To compare the effectiveness of radio-frequency (RF) ablation with that of percutaneous ethanol injection in the treatment of small hepatocellular carcinoma (HCC).
Eighty-six patients with 112 small ...(< or = 3-cm-diameter) HCCs underwent RF ablation (42 patients with 52 tumors) or percutaneous ethanol injection (44 patients with 60 tumors). Therapeutic efficacy was evaluated with dual-phase spiral computed tomography performed at least 4 months after treatment.
Complete necrosis was achieved in 47 of 52 tumors with RF ablation (90%) and in 48 of 60 tumors with percutaneous ethanol injection (80%). These results were obtained with an average of 1.2 sessions per tumor with RF ablation and 4.8 sessions per tumor with percutaneous ethanol injection. One major complication (hemothorax that required drainage) and four minor complications (intraperitoneal bleeding, hemobilia, pleural effusion, cholecystitis) occurred in patients treated with RF ablation; no complications occurred in patients treated with percutaneous ethanol injection.
RF ablation results in a higher rate of complete necrosis and requires fewer treatment sessions than percutaneous ethanol injection. However, the complication rate is higher with RF ablation than with percutaneous ethanol injection. RF ablation is the treatment of choice for most patients with HCC.
To evaluate the damage caused by microwave ablation to vessels inside and outside the ablation zone in an in vivo swine model.
Four pigs underwent microwave liver ablation with a 2.45-GHz generator ...and a 14-gauge water-cooled antenna with a miniature choke. Each animal underwent four 15-minute microwave ablations (two at 40 W, two at 60 W). Mean minimum and maximum diameters of ablation areas were calculated on gross pathologic and histologic examination. At minimum, a whole-mount section and two to four specimens were obtained from each ablation and stained with hematoxylin and eosin. Specimens were analyzed to verify the presence of damaged vessels in and outside the ablation area.
Mean ablation diameters at gross pathologic examination, including the hemorrhagic halo, were 3.1 cm ± 0.5 at 40 W and 3.6 cm ± 1.1 at 60 W. All ablation zones presented a characteristic pattern consisting of three concentric zones: (i) a central area consisting of coagulative necrosis (mean maximum diameter, 8.5 mm ± 2.6), (ii) a larger area characterized by irreversibly damaged hepatocytes (mean maximum thickness, 11.7 mm ± 3.4), and (iii) a hemorrhagic halo. Twenty-one veins outside the ablation zone were evaluated (mean diameter, 5.6 mm), three of which (14%) showed diffuse endothelial damage. All three represented a continuation of a portal vein within the ablation area.
In a small percentage of microwave ablation cases, endothelial damage can extend from a portal vessel included in the ablation zone to a segment of the vessel situated outside the ablation zone. Further investigation of the clinical significance of this finding is needed.
Surveillance for hepatocellular carcinoma (HCC) in high-risk patients with semiannual ultrasound examinations is advocated by all international guidelines. However, as long as the identification of ...the population to be screened and the surveillance programs are not well implemented, the real-life impact of HCC surveillance in reducing mortality for HCC cannot be known. We propose a new approach that promotes the identification of cirrhotic patients by primary care physicians (PCPs) and referral of patients to the hepatologist for surveillance. Surveillance should be incorporated, when feasible, in a hub and spoke model of comprehensive hepatology care. Training PCPs to identify cirrhotic patients and performing surveillance in a subspecialist setting are equally important to improve the effectiveness of real-life surveillance and to decrease HCC mortality over time.
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•Glecaprevir/pibrentasvir combination has demonstrated excellent SVR rates (99.2%) in this real-world study in Italy.•Male gender (0.022) and HCV genotype3 (0.046) were associated ...with the lowest rates of SVR after 8-week G/P treatment.•8.3% of the patients reported mild adverse events and 0.7% of them prematurely withdrew antiviral treatment.
The efficacy and safety of glecaprevir/pibrentasvir (G/P) for patients infected with hepatitis C virus (HCV) have only been investigated in clinical trials, with no real-world data currently available. The aim of our study was to investigate the effectiveness and safety of G/P in a real-world setting.
