic Liver Disease and liver stiffness < 14 kPa
Patients without chronic liver disease (Healthy Control subgroup)

Who cannot join

Patient unable or unwilling to provide written informed consent.
Consuming illness (HIV infection, malignancy).
Associated comorbidities: NASH, hemochromatosis, primary sclerosing cholangitis, primary biliary cirrhosis.
Antiviral treatment during the two months before inclusion.
Pacemaker or heart defibrillator.
Pregnancy.

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Liver transplantation.
BMI>35 kg/m2.
Serum Transaminases > 250 IU/L.
History of / or current βblockers treatment of OV.
Presence of ascites.
Previous endoscopic treatment of OV.
Patient with acute alcoholic hepatitis and associated jaundice (generally defined by total bilirubin ≥ 50 µmol/l).
Patient with hepatocellular carcinoma (HCC).
Unable or unwilling to undergo a liver stiffness measurement, a spleen stiffness measurement, an ultrasound examination, a blood examination or a gastroscopy examination.

Trial locations and contacts

7 sites in 4 countries.

Country

City, postcode or hospital

7 sites in 4 countries

France3 sites

CHU, Service Hépato-gastroentérologie
Angers, 49933
Hôpital Jean Verdier, Service Hépato-gastroentérologie
Bondy, 93140
Hôpital Haut-Lévêque, Service Hépato-gastroentérologie et Oncologie digestive
Pessac, 33604

Other trials in France

Italy2 sites

Department of Clinical Medicine, Policlinico S. Orsola Malpighi
Bologna, 40138
Seconda Divisione di Gastroenterologia Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico,
Milan, 20122

Other trials in Italy

Romania1 site

Iuliu Hatieganu University of Medicine and Pharmacy
Cluj-Napoca, 400162

Other trials in Romania

United Kingdom1 site

Royal Free Hospital, Pond Street
London, NW3 2QR

Other trials in United Kingdom

About this study

Official title: Feasibility and Performances of Spleen Stiffness Measurement as Surrogate Marker for Oesophageal Varices in Cirrhotic Patients.

Several clinical studies have shown the accuracy of LSM by FibroScan® to predict liver fibrosis.

Some other studies have already shown the good correlation between LSM, assessed by FibroScan® based on VCTE™ technology, and the presence of portal hypertension (PHT).

PHT is a clinical condition characterized by a high blood pressure in the portal vein and its tributaries and it is defined as a gradient between portal and systemic blood pressure > 6 mmHg.

The development of oesophageal varices (OV) in cirrhotic patients, as well as their potential bleeding, represent one of the most severe and life-threatening complication of cirrhosis.

Upper endoscopy is the best diagnostic tool for detecting the presence of OV, gastric varices or congestive gastropathy, for estimating the grade of OV and for the recognition of the presence of red color signs and wale marks or other indicators of high risk for bleeding.

However these two methods are quite invasive and associated with some risks; at the same time, not all cirrhotic patients present OV at endoscopic screening.

The aim of this study is the validation of SSM, assessed by a FibroScan® with acquisition parameters and algorithm optimized for SSM, as surrogate noninvasive marker for the presence of OV in liver cirrhosis patients.

Conditions: Cirrhosis
Being tested: Fibroscan® examination
Keywords: Cirrhotic patients, Fibroscan, Liver Stiffness Measurement, Oesophageal Varices, Portal Hypertension, Spleen Stiffness Measurement
Medical subject headings: Fibrosis, Esophageal and Gastric Varices, Hypertension, Portal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Fibroscan® examinationDevice
Each patient undergo 1 LSM and at least 1 SSM (2 in more if the patient accept to participate at the ancillary study (intra and inter operator reproducibility of SSM).

Study groups in NCT02180113
Study group	Role	What they receive
Fibroscan®	Other	Fibroscan® is an active non implantable medical device using ultrasound. It has been designed to measure liver stiffness in a painless, rapid and non invasive manner. It is a diagnostic aid tool. In this study, Spleen Stiffness Measurement will be assessed using a dedicated FibroScan® device which has been developed specifically to assess spleen stiffness. Receives: Device: Fibroscan® examination

What is being measured

The primary outcome is the main question the study is designed to answer.

Selection of patient with cirrhosis using LSM ≥ 14 kPa (kilopascal)
Measured: Up to 36 month

Secondary outcomes (1)

Diagnosis of large OV with an sensitivity of 95% and an acceptable lower bound of 85%
Measured: Up to 36 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2012Jun 2017

First posted2 Jul 2014 (estimated)
Study startMar 2012
Primary completionJan 2017
Study completionJun 2017

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 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: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 403 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02180113
Sponsor's protocol ID: M116
Status last verified: Oct 2018
First submitted: 1 Jul 2014
Last updated: 10 Oct 2018
Results posted: No
Data monitoring committee: No

Publications

Stefanescu H, Marasco G, Cales P, Fraquelli M, Rosselli M, Ganne-Carrie N, de Ledinghen V, Ravaioli F, Colecchia A, Rusu C, Andreone P, Mazzella G, Festi D. A novel spleen-dedicated stiffness measurement by FibroScan(R) improves the screening of high-risk oesophageal varices. Liver Int. 2020 Jan;40(1):175-185. doi: 10.1111/liv.14228. Epub 2019 Sep 11.
PubMed 31444849

