NCT04552236

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 17, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

September 17, 2020

Status Verified

September 1, 2020

Enrollment Period

1 year

First QC Date

September 11, 2020

Last Update Submit

September 16, 2020

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Predicting early HCC recurrence after treatment by Ultrasound elastography

    TO enhance surveillance and detect HCC recurrence as early as possible for further management

    Baseline

Interventions

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.

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with HCC and liver cirrhosis expected to visit Assiut university hospital to be treated

You may qualify if:

  • All patients with liver cirrhosis and HCC.

You may not qualify if:

  • Metastatic hepatic focal lesions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (11)

  • Villanueva A. Hepatocellular Carcinoma. N Engl J Med. 2019 Apr 11;380(15):1450-1462. doi: 10.1056/NEJMra1713263. No abstract available.

    PMID: 30970190BACKGROUND

  • Marasco 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.

    PMID: 30389551BACKGROUND

  • Attia 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.

    PMID: 27363528BACKGROUND

  • Gennisson 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.

    PMID: 23619292BACKGROUND

  • Shiina 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.

    PMID: 25805059BACKGROUND

  • Roulot 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.

    PMID: 18222014BACKGROUND

  • Jiao 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.

    PMID: 28180192BACKGROUND

  • Conti 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.

    PMID: 26973405BACKGROUND

  • Grgurevic 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.

    PMID: 29028279BACKGROUND

  • European 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.

    PMID: 22424438BACKGROUND

  • Ho 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.

    PMID: 27974549BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Central Study Contacts

Reem El shazly

CONTACT

+201014122696saadreem89@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

September 11, 2020

First Posted

September 17, 2020

Study Start

January 1, 2021

Primary Completion

January 1, 2022

Study Completion

February 1, 2022

Last Updated

September 17, 2020

Record last verified: 2020-09