BACKGROUND AND AIMS:The benefit of long-term albumin (LTA) in improving survival and reducing complications in patients with cirrhosis and ascites is not consistently observed across studies, possibly reflecting differences in patient populations and treatment regimens. This study aimed to determine whether baseline serum albumin (SA) levels can predict which patients are most likely to benefit from LTA therapy. METHODS:A post hoc analysis of the ANSWER trial was performed in 431 patients randomized to receive standard medical treatment (SMT) alone or SMT plus human albumin (SMT + HA). The interaction between baseline SA and LTA was investigated using competing-risk survival analysis. The primary endpoint was 18-month survival. Secondary endpoints included the incidence of cirrhosis-related complications and hospitalizations. RESULTS:A significant treatment-by-albumin non-linear interaction was found (p = 0.010), indicating heterogeneity of treatment effect across baseline SA levels with the upper bound of the region of statistically demonstrable benefit occurring at approximately 3.2 g/dL (sHR 0.53, 95% CI 0.28-0.99). In patients with SA ≤ 3.2 g/dL, 18-month survival was significantly higher in the SMT + HA group compared with SMT alone (HR 0.47, 95% CI 0.29-0.77; p = 0.0021). No significant survival difference could be demonstrated in patients with SA > 3.2 g/dL (HR 1.04, 95% CI 0.41-2.63; p = 0.93). Regardless of baseline SA levels, LTA was associated with improved ascites control and reduced rates of complications and hospitalizations. CONCLUSIONS:LTA provides survival and morbidity benefits in patients with mild-to-moderate hypoalbuminemia, whereas in patients with normal SA levels, its benefit appears mainly limited to morbidity reduction. Baseline SA may therefore help in prioritizing LTA therapy when resources are constrained.
Background and Aims: Preliminary results from the PRECIOSA trial (AASLD congress 2025) suggested that patients with normal serum albumin (SA) concentrations may not have a survival benefit from long-term albumin (LTA). We investigated whether baseline SA influences survival and other clinical outcomes in patients receiving LTA.Methods: This is a post-hoc analysis of the ANSWER randomized clinical trial including 431 patients with cirrhosis and uncomplicated grade 2 or 3 ascites randomized to receive standard medical treatment (SMT) alone or SMT + human albumin (HA) (40 g twice weekly for two weeks, then 40 g weekly) for up to 18 months. To identify the most discriminatory baseline SA threshold, candidate cut-offs between 2.5 and 4.2 g/dL (0.1 g/dL increments) were tested. For each value, 18-month survival was compared between treatment arms using the log-rank test, and the cut-off with the lowest p value was selected. The primary endpoint was 18-month survival; secondary endpoints included the incidence rates (IR) of cirrhosis-related complications. Comparisons were conducted within subgroups stratified by baseline SA concentration.Results: At baseline, patients randomized to the two arms did not differ in SA concentration (SMT 3.1±0.5 vs. SMT+HA 3.1±0.6 g/dL, p=0.86). The baseline SA cut-off associated with the greatest survival benefit was 3.2 g/dL. Overall, 275 patients (64%) had baseline SA ≤3.2 g/dL (132 SMT, 143 SMT+HA). The 18-month survival was significantly higher in SMT+HA than SMT in patients with baseline SA ≤3.2 g/dL (HR 0.47, 95%CI 0.29-0.77, p=0.002), while it was similar in patients with SA >3.2 g/dL (HR 1.04, 95%CI 0.41-2.63, p=0.93). In contrast, the cumulative incidence of paracentesis was lower in the SMT+HA group compared to SMT either in patients with SA ≤3.2 g/dL (HR 0.45 95% CI 0.31-0.65, p<0.001) and in those with SA >3.2 g/dL (HR 0.52 95% CI 0.32-0.87, p=0.010). Similarly, the reduction of complications (i.e., spontaneous bacterial peritonitis, non-SBP infections, grade III/IV hepatic encephalopathy) observed in patients receiving LTA was similar in those presenting at baseline either SA ≤3.2 g/dL or SA >3.2 g/dL).Conclusion: Baseline SA concentration can be used to identify those patients with uncomplicated grade 2-3 ascites who receive the greatest survival benefit from LTA, while the advantage associated with LTA in managing ascites and other complications appears to be independent of baseline SA. This finding suggests that patients with at least mild to moderate hypoalbuminemia are the best candidates to receive LTA and could be prioritized in healthcare settings with limited resources.
