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Cucchetti A.,University of Bologna | Trevisani F.,University of Bologna | Pecorelli A.,University of Bologna | Erroi V.,University of Bologna | And 17 more authors.
Journal of Hepatology | Year: 2014

Background & Aims Lead-time is the time by which diagnosis is anticipated by screening/surveillance with respect to the symptomatic detection of a disease. Any screening program, including surveillance for hepatocellular carcinoma (HCC), is subject to lead-time bias. Data regarding lead-time for HCC are lacking. Aims of the present study were to calculate lead-time and to assess its impact on the benefit obtainable from the surveillance of cirrhotic patients. Methods One-thousand three-hundred and eighty Child-Pugh class A/B patients from the ITA.LI.CA database, in whom HCC was detected during semiannual surveillance (n = 850), annual surveillance (n = 234) or when patients came when symptomatic (n = 296), were selected. Lead-time was estimated by means of appropriate formulas and Monte Carlo simulation, including 1000 patients for each arm. Results The 5-year overall survival after HCC diagnosis was 32.7% in semiannually surveilled patients, 25.2% in annually surveilled patients, and 12.2% in symptomatic patients (p <0.001). In a 10-year follow-up perspective, the median lead-time calculated for all surveilled patients was 6.5 months (7.2 for semiannual and 4.1 for annual surveillance). Lead-time bias accounted for most of the surveillance benefit until the third year of follow-up after HCC diagnosis. However, even after lead-time adjustment, semiannual surveillance maintained a survival benefit over symptomatic diagnosis (number of patients needed to screen = 13), as did annual surveillance (18 patients). Conclusions Lead-time bias is the main determinant of the short-term benefit provided by surveillance for HCC, but this benefit becomes factual in a long-term perspective, confirming the clinical utility of an anticipated diagnosis of HCC.


Giannini E.G.,University of Genoa | Savarino V.,University of Genoa | Farinati F.,University of Padua | Ciccarese F.,Policlinico San Marco | And 7 more authors.
Liver International | Year: 2013

Background: The role of clinically significant portal hypertension on the prognosis of cirrhotic patients undergoing hepatic resection for hepatocellular carcinoma (HCC) is debated. Aims: In this study, our aim was to assess the role of clinically significant portal hypertension after hepatic resection for HCC in patients with cirrhosis. Methods: We assessed the prognostic role of the presence of clinically significant portal hypertension (oesophageal/gastric varices/portal hypertensive gastropathy or a platelet count <100 × 109/L associated with splenomegaly) in 152 patients with compensated cirrhosis who underwent hepatic resection for HCC at the Italian Liver Cancer centres. Survival rates were assessed in the whole series, in the subgroup of Child-Pugh score 5 patients with uninodular HCC ≤5 cm, and in Child-Pugh score 5 patients with uninodular HCC ≤2 cm and normal bilirubin. Results: Median survival was similar in patients with and without clinically significant portal hypertension (79 vs 77 months, P = 0.686). Child-Pugh score 5 was the only variable significantly associated with survival by Cox multiple regression (P = 0.007). In Child-Pugh score 5 patients with single HCC ≤5 cm or in those with single HCC ≤2 cm and normal bilirubin, there was no survival difference between patients with and without clinically significant portal hypertension (median survival: 94 vs 78 months, P = 0.121 and >100 vs 86 months, P = 0.742). Conclusions: Presence of clinically significant portal hypertension has no influence on survival of patients with well-compensated cirrhosis undergoing hepatic resection for HCC. © 2013 John Wiley & Sons A/S.


