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• W2938551645 abstract "HomeRadiologyVol. 291, No. 3 PreviousNext Reviews and CommentaryFree AccessEditorialIs It Time to Expand the Definition of Washout Appearance in LI-RADS?Kathryn J. Fowler , Claude B. SirlinKathryn J. Fowler , Claude B. SirlinAuthor AffiliationsFrom the Liver Imaging Group, University of California San Diego, 200 W Arbor Dr, San Diego, CA 92103.Address correspondence to K.J.F. (e-mail: [email protected]).Kathryn J. Fowler Claude B. SirlinPublished Online:Apr 16 2019https://doi.org/10.1148/radiol.2019190552MoreSectionsPDF ToolsImage ViewerAdd to favoritesCiteTrack CitationsPermissionsReprints ShareShare onFacebookTwitterLinked In See also the article by Kim and Choi et al in this issue.IntroductionSeveral imaging-based systems have been proposed for the assessment of hepatocellular carcinoma (HCC). In this issue of Radiology, Dr Kim and colleagues (1) highlight a primary challenge in developing an ideal imaging algorithm for HCC: achieving an appropriate balance between sensitivity and specificity in the diagnostic test. A system that focuses on sensitivity would by necessity have lower specificity, and vice versa. As exemplified by worldwide regional variations in HCC diagnostic criteria (2), the preference to err on the side of sensitivity or specificity boils down to an East versus West debate.In the United States, the main diagnostic algorithm and lexicon endorsed by the American College of Radiology and the American Association for the Study of Liver Disease is the Liver Imaging Reporting and Data System (LI-RADS). As cirrhosis is the main risk factor for the development of HCC in North America, resection is generally not an option due to poor functional reserve, high morbidity and/or mortality, and the inevitability of recurrence in the remnant liver. The only potential cure for HCC arising in the setting of advanced cirrhosis is transplantation. Patients with radiology-determined stage T2 HCC (a single HCC <5 cm or three or fewer HCCs <3 cm) may receive priority on transplantation waitlists, effectively bypassing others with end-stage liver disease. To maintain equipoise in the context of organ shortage, it is imperative to avoid false-positive diagnosis of HCC and to strive for near 100% specificity with imaging. LI-RADS was developed around this tenet.In other regions, such as Asia, the main risk factor for HCC is hepatitis B viral infection, which leads to HCC development with or without cirrhosis. In these regions, resection is a common curative option and sensitivity of detection tends to be the focus of diagnostic algorithms for HCC (eg, Asian Pacific Association for Study of Liver, Korean Liver Cancer Association–National Cancer Center). As such, these systems tend to emphasize the use of hepatobiliary phase imaging with gadoxetate disodium, which has been shown to be most sensitive for the detection of early HCC (2)—especially in patients with no or only mild cirrhosis in whom adequate hepatobiliary phase enhancement of the background liver can be achieved reliably.Worldwide, all systems agree on the combination of arterial phase hyperenhancement plus “washout” for the diagnosis of HCC. However, there are differences in the way that washout appearance is defined by different systems. LI-RADS restricts the assessment of “washout” to the portal venous phase only when using gadoxetate disodium. The rationale behind this restriction is that “washout” is a specific imaging feature of HCC, but transitional phase hypointensity is not. The appearance of hypointensity in the transitional phase may reflect hyperenhancement of the background liver rather than actual “washout” phenomenon. Transitional phase hypointensity may be seen with any observation with reduced or absent transporters for gadoxetate disodium, such as cholangiocarcinomas, hemangiomas, and some dysplastic nodules. Hence, there is concern that assessment of “washout” in the transitional phase might reduce specificity in the diagnosis of HCC.In this issue of Radiology, Kim et al (1) propose that the LI-RADS definition of washout be expanded to include transitional phase hypointensity to achieve higher sensitivity of HCC detection. The authors correctly frame the question with regard to the impact on specificity—the primary concern for LI-RADS. They find that this expanded washout definition improves sensitivity without significantly reducing specificity. On the surface this sounds like a strong argument for changing the LI-RADS definition; however, this merits closer inspection.Kim et al evaluated a consecutive series of patients undergoing gadoxetate disodium–enhanced MRI after