Liver DiseasesConCLUDeNCT03811431
Contrast Enhanced Ultrasound Guidance Biopsy for the Diagnosis of Liver Tumors
A study testing Contrast enhanced ultrasound guided liver biopsy in people with Liver Diseases, run by Iuliu Hatieganu University of Medicine and Pharmacy at 1 site in Romania.
Trial summary
The main purpose of this study is to compare contrast-enhanced ultrasound guided liver biopsy (CEUS-LB) with conventional ultrasound guided liver biopsy (US-LB) in the diagnosis of liver tumors developed on a background of advanced chronic liver diseases. 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?
- Contrast enhanced ultrasound guided liver biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteRomania
- Study dates
- 1 Jan 2011to 1 Jan 2020
- 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
- presence of cirrhosis or other chronic liver disease (according to a liver stiffness evaluated by transient elastography higher than 10 kilopascals)
- Child-Pugh score no higher than B7 and absence of perihepatic ascites
- platelet count > 50.000 per mm3
- international normalized ratio < 1.6
Who cannot join
- tumors located tin sonography blind areas
- refuse to sign the informed consent
Trial locations and contacts
1 site in 1 country.
Romania1 site, 1 recruiting
- Recruiting
Regional Institute of Gastroenterology and Hepatology "Octavian Fodor"
Cluj-Napoca, Please Enter the State Or Province, 400126
Tudor Mocan, +40 799 861946, Mocan.Tudor@umfcluj.ro
Ioana Rusu, ioana.russu@yahoo.com
About this study
Official title: Real Time Contrast-enhanced Compared to Conventional Ultrasound Guided Biopsy in the Diagnosis of Hepatic Tumors on a Background of Advanced Chronic Liver Disease. A Prospective Clinical Study.
The main purpose of this study is to compare contrast-enhanced ultrasound guided liver biopsy (CEUS-LB) with conventional ultrasound guided liver biopsy (US-LB) in the diagnosis of liver tumors developed on a background of advanced chronic liver diseases. All patients referred to our department with a CT/MRI diagnosis of hepatic neoplasia will be randomly assigned to either CEUS-LB or US-LB. All LB will be performed by the same investigator. For the randomisation the flip coin technique will be used. One investigator without access to previous C/MRI/US report will do the randomization
Read the detailed description
A prospective parallel group clinical trial will be performed. The study protocol was implemented in our Institute starting January 2011 ending January 1 2020. During this period, all patients with a suspicion of primary liver neoplasia either on CT or MRI will be evaluated in different departments from our Institute for possible inclusion. Patients with a typical aspect of benign FLLs will not be included in the study. Patients fulfilling the following criteria: presence of cirrhosis or other chronic liver disease (according to a liver stiffness evaluated by transient elastography higher than 10 kilopascals), Child-Pugh score no higher than B7 and absence of perihepatic ascites, platelet count > 50.000 per mm3 or an international normalized ratio < 1.6; will be further on sent to the department of interventional ultrasound. ). All patients referred to interventional department will underwent a B-mode ultrasound (1 investigator) testing the feasibility of performing liver biopsy. At this time point the conspicuity of the tumors will be recorded into either poorly or not poorly visible. Included patients will be randomly divided by another investigator (T.M.) without access to the previous US, CT or MRI report into two groups: a group that will underwent US guided liver biopsy (USLB) and another one who will underwent CEUS guided liver biopsy (CEUSLB). The randomization will be made based of flip coin technique. The side of the coin (heads-USLB, tails CEUSLB) determined the assignment of each subject. All biopsies will be performed by the same investigator (Z.S.) with an experience of more than 8 years in ultrasound interventions. Patients assigned to USLB or CEUSLB will be blinded. The investigators assessing the outcomes will not be informed about the LB technique used in each patient. The reasons for performing biopsy will be either inconclusive CT/MRI findings , or patients with a typical pattern of HCC on CT/MRI in whom a histological diagnosis is necessary in order to start systemic therapy (sorafenib). Different from other major society's guidelines, in our country a histological diagnosis of HCC is mandatory in patients referred for sorafenib treatment. Patients with small FLLs (BCLC 0 or A) and typical aspect of HCC on CT/MRI will be sent directly to surgery or radiofrequency ablation according to EASL guidelines.