All patients with HCV consecutively starting G/P between October 2017 and January 2018 within the NAVIGATORE-Lombardia Network were analyzed. G/P was administered according to drug label (8, 12 or 16 weeks). Fibrosis was staged either histologically or by liver stiffness measurement. Sustained virological response (SVR) was defined as undetectable HCV-RNA 12 weeks after the end of treatment.
A total of 723 patients (50% males) were treated with G/P, 89% for 8 weeks. The median age of our cohort was 58 years, with a median body mass index of 23.9 kg/m2, and median liver stiffness measurement of 6.1 kPa; 84% were F0-2 and 16% were interferon-experienced. Median HCV-RNA was 1,102,600 IU/ml, and 49% of patients had HCV genotype 1 (32% 1b), 28% genotype 2, 10% genotype 3 and 13% genotype 4. The median estimated glomerular filtration rate was 90.2 ml/min, platelet count 209x103/mm3 and albumin 4.3 g/dl. The SVR rates were 94% in intention-to-treat and 99.3% in per protocol analysis (8-week vs. 12 or 16-week: 99.2% vs. 100%). Five patients failed therapy because of post-treatment relapse; a post-treatment NS5A resistance-associated substitution was detected in 1 case. SVR rates were lower in males (p = 0.002) and in HCV genotype-3 (p = 0.046) patients treated for 8 weeks, but independent of treatment duration, fibrosis stage, baseline HCV-RNA, HIV co-infection, chronic kidney disease stage and viral kinetics. Mild adverse events were reported in 8.3% of the patients, and 0.7% of them prematurely withdrew treatment. Three patients died of drug-unrelated causes.
In a large real-world cohort of Italian patients, we confirmed the excellent effectiveness and safety of G/P administered for 8, 12 or 16 weeks.
A large number of patients with hepatitis C virus have been treated with glecaprevir/pibrentasvir (G/P) within the NAVIGATORE-Lombardia Network, in Italy. This is the first real-world study evaluating effectiveness and safety of G/P in patients with hepatitis C virus treated according to international recommendations. This study demonstrated excellent effectiveness (with sustained virological response rates of 99.3%) and safety profiles.
In 207 cirrhotic patient carriers of hepatocellular carcinoma (HCC), percutaneous ethanol injection (PEI) was administered with ultrasound guidance. The patients were classified as Child's Class A, ...136; B, 54; and C, 17. Their mean age was 63.5 years, and the male‐female ratio was 3.5:1. There was a single HCC less than 5 cm in diameter in 162 patients; 45 had more than one HCC. The follow‐up ranged from 5 to 71 months (mean, 25 months). No noteworthy complications occurred during or after 2485 treatments. The 1‐year, 2‐year, and 3‐year survival percentages (by the Kaplan‐Meier method) for the patients with one HCC were 90%, 80%, and 63%, respectively. The corresponding percentages by Child's class were 97%, 92%, and 76% for Class A; 88%, 68%, and 42% for B; and 40%, 0%, and 0% for C. The 1‐year, 2‐year, and 3‐year survival rates for patients with more than one HCC were 90%, 67%, and 31%, respectively. These results were similar to those found by others and showed that PEI was a safe, reproducible, easy‐to‐do, and low‐cost therapeutic technique. In terms of survival, these PEI results were better than the published results of no treatment and equivalent to those of surgery. In uncontrolled series, bias can play an important role. Therefore, additional trials would be useful. Cancer 1992; 69: 925–929.
