Hepatocellular CarcinomaNCT04552236
Evaluation of Liver Stiffness by Ultrasound Elastography for Predicting Early HCC Recurrence After Treatment
An observational study of Hepatocellular Carcinoma, run by Assiut University.
Trial summary
We aim to evaluate liver stiffness as a marker of severity and duration of the underlying liver disease to predict for early HCC recurrence after treatment. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Ultrasound ELastography
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2021to Feb 2022
- 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 50 to 80 years
- All sexes
- Adult, Older adult
Study population: Patients with HCC and liver cirrhosis expected to visit Assiut university hospital to be treated
Who may be able to join
- All patients with liver cirrhosis and HCC.
Who cannot join
- Metastatic hepatic focal lesions.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of Liver Stiffness by Ultrasound Elastography for Predicting Early Hepatocellular Carcinoma Recurrence After Treatment
We aim to evaluate liver stiffness as a marker of severity and duration of the underlying liver disease to predict for early HCC recurrence after treatment.
Read the detailed description
Hepatocellular carcinoma (HCC) is one of the most common cancers worldwide and contributes to enormous cancer-related deaths annually . Hepatocellular carcinoma is a frequent complication of liver disease. Early recurrence is mainly tumour or treatment-related .
Liver fibrosis stagging is essential to evaluate the expected prognosis against the concomitant therapies. Liver biopsy remain the gold standard for diagnosing liver fibrosis, however, it is limited due to the associated costs, invasiveness, and intra and inter observer variability. Patient discomfort, refusal and risk of complications. Ultrasound Elastography is a non-invasive imaging method liver fibrosis staging . Ultrasound Elastography is an imaging technology sensitive to tissue stiffness that was developed in the 1990s. It has been further developed and refined in recent years to enable quantitative assessment of tissue stiffness. Elastography methods take advantage of the changed elasticity of soft tissues resulting from specific pathological or physiological processes .
Elastography is an application, which produces the force coupled with a measurement system for the deformities caused by the force. There are several types of forces: 1. static compression induced externally by manual compression or internally by organ motion (heart, vessel, and breathing) 2. Dynamic compression induced with a continuous vibration at a given frequency 3. Impulse compression (transient vibration) induced externally by a transient mechanical impulse ( Fibroscan) or internally by an ultrasound impulse (ARFI, SWE), both compression types producing shear waves. While contrast-enhanced imaging is the first-line approach in the diagnosis of HCC, recent report show that the non-invasively measured stiffness of hepatic nodule could help to distinguish between malignant and benign liver lesions.
The treatment of HCC depends on the stage of liver disease and in many cases, curative resection is not possible. Therefore local ablative therapies, such as transarterial chemoembolization (TACE) and radiofrequency ablation (RFA), are considered viable therapeutic options . However, HCC might behave very differently and could show more or less of a response to local ablative treatment
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Ultrasound ELastography
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound ELastographyDevice
A standardized liver Elastography is critical to obtain reliable and accurate results . The patient is imaged in supine or slight 30 degrees left lateral decubitus position, with the right arm elevated above the head to open the intercostal spaces and improve the acoustic window to the liver . it is recommended to sample measurements in the right lobe , which has shown the most reliable results. Transducer pressure on the skin should be similar to regular anatomical B-mode imaging.
When using SWE techniques, the acoustic radiation force push pulse should be applied perpendicular to the liver capsule, with measurements obtained 4-5 cm deep to the skin and within a minimum 1-2 cm of liver parenchyma to limit refraction of the pulse. The operator should verify that these areas are free of vascular and biliary structures and rib shadows.
What is being measured
The primary outcome is the main question the study is designed to answer.
Predicting early HCC recurrence after treatment by Ultrasound elastography
TO enhance surveillance and detect HCC recurrence as early as possible for further management
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2020
- Study startJan 2021 (estimated)
- Primary completionJan 2022 (estimated)
- Study completionFeb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reem Mohamed Saad EL Shazly, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04552236
- Sponsor's protocol ID
- Ultrasound Elastography in HCC
- Status last verified
- Sep 2020
- First submitted
- 11 Sep 2020
- Last updated
- 17 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Villanueva A. Hepatocellular Carcinoma. N Engl J Med. 2019 Apr 11;380(15):1450-1462. doi: 10.1056/NEJMra1713263. No abstract available.