- Conditions
- Liver Diseases
- Being tested
- Contrast enhanced ultrasound guided liver biopsy
- Keywords
- contrast enhanced ultrasound guided liver biopsy, ultrasound guided liver biopsy, focal liver lesions, hepatocellular carcinoma, advanced chronic liver disease
- Medical subject headings
- Liver Diseases, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrast enhanced ultrasound guided liver biopsyProcedure or surgery
Also called Ultrasound
Conventional liver biopsy
| Study group | Role | What they receive |
|---|---|---|
| CEUS guidance | Experimental | SonoVue 2, 4 ml Receives: Procedure: Contrast enhanced ultrasound guided liver biopsy |
| Conventional US guidance | Experimental | No drugs Receives: Procedure: Contrast enhanced ultrasound guided liver biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients in whom contrast enhanced ultrasound guided liver biopsy leads to the final diagnosis as compared to conventional ultrasound guided liver biopsy. The final diagnosis will be assessed based on histological examination.
In patients in whom a final histological diagnosis can not be achieved with the use of contrast enhanced or ultrasound guidance a second liver biopsy will be considered if appropriate in the next 3-4 weeks. In cases where a second liver biopsy will be judged not to be necessary a follow-up using imaging techniques will be performed until a final diagnosis is reached.
Measured: From randomisation until the first documented histological diagnosis. In cases with a negative diagnosis based on histology imaging follow-up using CT or MRI will be carried on for a period of at least 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2019
- Study start1 Jan 2011
- Primary completion1 Jan 2020 (estimated)
- Study completion1 Jan 2020 (estimated)
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
- A prospective parallel group clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Iuliu Hatieganu University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tudor Mocan, Iuliu Hatieganu University of Medicine and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03811431
- Sponsor's protocol ID
- BIOPTICON
- Acronym
- ConCLUDe
- Status last verified
- Jan 2019
- First submitted
- 16 Jan 2019
- Last updated
- 22 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real Time Contrast-enhanced Compared to Conventional Ultrasound Guided Biopsy in the Diagnosis of Hepatic Tumors on a Background of Advanced Chronic Liver Disease. A Prospective Clinical Study.
- ClinicalTrials.gov ID
- NCT03811431
- Acronym / sponsor ID
- ConCLUDe / BIOPTICON
- Conditions
- Liver Diseases
- Keywords
- contrast enhanced ultrasound guided liver biopsy, ultrasound guided liver biopsy, focal liver lesions, hepatocellular carcinoma, advanced chronic liver disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Iuliu Hatieganu University of Medicine and PharmacyUniversity, hospital or other
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 1 Jan 2020 (estimated)
- First posted
- 22 Jan 2019 (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.