Abstract Purpose To compare the accuracy of immediate CEUS with results of 24-h CEUS and MDCT in early evaluation of liver tumors following thermal ablation, using the combined results of a 3 month ...follow-up MDCT and CEUS as a reference standard. Subjects and methods From our database, we selected patients who underwent a thermal ablation immediately followed by CEUS (within 5–10 min) between February 2009 and February 2011. There were 92 patients (median age 73 years), two of whom had repeat ablation during the study period for a total of 94 tumors. Sixty tumors were treated with radiofrequency and 34 with microwave ablation. All patients underwent CEUS and CT examinations at 24 h. For patients with more than one treated tumor in the same session, the lesion imaged post-procedural and at 24-h with CEUS in all vascular phases was selected. All measurements of the necrotic zone, as an avascular zone, were performed during the portal-venous phase. Immediate post-procedural CEUS and 24 h CEUS and MDCT were blindly reviewed by two radiologists. One radiologist blindly reviewed the follow-up imaging. The mean diameters of the necrotic zone at post-procedural CEUS, and CEUS and MDCT at 24 h were compared and diagnostic accuracy to detect residual tumor calculated for each index tests compared to 3-months follow-up imaging. Results The mean diameter of the necrotic zone was: 29 ± 9 mm at post-procedural CEUS, 34 ± 10 mm at 24 h CEUS and 35 ± 11 mm at 24 h MDCT. Mean diameter of the necrotic zone was significantly smaller at post-procedural CEUS compared to either CEUS or MDCT at 24 h ( p < 0.001 for all). With a 95% confidence interval, the sensitivity was 25% (11–47%) for immediate CEUS, 20% (8–42%) for CEUS at 24-h, and 40% (22–61%) for CT at 24-h. Specificity was 96% (89–99%) for immediate CEUS, 97% (91–99%) for CEUS at 24-h, and 97% (91–99%) for CT at 24-h. Conclusions Diagnostic accuracy of post-procedural CEUS in early evaluation of liver tumors following thermal ablation is comparable to both CEUS and MDCT performed at 24 h. Therefore, post-procedural CEUS can be used to detect and retreat residual viable tissue in the same ablation session.
To study local therapeutic efficacy, side effects, and complications of radio-frequency (RF) ablation in the treatment of medium and large hepatocellular carcinoma (HCC) lesions in patients with ...cirrhosis or chronic hepatitis.
One-hundred fourteen patients who were under conscious sedation or general anesthesia had 126 HCCs greater than 3.0 cm in diameter treated with RF by using an internally cooled electrode. Eighty tumors were medium (3.1-5.0 cm), and 46 were large (5.1-9.5 cm). The mean diameter for all tumors was 5.4 cm. At imaging, 75 tumors were considered noninfiltrating, and 51 were considered infiltrating.
Complete necrosis was attained in 60 lesions (47.6%), nearly complete (90%-99%) necrosis in 40 lesions (31.7%), and partial (50%-89%) necrosis in the remaining 26 lesions (20.6%). Medium and/or noninfiltrating tumors were treated successfully significantly more often than large and/or infiltrating tumors. Two major complications (death, hemorrhage requiring laparotomy) and five minor complications (self-limited hemorrhage, persistent pain) were observed. The single death was due to a break in sterile technique rather than to the RF procedure itself.
RF ablation appears to be an effective, safe, and relatively simple procedure for the treatment of medium and large HCCs.
The purpose of this study was to assess, with contrast-enhanced CT or MRI as the reference imaging technique, the diagnostic performance of low-mechanical-index contrast-enhanced sonography in ...detecting local tumor progression after percutaneous radiofrequency ablation of renal tumors.
Twenty-nine patients with 30 renal tumors (18 men, 11 women; mean age, 73 years; range, 53-83 years) underwent percutaneous radiofrequency ablation at a single center between March 1998 and January 2007. The imaging follow-up schedule was both contrast-enhanced sonography and CT or MRI 4 months after completion of treatment and every 4 months for the first year. Thereafter, the follow-up schedule was contrast-enhanced sonography every 4 months with CT or MRI every 8 months. The chi-square test with Yates correction was used to evaluate positive and negative predictive values and accuracy.