Background: To evaluate whether quantitative signal intensity (SI) measured on the hepatobiliary phase (HBP) of gadoxetic-acid-enhanced MRI is associated with disease control rate (DCR) after conventional transarterial chemoembolization (cTACE) in patients with hepatocellular carcinoma (HCC). Methods: In this retrospective single-center study, 112 patients with HCC treated with cTACE between April 2018 and September 2020 and with available pre-treatment gadoxetic acid-enhanced MRI were included, with one target HCC lesion analyzed per patient. Mean HBP SI was quantitatively measured using manually drawn regions of interest (ROIs) within the target tumor, adjacent liver parenchyma, and reference tissues. Treatment response was assessed using mRECIST criteria at 1, 3, and 6 months. Logistic regression and receiver operating characteristic analyses were performed to evaluate the association between HBP SI and DCR. Results: Lower tumor HBP SI was associated with DCR at 6 months after cTACE (unadjusted p = 0.010; Bonferroni-adjusted p = 0.030), whereas no significant association was observed at 1 or 3 months. A tumor HBP SI cut-off value of 580 demonstrated moderate discriminatory performance for DCR (AUC = 0.714, 95% CI: 0.585–0.843; p = 0.008), with 69.1% sensitivity and 80.0% specificity. Conclusions: Lower baseline tumor HBP SI was associated with 6-month radiological disease control after cTACE in this exploratory single-center cohort. However, its moderate discriminatory performance, the absence of significant associations at earlier response assessments, and the methodological limitations of the study preclude its use as a stand-alone clinical decision-making tool. HBP SI should therefore be regarded as a potential imaging biomarker, and these findings should be considered hypothesis-generating and require validation in larger, independent cohorts.
Background and aims: Sarcopenia has been associated with poor outcomes in patients with cirrhosis and hepatocellular carcinoma. We investigated the impact of sarcopenia on survival in patients with advanced hepatocellular carcinoma treated with Sorafenib. Methods: A total of 328 patients were retrospectively analyzed. All patients had an abdominal CT scan within 8 weeks prior to the start of treatment. Two cohorts of patients were analyzed: the “Training Group” (215 patients) and the “Validation Group” (113 patients). Sarcopenia was defined by reduced skeletal muscle index, calculated from an L3 section CT image. Results: Sarcopenia was present in 48% of the training group and 50% of the validation group. At multivariate analysis, sarcopenia (HR: 1.47, p = 0.026 in training; HR 1.99, p = 0.033 in validation) and MELD > 9 (HR: 1.37, p = 0.037 in training; HR 1.78, p = 0.035 in validation) emerged as independent prognostic factors in both groups. We assembled a prognostic indicator named “SARCO-MELD” based on the two independent prognostic factors, creating three groups: group 1 (0 prognostic factors), group 2 (1 factor) and group 3 (2 factors), the latter with significantly worse survival and shorter time receiving treatment.
The aim of the present study was to test a new oral contrast medium composed of natural components for the magnetic resonance (MR) imaging of small bowel diseases. Between January 2018 and June 2019, 35 patients affected by ileocolic Crohn's disease (CD) were enrolled in the present study. Each patient underwent two sequential MR enterographies, first with the standard polyethylene glycol (PEG) water solution and, after 3 weeks, with the new natural beverage designed by our team. At the end of the administration of each oral contrast, a satisfaction survey was given to the patients to assess the palatability of both beverages. The intestinal distention and the quality of images were evaluated by two expert radiologists for both studies and the interreader agreement was calculated. According to the satisfaction questionnaire, 97.1% of patients expressed positive judgments regarding the natural beverage (71.4% very good and 25.7% good) whereas only 8.6% of them appreciated the PEG water solution (8.6% good) (p = 0.0001). The degree of intestinal distention was excellent and good in 97.1% of patients after the administration of PEG and in 94.3% of the patients after the administration of the natural beverage, without significant differences between the two products and with almost perfect (k = 0.821) and substantial (k = 0.754) inter-observer variability, respectively. No statistical differences were observed between the two expert radiologists regarding the evaluation of the imaging quality; in particular, they were considered good and excellent in 100% of patients after the administration of PEG water solution and in 97.2% of those who took the natural beverage, with substantial (k = 0.618) and almost perfect (k = 0.858) inter-observer variability, respectively. The new natural beverage demonstrated the same intestinal distension and excellent image quality compared to the synthetic standard oral contrast administered during MRE for small bowel diseases, proving to be a valid alternative with better palatability.
Esophagogastroduodenoscopy (EGD) appropriateness in Open-Access System (OAS) is a relevant issue. The Gastropack Access System (GAS) is a new system to access gastroenterological services, based on the partnership between Gastroenterologists and GPs. This study aims to evaluate if GAS is superior to OAS in terms of EGDS appropriateness. Secondarily, we evaluated the diagnostic yield of EGDS according to ASGE guidelines. The GAS was developed in an area of Bologna where General Practitioners (GPs) could decide to directly prescribe EGDS through OAS or referring to GAS, where EGDS can be scheduled after contact between GPs and specialists sharing a patient’s clinical information. Between 2016 and 2019, 2179 cases (M:F = 861:1318, median age 61, IQR 47.72) were referred to GAS and 1467 patients (65%) had a prescription for EGDS; conversely, 874 EGDS were prescribed through OAS (M:F = 383:491; median age 58 yrs, IQR 45.68). Indication was appropriate in 92% in GAS (1312/1424) versus 71% in OAS (618/874), p < 0.001. The rate of clinically significant endoscopic findings (CSEF) was significantly higher in GAS (49% vs. 34.8%, p < 0.001). Adherence to ASGE guidelines was not related to CSEF; however, surveillance for pre-malignant conditions was independently related to CSEF. All neoplasm were observed in appropriate EGD. GAS is an innovative method showing extremely high rates of appropriateness. ASGE guidelines confirmed their validity for cancer detection, but their performance for the detection of other conditions needs to be refined.