The main purpose of this study is to compare contrast-enhanced ultrasound guided liver biopsy (CEUS-LB) with conventional ultrasound guided liver biopsy (US-LB) in the diagnosis of liver tumors developed on a background of advanced chronic liver diseases. All patients referred to our department with a CT/MRI diagnosis of hepatic neoplasia will be randomly assigned to either CEUS-LB or US-LB. All LB will be performed by the same investigator. For the randomisation the flip coin technique will be used. One investigator without access to previous C/MRI/US report will do the randomization
Detailed description
A prospective parallel group clinical trial will be performed. The study protocol was implemented in our Institute starting January 2011 ending January 1 2020. During this period, all patients with a suspicion of primary liver neoplasia either on CT or MRI will be evaluated in different departments from our Institute for possible inclusion. Patients with a typical aspect of benign FLLs will not be included in the study. Patients fulfilling the following criteria: presence of cirrhosis or other chronic liver disease (according to a liver stiffness evaluated by transient elastography higher than 10 kilopascals), Child-Pugh score no higher than B7 and absence of perihepatic ascites, platelet count > 50.000 per mm3 or an international normalized ratio < 1.6; will be further on sent to the department of interventional ultrasound. ). All patients referred to interventional department will underwent a B-mode ultrasound (1 investigator) testing the feasibility of performing liver biopsy. At this time point the conspicuity of the tumors will be recorded into either poorly or not poorly visible. Included patients will be randomly divided by another investigator (T.M.) without access to the previous US, CT or MRI report into two groups: a group that will underwent US guided liver biopsy (USLB) and another one who will underwent CEUS guided liver biopsy (CEUSLB). The randomization will be made based of flip coin technique. The side of the coin (heads-USLB, tails CEUSLB) determined the assignment of each subject. All biopsies will be performed by the same investigator (Z.S.) with an experience of more than 8 years in ultrasound interventions. Patients assigned to USLB or CEUSLB will be blinded. The investigators assessing the outcomes will not be informed about the LB technique used in each patient. The reasons for performing biopsy will be either inconclusive CT/MRI findings , or patients with a typical pattern of HCC on CT/MRI in whom a histological diagnosis is necessary in order to start systemic therapy (sorafenib). Different from other major society's guidelines, in our country a histological diagnosis of HCC is mandatory in patients referred for sorafenib treatment. Patients with small FLLs (BCLC 0 or A) and typical aspect of HCC on CT/MRI will be sent directly to surgery or radiofrequency ablation according to EASL guidelines.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A prospective parallel group clinical trial
| Arm | Type | Receives |
|---|---|---|
| CEUS guidance | Experimental | Procedure: Contrast enhanced ultrasound guided liver biopsySonoVue 2, 4 ml |
| Conventional US guidance | Experimental | Procedure: Contrast enhanced ultrasound guided liver biopsyNo drugs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- presence of cirrhosis or other chronic liver disease (according to a liver stiffness evaluated by transient elastography higher than 10 kilopascals)
- Child-Pugh score no higher than B7 and absence of perihepatic ascites
- platelet count > 50.000 per mm3
- international normalized ratio < 1.6
Key exclusion criteria (2 listed)
- tumors located tin sonography blind areas
- refuse to sign the informed consent
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 |
|---|---|---|
| Contrast enhanced ultrasound guided liver biopsyAlso: UltrasoundConventional liver biopsy | Procedure or surgery | CEUS guidance, Conventional US guidance |
Primary outcome
Number of patients in whom contrast enhanced ultrasound guided liver biopsy leads to the final diagnosis as compared to conventional ultrasound guided liver biopsy. The final diagnosis will be assessed based on histological examination.
Time frame: From randomisation until the first documented histological diagnosis. In cases with a negative diagnosis based on histology imaging follow-up using CT or MRI will be carried on for a period of at least 12 months.
In patients in whom a final histological diagnosis can not be achieved with the use of contrast enhanced or ultrasound guidance a second liver biopsy will be considered if appropriate in the next 3-4 weeks. In cases where a second liver biopsy will be judged not to be necessary a follow-up using imaging techniques will be performed until a final diagnosis is reached.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2019.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contrast enhanced ultrasound guided liver biopsy in people with Liver Diseases, run by Iuliu Hatieganu University of Medicine and Pharmacy at 1 site in Romania.
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 2 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: status not confirmed, as of the sponsor's last update on 22 Jan 2019. 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 Romania. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tudor Mocan, MD (+40 799861946, Mocac.Tudor@umfcluj.ro), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients in whom contrast enhanced ultrasound guided liver biopsy leads to the final diagnosis as compared to conventional ultrasound guided liver biopsy. The final diagnosis will be assessed based on histological examination. (time frame: From randomisation until the first documented histological diagnosis. In cases with a negative diagnosis based on histology imaging follow-up using CT or MRI will be carried on for a period of at least 12 months.). 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 22 Jan 2019.