PubMed 30970190Marasco G, Colecchia A, Colli A, Ravaioli F, Casazza G, Bacchi Reggiani ML, Cucchetti A, Cescon M, Festi D. Role of liver and spleen stiffness in predicting the recurrence of hepatocellular carcinoma after resection. J Hepatol. 2019 Mar;70(3):440-448. doi: 10.1016/j.jhep.2018.10.022. Epub 2018 Oct 31.
PubMed 30389551Attia D, Bantel H, Lenzen H, Manns MP, Gebel MJ, Potthoff A. Liver stiffness measurement using acoustic radiation force impulse elastography in overweight and obese patients. Aliment Pharmacol Ther. 2016 Aug;44(4):366-79. doi: 10.1111/apt.13710. Epub 2016 Jun 30.
PubMed 27363528Gennisson JL, Deffieux T, Fink M, Tanter M. Ultrasound elastography: principles and techniques. Diagn Interv Imaging. 2013 May;94(5):487-95. doi: 10.1016/j.diii.2013.01.022. Epub 2013 Apr 22.
PubMed 23619292Shiina T, Nightingale KR, Palmeri ML, Hall TJ, Bamber JC, Barr RG, Castera L, Choi BI, Chou YH, Cosgrove D, Dietrich CF, Ding H, Amy D, Farrokh A, Ferraioli G, Filice C, Friedrich-Rust M, Nakashima K, Schafer F, Sporea I, Suzuki S, Wilson S, Kudo M. WFUMB guidelines and recommendations for clinical use of ultrasound elastography: Part 1: basic principles and terminology. Ultrasound Med Biol. 2015 May;41(5):1126-47. doi: 10.1016/j.ultrasmedbio.2015.03.009. Epub 2015 Mar 21.
PubMed 25805059Roulot D, Czernichow S, Le Clesiau H, Costes JL, Vergnaud AC, Beaugrand M. Liver stiffness values in apparently healthy subjects: influence of gender and metabolic syndrome. J Hepatol. 2008 Apr;48(4):606-13. doi: 10.1016/j.jhep.2007.11.020. Epub 2008 Jan 3.
PubMed 18222014Jiao Y, Dong F, Wang H, Zhang L, Xu J, Zheng J, Fan H, Gan H, Chen L, Li M. Shear wave elastography imaging for detecting malignant lesions of the liver: a systematic review and pooled meta-analysis. Med Ultrason. 2017 Jan 31;19(1):16-22. doi: 10.11152/mu-925.
PubMed 28180192Conti CB, Cavalcoli F, Fraquelli M, Conte D, Massironi S. Ultrasound elastographic techniques in focal liver lesions. World J Gastroenterol. 2016 Mar 7;22(9):2647-56. doi: 10.3748/wjg.v22.i9.2647.
PubMed 26973405Grgurevic I, Bokun T, Salkic NN, Brkljacic B, Vukelic-Markovic M, Stoos-Veic T, Aralica G, Rakic M, Filipec-Kanizaj T, Berzigotti A. Liver elastography malignancy prediction score for noninvasive characterization of focal liver lesions. Liver Int. 2018 Jun;38(6):1055-1063. doi: 10.1111/liv.13611. Epub 2017 Nov 3.
PubMed 29028279European Association For The Study Of The Liver; European Organisation For Research And Treatment Of Cancer. EASL-EORTC clinical practice guidelines: management of hepatocellular carcinoma. J Hepatol. 2012 Apr;56(4):908-43. doi: 10.1016/j.jhep.2011.12.001. No abstract available.
PubMed 22424438Ho DWH, Chan LK, Chiu YT, Xu IMJ, Poon RTP, Cheung TT, Tang CN, Tang VWL, Lo ILO, Lam PWY, Yau DTW, Li MX, Wong CM, Ng IOL. TSC1/2 mutations define a molecular subset of HCC with aggressive behaviour and treatment implication. Gut. 2017 Aug;66(8):1496-1506. doi: 10.1136/gutjnl-2016-312734. Epub 2016 Dec 14.