suspicious nodules were detected with sonographic screening. This is a good starting point, expected to reflect the natural incidence of both benign and malignant nodules and allow generalizability of results. However, the final cohort was made more selective by first excluding observations with LR-M features, cysts, hemangiomas, focal scar, perfusion alteration, vascular anomaly, focal fat, confluent fibrosis, and pseudomasses. In clinical practice, the categorization of these entities is challenging and several of them, notably perfusion alterations and confluent fibrosis, may appear hypointense during the transitional phase or hepatobiliary phase due to reduction in or lack of functional hepatocytes (3). These entities may impact diagnostic specificity and are frequently encountered in practice but were not accounted for in this study. Patients who did not undergo surgical resection were further excluded from the final cohort, enriching the cohort in HCC and potentially introducing verification bias because transitional or hepatobiliary phase hypointensity might have been used clinically to select patients for surgery. Therefore, the reported specificity of the expanded washout criterion may be inflated and the actual risk of false-positive diagnosis in clinical practice underestimated in this study.In addition, with only 17 non-HCC lesions in 15 patients, the study may be underpowered to detect a specificity difference. Although the authors found no significant differences in specificity between the LI-RADS versus the expanded washout criteria (P = .47), the point estimate for specificity was reduced from 94% to 82%. A 12 percentage point reduction in estimated specificity is clinically meaningful and might have achieved statistical significance with a larger sample size. This is what the authors of a separate similar study reported. Joo et al (4) evaluated 387 nodules (292 HCCs, 15 non-HCC malignancies, and 80 benign entities) and found a significant difference in specificity when comparing portal venous phase–only washout with washout at the transitional or hepatobiliary phase after exclusion of patients with LR-1, LR-2, and LR-M observations (87% vs 97%, P = .002).In the context of transplantation, patients with stage T2 HCC are eligible for 22 Model for End-Stage Liver Disease (MELD) exception points, which places them at a higher priority on the transplant list than some other patients with elevated physiologic MELD scores (bypassing the “sickest first” model). The criteria for the imaging diagnosis of HCC to satisfy eligibility and priority for transplantation have not always been well defined. The diagnosis of HCC was traditionally left to institutional expertise. However, the results of this nonstandardized approach were not satisfactory. Freeman and colleagues (5) evaluated the Organ Procurement and Transplant Network database from 2002 to 2006 and found that up to 20% of patients receiving priority for stage T2 HCC did not have HCC at pathologic examination of explants, even in the absence of prior therapy leading up to transplantation. The results of that study provided strong evidence that specific criteria were needed. Recent data suggest that since the implementation of standardized criteria in 2013, among other changes in allocation policy, the rates of false-positive diagnosis have fallen to less than 1% (6). In the study by Kim et al (1), the expanded definition resulted in two additional false-positive diagnoses: a dysplastic nodule and a small intrahepatic cholangiocarcinoma. With a false-positive diagnosis, these two patients could be given priority over other far sicker patients, potentially taking from them a lifesaving opportunity. The high percentage of livers that go to patients with HCC remains a point of controversy, and the goal should be to achieve a false-positive rate of zero.Although high specificity is required for liver transplantation, the majority of patients with HCC either are not candidates for transplantation or do not reach sufficient priority on the wait list due to organ shortage. In these patients, a focus on specificity at the expense of sensitivity may delay appropriate management. Although resection is generally not an option for patients with cirrhosis, other treatment options provide benefit, including percutaneous ablations, radiation therapy, intra-arterial therapy, and emerging chemotherapeutic agents. Therefore, changes to LI-RADS that would improve sensitivity for diagnosis of HCC are warranted and have recently been undertaken. The newly updated American Association for the Study of Liver Disease–LI-RADS version 2018 criteria, for example, changed the criteria