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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RecruitingObservational study
The Value of Spleen Thickness and Spleen Diameter for Gastroesophageal Varices Diagnosis in Compensated Cirrhosis
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Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
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All Cirrhosis trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Feasibility and Performances of Spleen Stiffness Measurement as Surrogate Marker for Oesophageal Varices in Cirrhotic Patients.
ClinicalTrials.gov ID: NCT02180113
Acronym / sponsor ID: M116
Conditions: Cirrhosis
Keywords: Cirrhotic patients, Fibroscan, Liver Stiffness Measurement, Oesophageal Varices, Portal Hypertension, Spleen Stiffness Measurement
Study type: Interventional
Recruitment status: Completed
Enrolment: 403 participants (actual)
Lead sponsor: EchosensIndustry (pharma, biotech, devices)
Study start: Mar 2012
Primary completion: Jan 2017 (actual)
Study completion: Jun 2017 (actual)
First posted: 2 Jul 2014 (estimated)
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.

Several clinical studies have shown the accuracy of LSM by FibroScan® to predict liver fibrosis.

Some other studies have already shown the good correlation between LSM, assessed by FibroScan® based on VCTE™ technology, and the presence of portal hypertension (PHT).

PHT is a clinical condition characterized by a high blood pressure in the portal vein and its tributaries and it is defined as a gradient between portal and systemic blood pressure > 6 mmHg.

The development of oesophageal varices (OV) in cirrhotic patients, as well as their potential bleeding, represent one of the most severe and life-threatening complication of cirrhosis.

However these two methods are quite invasive and associated with some risks; at the same time, not all cirrhotic patients present OV at endoscopic screening.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Fibroscan®	Other	Device: Fibroscan® examinationFibroscan® is an active non implantable medical device using ultrasound. It has been designed to measure liver stiffness in a painless, rapid and non invasive manner. It is a diagnostic aid tool. In this study, Spleen Stiffness Measurement will be assessed using a dedicated FibroScan® device which has been developed specifically to assess spleen stiffness.

Who may qualify

Ages: 18 to 79 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

All groups
Case group
Control groups

Key exclusion criteria (15 listed)

Patient unable or unwilling to provide written informed consent.
Consuming illness (HIV infection, malignancy).
Associated comorbidities: NASH, hemochromatosis, primary sclerosing cholangitis, primary biliary cirrhosis.
Antiviral treatment during the two months before inclusion.
Pacemaker or heart defibrillator.

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
Fibroscan® examinationEach patient undergo 1 LSM and at least 1 SSM (2 in more if the patient accept to participate at the ancillary study (intra and inter operator reproducibility of SSM).	Device	Fibroscan®

Primary outcome

Selection of patient with cirrhosis using LSM ≥ 14 kPa (kilopascal)
Time frame: Up to 36 month

1 secondary outcome

Diagnosis of large OV with an sensitivity of 95% and an acceptable lower bound of 85%
Time frame: Up to 36 month

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 10 Oct 2018.
Derived from this study: PubMed 31444849Stefanescu H, Marasco G, Cales P, Fraquelli M, Rosselli M, Ganne-Carrie N, de Ledinghen V, Ravaioli F, Colecchia A, Rusu C, Andreone P, Mazzella G, Festi D. A novel spleen-dedicated stiffness measurement by FibroScan(R) improves the screening of high-risk oesophageal varices. Liver Int. 2020 Jan;40(1):175-185. doi: 10.1111/liv.14228. Epub 2019 Sep 11.

Related trials for Cirrhosis

RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
Recruiting
Optimal Treatment Strategy for Spontaneous Bacterial Peritonitis
Spontaneous Bacterial Peritonitis, Paracentesis
RecruitingObservational study
The Value of Spleen Thickness and Spleen Diameter for Gastroesophageal Varices Diagnosis in Compensated Cirrhosis
Liver Cirrhosis, Gastroesophageal Varices
Recruiting
CirrhosisRx CDS System
Cirrhosis, Decision Support Systems, Clinical
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD

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.

Davide FESTI, Pr. principal investigator

Department of Clinical Medicine, Policlinico S. Orsola Malpighi, Bologna, Italy

Horia STEFANESCU, Dr. principal investigator

Iuliu Hatieganu University of Medicine and Pharmacy, Clu-Napoca, Romania

Victor de LEDINGHEN, Pr. principal investigator

Hôpital Haut-Lévêque, Service Hépato-gastroentérologie et Oncologie digestive, Pessac, France

7 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Fibroscan® examination in people with Cirrhosis, run by Echosens at 7 sites in 4 countries.

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 10 inclusion and 15 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 10 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in France, Italy, Romania, United Kingdom. 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?

Selection of patient with cirrhosis using LSM ≥ 14 kPa (kilopascal) (time frame: Up to 36 month). 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 NCT02180113, 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 10 Oct 2018.