Giannini E.G.,University of Genoa | Farinati F.,University of Padua | Ciccarese F.,Policlinico San Marco | Pecorelli A.,University of Bologna | And 7 more authors.
Hepatology | Year: 2015

The prognosis of untreated patients with hepatocellular carcinoma (HCC) is heterogeneous, and survival data were mainly obtained from control arms of randomized studies. Clinical practice data on this topic are urgently needed, so as to help plan studies and counsel patients. We assessed the prognosis of 600 untreated patients with HCC managed by the Italian Liver Cancer Group. Prognosis was evaluated by subdividing patients according to the Barcelona Clinic Liver Cancer (BCLC) classification. We also assessed the main demographic, clinical, and oncological determinants of survival in the subgroup of patients with advanced HCC (BCLC C). Advanced (BCLC C: n=138; 23.0%) and end-stage HCC (BCLC D; n=210; 35.0%) represented the majority of patients. Overall median survival was 9 months, and the principal cause of death was tumor progression (n=279; 46.5%). Patients' median survival progressively and significantly decreased as BCLC stage worsened (BCLC 0: 38 months; BCLC A: 25 months; BCLC B: 10 months; BCLC C: 7 months; BCLC D: 6 months; P<0.0001). Female gender (hazard ratio [HR]=0.55; 95% confidence interval [CI]=0.33-0.90; P=0.018), ascites (HR=1.81; 95% CI=1.21-2.71; P=0.004), and multinodular (>3) HCC (HR=1.79; 95% CI=1.21-2.63; P=0.003) were independent predictors of survival in patients with advanced HCC (BCLC C). Conclusion: BCLC adequately predicts the prognosis of untreated HCC patients. In untreated patients with advanced HCC, female gender, clinical decompensation of cirrhosis, and multinodular tumor are independent prognostic predictors and should be taken into account for patient stratification in future therapeutic studies. © 2014 by the American Association for the Study of Liver Diseases.


PubMed | University of Padua, University of Genoa, Marche Polytechnic University, Policlinico San Marco and 13 more.
Type: Journal Article | Journal: Liver international : official journal of the International Association for the Study of the Liver | Year: 2016

Epidemiology of hepatocellular carcinoma is changing worldwide. This study aimed at evaluating the changing scenario of aetiology, presentation, management and prognosis of hepatocellular carcinoma in Italy during the last 15years.Retrospective analysis of the ITA.LI.CA (Italian Liver Cancer) database including 5192 hepatocellular carcinoma patients managed in 24 centres from 2000 to 2014. Patients were divided into three groups according to the date of cancer diagnosis (2000-2004, 2005-2009 and 2010-2014).The main results were as follows: (i) progressive patient aging; (ii) progressive expansion of non-viral cases and, namely, of metabolic hepatocellular carcinomas; (iii) increasing proportion of hepatocellular carcinoma diagnosed during a correct (semi-annual) surveillance programme; (iv) favourable cancer stage migration; (v) increased use of radiofrequency ablation to the detriment of percutaneous ethanol injection; (vi) improved outcomes of ablative and transarterial treatments; (vii) improved overall survival (adjusted for the lead time in surveyed patients), particularly after 2009, of both viral and non-viral patients presenting with an early- or intermediate-stage hepatocellular carcinoma.During the last 15years several aetiological and clinical features of hepatocellular carcinoma patients have changed, as their management. The observed improvement of overall survival was owing both to the wider use of semi-annual surveillance, expanding the proportion of tumours that qualified for curative treatments, and to the improved outcome of loco-regional treatments.


PubMed | University of Padua, University of Genoa, Marche Polytechnic University, Policlinico San Marco and 12 more.
Type: | Journal: Liver international : official journal of the International Association for the Study of the Liver | Year: 2016