for the LR-5 category, which now applies to 10–19-mm observations with arterial phase hyperenhancement and “washout” even in the absence of antecedent US visibility or “capsule” (7). Early data indicate these changes improve sensitivity for small lesions by about 10 percentage points (8).The next version of LI-RADS, anticipated in 2021, will likely incorporate additional changes to features and the diagnostic algorithm. Hepatobiliary phase imaging features, for example, hepatobiliary phase hypointensity, could be upgraded from ancillary to major features or at least be given higher weighting than other ancillary features. Likewise, washout appearance may be expanded to include temporal reduction in enhancement during the transitional phase. These decisions, along with all changes, will be based on best available evidence, user feedback, and expert consensus. Researchers are encouraged to produce methodologically sound evidence to address the important gaps in knowledge and facilitate improvements in LI-RADS. Specific emphasis should be placed on testing hypotheses in appropriate consecutive at-risk cohorts, avoiding biases when possible, reporting of all relevant data to allow pooling of results, and the use of a standardized precise lexicon in publications focused on HCC diagnostic imaging criteria.Disclosures of Conflicts of Interest: K.J.F. disclosed no relevant relationships. C.B.S. Activities related to the present article: disclosed no relevant relationships. Activities not related to the present article: institution receives payment for board membership from AMRA, Guerbet, VirtualScopics, and Bristol Myers Squibb; instititution received payment for consultancy from GE Healthcare, Bayer, AMRA, Fulcrum Therapeutics, IBM/Watson Health, and Exact Sciences; institituion has grants/grants pending from Gilead, GE Healthcare, Siemens, GE MRI, Bayer, BE Digital, GE US, ACR Innovations, Philips, and Celgene; institution received payment for lectures including service on speakers bureaus from GE Healthcare and Bayer; institution received royalties from Woltors Kluwer Health; institution received payment for development of educational presentations from Medscape, Resoundant, and UpToDate; institution has lab service agreements with Enanta, ICON Medical Imaging, Gilead, Shire Virtualscopics, Intercept, Synageva, Takeda, Genzyme, Janssen, and NuSirt; has independent consulting contracts with Epigenomics and Arterys.References1. Kim DH, Choi SH, Kim SY, Kim MJ, Lee SS, Byun JH. Gadoxetic acid–enhanced MRI of hepatocellular carcinoma: value of washout in transitional and hepatobiliary phases. Radiology 2019;291:651–657. Link, Google Scholar2. Kim TH, Kim SY, Tang A, Lee JM. Comparison of international guidelines for noninvasive diagnosis of hepatocellular carcinoma: 2018 update. Clin Mol Hepatol doi: 10.3350/cmh.2018.0090. Published online February 14, 2019. Accessed April 1, 2019. Google Scholar3. Motosugi U, Ichikawa T, Sou H, et al. Distinguishing hypervascular pseudolesions of the liver from hypervascular hepatocellular carcinomas with gadoxetic acid–enhanced MR imaging. Radiology 2010;256(1):151–158. Link, Google Scholar4. Joo I, Lee JM, Lee DH, Jeon JH, Han JK. Retrospective validation of a new diagnostic criterion for hepatocellular carcinoma on gadoxetic acid–enhanced MRI: can hypointensity on the hepatobiliary phase be used as an alternative to washout with the aid of ancillary features? Eur Radiol 2019;29(4):1724–1732. Crossref, Medline, Google Scholar5. Freeman RB, Mithoefer A, Ruthazer R, et al. Optimizing staging for hepatocellular carcinoma before liver transplantation: a retrospective analysis of the UNOS/OPTN database. Liver Transpl 2006;12(10):1504–1511. Crossref, Medline, Google Scholar6. Harper AM, Edwards E, Washburn WK, Heimbach J. An early look at the Organ Procurement and Transplantation Network explant pathology form data. Liver Transpl 2016;22(6):757–764. Crossref, Medline, Google Scholar7. Chernyak V, Fowler KJ, Kamaya A, et al. Liver Imaging Reporting and Data System (LI-RADS) version 2018: imaging of hepatocellular carcinoma in at-risk patients. Radiology 2018;289(3):816–830. Link, Google Scholar8. Ren AH, Zhao PF, Yang DW, Du JB, Wang ZC, Yang ZH. Diagnostic performance of MR for hepatocellular carcinoma based on LI-RADS v2018, compared with v2017. J Magn Reson Imaging doi: 10.1002/jmri.26640. Published online January 15, 2019. Accessed April 1, 2019. Google ScholarArticle HistoryReceived: Mar 11 2019Revision requested: Mar 14 2019Revision received: Mar 19 2019Accepted: Mar 19 2019Published online: Apr 16 2019Published in print: June 2019 FiguresReferencesRelatedDetailsCited ByUtilization of a Machine