PubMed 27974549
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Liver Stiffness by Ultrasound Elastography for Predicting Early Hepatocellular Carcinoma Recurrence After Treatment
- ClinicalTrials.gov ID
- NCT04552236
- Acronym / sponsor ID
- Ultrasound Elastography in HCC
- Conditions
- Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2021 (estimated)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 17 Sep 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.
We aim to evaluate liver stiffness as a marker of severity and duration of the underlying liver disease to predict for early HCC recurrence after treatment.
Detailed description
Hepatocellular carcinoma (HCC) is one of the most common cancers worldwide and contributes to enormous cancer-related deaths annually . Hepatocellular carcinoma is a frequent complication of liver disease. Early recurrence is mainly tumour or treatment-related .
Liver fibrosis stagging is essential to evaluate the expected prognosis against the concomitant therapies. Liver biopsy remain the gold standard for diagnosing liver fibrosis, however, it is limited due to the associated costs, invasiveness, and intra and inter observer variability. Patient discomfort, refusal and risk of complications. Ultrasound Elastography is a non-invasive imaging method liver fibrosis staging . Ultrasound Elastography is an imaging technology sensitive to tissue stiffness that was developed in the 1990s. It has been further developed and refined in recent years to enable quantitative assessment of tissue stiffness. Elastography methods take advantage of the changed elasticity of soft tissues resulting from specific pathological or physiological processes .
Elastography is an application, which produces the force coupled with a measurement system for the deformities caused by the force. There are several types of forces: 1. static compression induced externally by manual compression or internally by organ motion (heart, vessel, and breathing) 2. Dynamic compression induced with a continuous vibration at a given frequency 3. Impulse compression (transient vibration) induced externally by a transient mechanical impulse ( Fibroscan) or internally by an ultrasound impulse (ARFI, SWE), both compression types producing shear waves. While contrast-enhanced imaging is the first-line approach in the diagnosis of HCC, recent report show that the non-invasively measured stiffness of hepatic nodule could help to distinguish between malignant and benign liver lesions.
The treatment of HCC depends on the stage of liver disease and in many cases, curative resection is not possible. Therefore local ablative therapies, such as transarterial chemoembolization (TACE) and radiofrequency ablation (RFA), are considered viable therapeutic options . However, HCC might behave very differently and could show more or less of a response to local ablative treatment
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with HCC and liver cirrhosis expected to visit Assiut university hospital to be treated
Key inclusion criteria (1 listed)
- All patients with liver cirrhosis and HCC.
Key exclusion criteria (1 listed)
- Metastatic hepatic focal lesions.
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 |
|---|---|---|
| Ultrasound ELastographyA standardized liver Elastography is critical to obtain reliable and accurate results . The patient is imaged in supine or slight 30 degrees left lateral decubitus position, with the right arm elevated above the head to open the intercostal spaces and improve the acoustic window to the liver . it is recommended to sample measurements in the right lobe , which has shown the most reliable results. Transducer pressure on the skin should be similar to regular anatomical B-mode imaging. When using SWE techniques, the acoustic radiation force push pulse should be applied perpendicular to the liver capsule, with measurements obtained 4-5 cm deep to the skin and within a minimum 1-2 cm of liver parenchyma to limit refraction of the pulse. The operator should verify that these areas are free of vascular and biliary structures and rib shadows. | Device | – |
Primary outcome
Predicting early HCC recurrence after treatment by Ultrasound elastography
Time frame: Baseline
TO enhance surveillance and detect HCC recurrence as early as possible for further management
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2020.
- Background: PubMed 30970190Villanueva A. Hepatocellular Carcinoma. N Engl J Med. 2019 Apr 11;380(15):1450-1462. doi: 10.1056/NEJMra1713263. No abstract available.
- Background: PubMed 30389551Marasco G, Colecchia A, Colli A, Ravaioli F, Casazza G, Bacchi Reggiani ML, Cucchetti A, Cescon M, Festi D. Role of liver and spleen stiffness in predicting the recurrence of hepatocellular carcinoma after resection. J Hepatol. 2019 Mar;70(3):440-448. doi: 10.1016/j.jhep.2018.10.022. Epub 2018 Oct 31.