The Barcelona Clinic Liver Cancer intermediate stage (BCLC-B) of hepatocellular carcinoma (HCC) includes extremely heterogeneous patients in terms of tumour burden and liver function. Transarterial-chemoembolization (TACE) is the first-line treatment for these patients although it may be risky/useless for someone, while others could undergo curative treatments. This study assesses the treatment type performed in a large cohort of BCLC-B patients and its outcome.Retrospective analysis of 485 consecutive BCLC-B patients from the ITA.LI.CA database diagnosed with nave HCC after 1999. Patients were stratified by treatment.29 patients (6%) were lost to follow-up before receiving treatment. Treatment distribution was: TACE (233, 51.1%), curative treatments (145 patients, 31.8%), sorafenib (18, 3.9%), other (39, 8.5%), best supportive care (BSC) (21, 4.6%). Median survival (95% CI) was 45months (37.4-52.7) for curative treatments, 30 (24.7-35.3) for TACE, 14 (10.5-17.5) for sorafenib, 14 (5.2-22.7) for other treatments and 10 (6.0-14.2) for BSC (P<.0001). Independent prognosticators were gender and treatment. Curative treatments reduced mortality (HR 0.197, 95%CI: 0.098-0.395) more than TACE (HR 0.408, 95%CI: 0.211-0.789) (P<.0001) as compared with BSC. Propensity score matching confirmed the superiority of curative therapies over TACE.In everyday practice TACE represents the first-line therapy in an half of patients with nave BCLC-B HCC since treatment choice is driven not only by liver function and nodule characteristics, but also by contraindications to procedures, comorbidities, age and patient opinion. The treatment type is an independent prognostic factor in BCLC-B patients and curative options offer the best outcome.


PubMed | University of Padua, University of Genoa, Marche Polytechnic University, Policlinico San Marco and 12 more.
Type: Journal Article | Journal: The American journal of gastroenterology | Year: 2016

The Barcelona Clinic Liver Cancer (BCLC) intermediate stage (BCLC B) includes a heterogeneous population of patients with hepatocellular carcinoma (HCC). Recently, in order to facilitate treatment decisions, a panel of experts proposed to subclassify BCLC B patients. In this study, we aimed to assess the prognostic capability of the BCLC B stage reclassification in a large cohort of patients with untreated HCC managed by the Italian Liver Cancer Group.We assessed the prognosis of 269 untreated HCC patients observed in the period 1987-2012 who were reclassified according to the proposed subclassification of the BCLC B stage from stage B1 to stage B4. We evaluated and compared the survival of the various substages.Median survival progressively decreased from stage B1 (n=65, 24.2%: 25 months) through stages B2 (n=105, 39.0%: 16 months) and B3 (n=22, 8.2%: 9 months), to stage B4 (n=77, 28.6%: 5 months; P<0.0001). Moreover, we observed a significantly different survival between contiguous stages (B1 vs. B2, P=0.0002; B2 vs. B3, P<0.0001; B3 vs. B4, P=0.0219). In multivariate analysis, the BCLC B subclassification (P<0.0001), MELD score (P=0.0013), and platelet count (P=0.0252) were independent predictors of survival.The subclassification of the intermediate-stage HCC predicts the prognosis of patients with untreated HCC. The prognostic figures identified in this study may be used as a benchmark to assess the efficacy of therapeutic intervention in the various BCLC B substages, whereas it remains to be established whether incorporation of the MELD score might improve the prognosis of treated patients.


Buoro S.,Laboratorio Analisi Chimico Cliniche | Gustinetti R.,Laboratorio Analisi Chimico Cliniche | Dominoni P.,Laboratorio Analisi Chimico Cliniche | Alessio M.G.,Laboratorio Analisi Chimico Cliniche | And 5 more authors.
Clinical Biochemistry | Year: 2012

Objective: To evaluate analytical performance of Sysmex UF-1000i for peritoneal fluid analysis. Methods: Functional sensitivity, imprecision, linearity and comparison studies were performed on peritoneal fluids. Results: Total imprecision was 1.6-4.7%, functional sensitivity 27/μL for white blood cell (WBC) and 32/μL for total nucleated cell (TNC) count. Linearity was excellent up to 983. cell/μL, carry-over < 0.2%, correlation with manual microscopy always greater than 0.992. Conclusion: The instrument exhibited optimal performance at the conventional WBC diagnostic thresholds. © 2012 The Canadian Society of Clinical Chemists.