Learning Algorithm for the Application of Ancillary Features to LI-RADS Categories LR3 and LR4 on Gadoxetate Disodium-Enhanced MRISeongkeunPark, JieunByun, Sook MinHwang2023 | Cancers, Vol. 15, No. 5Simplified LI-RADS for Hepatocellular Carcinoma Diagnosis at Gadoxetic Acid–enhanced MRIMinha Kwag, Sang Hyun Choi, Se Jin Choi, Jae Ho Byun, Hyung Jin Won, Yong Moon Shin, 16 August 2022 | Radiology, Vol. 305, No. 3Do transition and hepatobiliary phase hypointensity improve LI-RADS categorization as an alternative washout: a systematic review and meta-analysisJunhanPan, YufengTao, XiaopingChi, LiliYang, YanciZhao, FengChen2022 | European Radiology, Vol. 32, No. 8Profiling hepatocellular carcinoma aggressiveness with contrast-enhanced ultrasound and gadoxetate disodium-enhanced MRI: An intra-individual comparative study based on the Liver Imaging Reporting and Data SystemJieYang, HanyuJiang, KunlinXie, Mustafa R.Bashir, HaifengWan, JiayanHuang, YunQin, JieChen, QiangLu, BinSong2022 | European Journal of Radiology, Vol. 154Gadoxetic Acid-Based MRI for Decision-Making in Hepatocellular Carcinoma Employing Perfusion Criteria Only—A Post Hoc Analysis from the SORAMIC Trial Diagnostic CohortMaxSeidensticker, Ingo G.Steffen, IreneBargellini, ThomasBerg, AlbertoBenito, BernhardGebauer, RobertoIezzi, ChristianLoewe, MusturayKarçaaltincaba, MaciejPech, ChristianSengel, Ottovan Delden, VincentVandecaveye, Christoph J.Zech, JensRicke2022 | Current Oncology, Vol. 29, No. 2Evaluation of Primary Liver Cancers Using Hepatocyte‐Specific Contrast‐Enhanced MRI : Pitfalls and Potential TipsJae HyunKim, Jeong HeeYoon, IjinJoo, Jeong MinLee2021 | Journal of Magnetic Resonance Imaging, Vol. 53, No. 3LI-RADS and transplantation: challenges and controversiesGuilherme M.Cunha, Dorathy E.Tamayo-Murillo, Kathryn J.Fowler2021 | Abdominal Radiology, Vol. 46, No. 1The role of lesion hypointensity on gadobenate dimeglumine–enhanced hepatobiliary phase MRI as an additional major imaging feature for HCC classification using LI-RADS v2018 criteriaYaoZhang, WenjieTang, SidongXie, JingbiaoChen, LinqiZhang, DailinRong, SichiKuang, BingjunHe, JinWang2021 | European Radiology, Vol. 31, No. 10Diagnostic Performance of KLCA-NCC 2018 Criteria for Hepatocellular Carcinoma Using Magnetic Resonance Imaging: A Systematic Review and Meta-AnalysisDong HwanKim, BohyunKim, Seo YeonYoun, HokunKim, Joon-IlChoi2021 | Diagnostics, Vol. 11, No. 10Does quantitative assessment of arterial phase hyperenhancement and washout improve LI-RADS v2018–based classification of liver lesions?DanielStocker, Anton S.Becker, Borna K.Barth, StephanSkawran, MalwinaKaniewska, Michael A.Fischer, OlivioDonati, Caecilia S.Reiner2020 | European Radiology, Vol. 30, No. 5Comparison of guidelines for diagnosis of hepatocellular carcinoma using gadoxetic acid–enhanced MRI in transplantation candidatesSun KyungJeon, Jeong MinLee, IjinJoo, JeonginYoo, Jin-youngPark2020 | European Radiology, Vol. 30, No. 9Comparison of the diagnostic performance of imaging criteria for HCCs ≤ 3.0 cm on gadoxetate disodium-enhanced MRIJieunByun, Sang HyunChoi, Jae HoByun, So JungLee, So YeonKim, Hyung JinWon, Yong MoonShin, Pyo-NyunKim2020 | Hepatology International, Vol. 14, No. 4Accompanying This ArticleGadoxetic Acid–enhanced MRI of Hepatocellular Carcinoma: Value of Washout in Transitional and Hepatobiliary PhasesApr 16 2019RadiologyRecommended Articles Gadoxetic Acid–enhanced MRI of Hepatocellular Carcinoma: Value of Washout in Transitional and Hepatobiliary PhasesRadiology2019Volume: 291Issue: 3pp. 651-657Evidence Supporting LI-RADS Major Features for CT- and MR Imaging–based Diagnosis of Hepatocellular Carcinoma: A Systematic ReviewRadiology2017Volume: 286Issue: 1pp. 29-48Validation of a Diagnostic Algorithm for Hepatocellular Carcinoma at Gadoxetic Acid–enhanced MRIRadiology2021Volume: 300Issue: 1pp. 184-186Liver Imaging Reporting and Data System (LI-RADS) Version 2018: Imaging of Hepatocellular Carcinoma in At-Risk PatientsRadiology2018Volume: 289Issue: 3pp. 816-830LI-RADS Version 2018 Ancillary Features at MRIRadioGraphics2018Volume: 38Issue: 7pp. 1973-2001See More RSNA Education Exhibits Don't Get Washed Out: Atypical Manifestations of Hepatocellular CarcinomaDigital Posters2019The LI-RADS CT/MRI Lexicon, What Every Radiologist Should KnowDigital Posters2021Hepatocellular Carcinoma (HCC) in Evolution: Correlation with CEUS LI-RADSDigital Posters2020 RSNA Case Collection LI-RADS 5RSNA Case Collection2022LI-RADS 5RSNA Case Collection2021Focal nodular hyperplasia of the liverRSNA Case Collection2020 Vol. 291, No. 3 Metrics Altmetric Score PDF download" @default.
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