One patient was scheduled to undergo surgical resection, and another patient was lost to follow-up. Twenty-seven patients with 28 renal tumors participated in follow-up. The concordance between contrast-enhanced sonographic and CT or MRI findings was 100% for 27 of 28 tumors (96.4%) that had a hypervascular pattern before treatment. In the case of the tumor that was hypovascular at imaging performed before percutaneous radiofrequency ablation, local tumor progression was missed at contrast-enhanced sonography. The sensitivity, specificity, positive predictive value, negative predictive value, and overall accuracy of contrast-enhanced sonography were 96.6%, 100%, 100%, 95.8%, and 98.1%.
Contrast-enhanced sonography is an effective alternative to CT and MRI in the follow-up of renal tumors managed with percutaneous radiofrequency ablation.
Background & Aims
In the direct‐acting antiviral era, treatment of genotype‐3 HCV (HCV‐GT3) is still challenging. Real‐life comparisons between recommended regimens, sofosbuvir (SOF)+daclatasvir ...(DAC), SOF/velpatasvir (VEL), glecaprevir/pibrentasvir (GLE/PIB), are scarce. We aimed at filling this data gap.
Methods
Sustained virological response 12 weeks after treatment completion (SVR12) was assessed for all HCV‐GT3 patients consecutively treated within the Lombardia web‐based Navigatore HCV‐Network; differences in SVR12 across regimens were evaluated by logistic regression.
Results
Of the 2082 subjects with HCV‐GT3, 1544 were evaluable for comparisons between regimens: SOF + DAC (1023, 66.2%), SOF/VEL (369, 23.9%), GLE/PIB (152, 9.8%). Patients treated with former regimens were more frequently male, cirrhotic, HIV‐positive, pretreated, used ribavirin in their regimen, and had lower baseline HCV‐RNA. SVR12 was similar across groups: 94.8% in SOF + DAC, 97.6% in SOF/VEL, 96.7% in GLE/PIB (P = .065). At univariate analysis, SVR12 was associated with female gender (97.9% vs 94.8%, P = .007) and lower median pretreatment Log10HCV‐RNA (5.87 vs 6.20, P = .001). At multivariate logistic regression analysis, treatment with SOF/VEL was associated with a higher likelihood of SVR12 than SOF + DAC, but only in the absence of ribavirin (98% vs 90.3%). Female gender and lower pretreatment HCV‐RNA were independently associated with SVR12.
Conclusions
In a large real‐life setting of HCV‐GT3‐infected patients with a high proportion of cirrhosis, the success rate was remarkable. The slight advantage of SOF/VEL on SOF + DAC was significant only without ribavirin. The current prescription shift towards novel regimens (ie SOF/VEL and GLE/PIB) in easier‐to‐treat patients allows ribavirin‐free and shorter schedules without mining SVR12 in this <<difficult‐to‐treat>> genotype.
Sofosbuvir (SOF)-based regimens have been associated with renal function worsening in HCV patients with estimated glomerular filtration rate (eGFR) ≤ 45 ml/min, but further investigations are ...lacking.
To assess renal safety in a large cohort of DAA-treated HCV patients with any chronic kidney disease (CKD).
All HCV patients treated with DAA in Lombardy (December 2014–November 2017) with available kidney function tests during and off-treatment were included.
Among 3264 patients 65% males, 67% cirrhotics, eGFR 88 (9–264) ml/min, CKD stage was 3 in 9.5% and 4/5 in 0.7%. 79% and 73% patients received SOF and RBV, respectively. During DAA, eGFR declined in CKD-1 (p < 0.0001) and CKD-2 (p = 0.0002) patients, with corresponding rates of CKD stage reduction of 25% and 8%. Conversely, eGFR improved in lower CKD stages (p < 0.0001 in CKD-3a, p = 0.0007 in CKD-3b, p = 0.024 in CKD-4/5), with 33–45% rates of CKD improvement. Changes in eGFR and CKD distribution persisted at SVR. Baseline independent predictors of CKD worsening at EOT and SVR were age (p < 0.0001), higher baseline CKD stages (p < 0.0001) and AH (p = 0.010 and p < 0.0001, respectively).
During DAA, eGFR significantly declined in patients with preserved renal function and improved in those with lower CKD stages, without reverting upon drug discontinuation.
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