Maglietta R.,CNR Institute of Intelligent Systems for Automation | Distaso A.,CNR Institute of Intelligent Systems for Automation | Piepoli A.,Unita Operativa di Gastroenterologia | Palumbo O.,Servizio di Genetica Medica | And 4 more authors.
Journal of Biomedical Informatics | Year: 2010

One of the major problems in genomics and medicine is the identification of gene networks and pathways deregulated in complex and polygenic diseases, like cancer. In this paper, we address the problem of assessing the variability of results of pathways analysis identified in different and independent genome wide expression studies, in which the same phenotypic conditions are assayed. To this end, we assessed the deregulation of 1891 curated gene sets in four independent gene expression data sets of subjects affected by colorectal cancer (CRC). In this comparison we used two well-founded statistical models for evaluating deregulation of gene networks. We found that the results of pathway analysis in expression studies are highly reproducible. Our study revealed 53 pathways identified by the two methods in all the four data sets analyzed with high statistical significance and strong biological relevance with the pathology examined. This set of pathways associated to single markers as well as to whole biological processes altered constitutes a signature of the disease which sheds light on the genetics bases of CRC. © 2009 Elsevier Inc. All rights reserved.


Caturelli E.,Unita Operativa di Gastroenterologia | Ghittoni G.,Medicine VI Interventional Ultrasound | Ranalli T.V.,Unita Operativa di Anatomia Patologica | Gomes V.V.,Unita Operativa di Anatomia Patologica
British Journal of Radiology | Year: 2011

Nodular regenerative hyperplasia (NRH) is an uncommon liver disease characterised histologically by numerous small hyperplastic nodules that are not separated by fibrotic tissue. It is thought to be the result of obliterative vasculopathy, and it has been associated with chronic use of medications, toxic substances and a wide variety of systemic diseases. Imaging diagnosis of early-stage NRH remains problematic. The nodules are rarely discerned and their appearance and behaviour before and after contrast medium administration are heterogeneous and not specific. A review of the literature shows that ultrasound has succeeded on occasion in revealing small focal liver lesions in patients with NRH. To our knowledge, there has been no published data on the performance in this setting of last-generation ultrasound scanners and techniques such as contrast-enhanced ultrasound (CEUS). The question is an important one because abdominal ultrasound is widely used as a first-line imaging technique for the evaluation of liver disease, and this makes it particularly suitable as a potential tool for the early diagnosis of NRH. Owing to the prolonged subclinical period and the limited help provided by imaging, the diagnosis in vivo of NRH is currently frequently missed, and it is still made exclusively on the basis of liver biopsy. In conclusion, this report describes 4 cases of biopsy-proven NRH that have been diagnosed over the past 2 years by our group. All were characterised by known comorbidities that confer a predisposition to NRH and by a peculiar parenchymal ultrasound pattern that we refer to as the "atoll sign". © 2011 The British Institute of Radiology.


Ghittoni G.,Unita Operativa Medicina VI | Caturelli E.,Unita Operativa di Gastroenterologia | Viera F.T.,Unita Operativa Medicina VI
Abdominal Imaging | Year: 2010

It is well-known that biliary duct invasion with intraluminal growth is one of the developmental patterns of primary liver tumors, and macroscopic intrabiliary growth of liver metastases in colorectal cancer is found with high frequency. Surgical treatment is the only potential curative therapy. However, many patients die of intrahepatic and/or extrahepatic recurrence after the resection. One of the causes of high recurrence rate after resective surgery, particularly surgical margin recurrences, is the invasion of biliary ducts mainly due to intraluminal tumor growth. We describe the first recorded case of a metastasis from colorectal cancer involving solely the common hepatic biliary duct, without invasion of contiguous liver parenchyma. A correct diagnosis was obtained by means of contrast enhanced ultrasound and ultrasound-guided fine needle aspiration biopsy. © Springer Science+Business Media, LLC 2009.

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