- Background: PubMed 27363528Attia D, Bantel H, Lenzen H, Manns MP, Gebel MJ, Potthoff A. Liver stiffness measurement using acoustic radiation force impulse elastography in overweight and obese patients. Aliment Pharmacol Ther. 2016 Aug;44(4):366-79. doi: 10.1111/apt.13710. Epub 2016 Jun 30.
- Background: PubMed 23619292Gennisson JL, Deffieux T, Fink M, Tanter M. Ultrasound elastography: principles and techniques. Diagn Interv Imaging. 2013 May;94(5):487-95. doi: 10.1016/j.diii.2013.01.022. Epub 2013 Apr 22.
- Background: PubMed 25805059Shiina T, Nightingale KR, Palmeri ML, Hall TJ, Bamber JC, Barr RG, Castera L, Choi BI, Chou YH, Cosgrove D, Dietrich CF, Ding H, Amy D, Farrokh A, Ferraioli G, Filice C, Friedrich-Rust M, Nakashima K, Schafer F, Sporea I, Suzuki S, Wilson S, Kudo M. WFUMB guidelines and recommendations for clinical use of ultrasound elastography: Part 1: basic principles and terminology. Ultrasound Med Biol. 2015 May;41(5):1126-47. doi: 10.1016/j.ultrasmedbio.2015.03.009. Epub 2015 Mar 21.
- Background: PubMed 18222014Roulot D, Czernichow S, Le Clesiau H, Costes JL, Vergnaud AC, Beaugrand M. Liver stiffness values in apparently healthy subjects: influence of gender and metabolic syndrome. J Hepatol. 2008 Apr;48(4):606-13. doi: 10.1016/j.jhep.2007.11.020. Epub 2008 Jan 3.
- Background: PubMed 28180192Jiao Y, Dong F, Wang H, Zhang L, Xu J, Zheng J, Fan H, Gan H, Chen L, Li M. Shear wave elastography imaging for detecting malignant lesions of the liver: a systematic review and pooled meta-analysis. Med Ultrason. 2017 Jan 31;19(1):16-22. doi: 10.11152/mu-925.
- Background: PubMed 26973405Conti CB, Cavalcoli F, Fraquelli M, Conte D, Massironi S. Ultrasound elastographic techniques in focal liver lesions. World J Gastroenterol. 2016 Mar 7;22(9):2647-56. doi: 10.3748/wjg.v22.i9.2647.
- Background: PubMed 29028279Grgurevic I, Bokun T, Salkic NN, Brkljacic B, Vukelic-Markovic M, Stoos-Veic T, Aralica G, Rakic M, Filipec-Kanizaj T, Berzigotti A. Liver elastography malignancy prediction score for noninvasive characterization of focal liver lesions. Liver Int. 2018 Jun;38(6):1055-1063. doi: 10.1111/liv.13611. Epub 2017 Nov 3.
- Background: PubMed 22424438European Association For The Study Of The Liver; European Organisation For Research And Treatment Of Cancer. EASL-EORTC clinical practice guidelines: management of hepatocellular carcinoma. J Hepatol. 2012 Apr;56(4):908-43. doi: 10.1016/j.jhep.2011.12.001. No abstract available.
- Background: PubMed 27974549Ho DWH, Chan LK, Chiu YT, Xu IMJ, Poon RTP, Cheung TT, Tang CN, Tang VWL, Lo ILO, Lam PWY, Yau DTW, Li MX, Wong CM, Ng IOL. TSC1/2 mutations define a molecular subset of HCC with aggressive behaviour and treatment implication. Gut. 2017 Aug;66(8):1496-1506. doi: 10.1136/gutjnl-2016-312734. Epub 2016 Dec 14.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma, run by Assiut University.
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 1 inclusion and 1 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 17 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Reem El shazly (+201014122696, saadreem89@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predicting early HCC recurrence after treatment by Ultrasound elastography (time frame: Baseline). 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 NCT04552236, which also lists 11 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 17 Sep 2020.