To evaluate the potential variability of Manganese (Mn 2+ ) in commercial pineapple juice (PJ) produced in different years and to identify the optimal Mn 2+ concentration in the correct amount of PJ to be administered prior to Magnetic Resonance Cholangiopancreatography (MRCP) in order to suppress the gastroduodenal (GD) liquid signal. The Mn 2+ concentration in PJ produced in different years was defined using Atomic Absorption Spectrometry. The optimal Mn 2+ concentration and the amount of PJ, were estimated in an in-vitro analysis, and were then prospectively tested in a population of patients who underwent MRCP. The results were compared with those achieved with the previous standard amount of PJ used in a similar population. The concentrations of Mn 2+ in commercial PJ produced in different years did not differ. A total amount of 150 ml (one glass) of PJ having a high Mn 2+ content (2.37 mg/dl) was sufficient for the suppression of the GD liquid signal, despite the additional dilution caused by GD liquids since it led to a final concentration of Mn 2+ of 0.5–1.00 mg/dl. The optimized single-dose oral administration of 150 ml (approximately one glass) of PJ having a high Mn 2+ concentration prior to MRCP was adequate to guarantee the correct amount of Mn 2+ to suppress the GD signal.
Introduction Sarcopenia, defined as reduced muscle mass and function, has been associated with poor outcomes in patients with cirrhosis and hepatocellular carcinoma (HCC).
The number of elderly patients diagnosed with hepatocellular carcinoma (HCC) is progressively increasing. The aim of this study was to determine the safety and efficacy of conventional transarterial chemoembolization (TACE) in elderly HCC patients compared with younger adults. A consecutive cohort of unresectable HCC patients treated with TACE as a first-line treatment was retrospectively analyzed. Patients were categorized into “elderly” (≥ 70 years, 80 patients) and “younger” (< 70 years, 145 patients). Liver-related death and progression-free survival after TACE were compared before and after propensity score matching. A competing risk regression analysis was used for univariate/multivariate survival data analysis. cTACE was well tolerated in both groups. The cumulative risk of both liver-related death and progression-free survival after cTACE was comparable between “elderly” and “younger” (death: 73.8% vs 69.4%, P = 0.505; progression-free survival: 48.2% vs 44.8%, P = 0.0668). Propensity model matched 61 patients in each group for gender and Barcelona Clinic Liver Cancer staging. Even after matching, the cumulative risk of liver-related death and of progression-free survival did not differ between the two groups. At multivariate analysis, Child–Pugh class, tumor gross pathology and alpha-fetoprotein were independently associated with the liver-related mortality risk. This study confirms that TACE is well tolerated and effective in patients aged 70 years or more with unresectable HCC as it is for their younger counterparts (< 70 years). Liver-related mortality was not associated with age ≥ 70 years and primarily predicted by tumor multifocality, Child–Pugh class B and an increased alpha-fetoprotein value (> 31 ng/ml).
Background. Bacterial and fungal infections (BFIs) are frequent in patients with cirrhosis and often trigger acute-on-chronic liver failure (ACLF). This prospective observational study aims to describe the interactions between BFI and ACLF in terms of mortality and related risk factors. Methods. We performed a 2-center prospective observational study enrolling hospitalized patients with cirrhosis admitted for acute decompensation. Data were recorded at admission and during hospitalization. Survival was recorded up to 1 year. Results. Among the 516 patients enrolled, 108 (21%) were infected at admission, while an additional 61 patients (12%) developed an infection during hospital stay. In the absence of ACLF, the 1-year mortality rate of patients with BFI did not differ from that of patients without BFI (33% vs 31%; P = .553). In contrast, those with ACLF triggered or complicated by BFI had a significantly higher mortality rate than those who remained free from BFI (75% vs 54%; P = .011). Competing risk analysis showed that the negative impact of ACLF-related BFI on long-term prognosis was independent from Model for End-stage Liver Disease (MELD) incorporating serum sodium concentration score, comorbidity, and basal C-reactive protein level. Finally, multivariable logistic regression showed that higher MELD score (P < .001), QuickSOFA score >= 2 points (P = .007), and secondary bloodstream (P = .022) and multidrug-resistant pathogen isolation (P = .030) were independently associated with ACLF in patients with BFI. Conclusions. This large prospective study indicated that the adverse impact of BFI on long-term survival in decompensated cirrhosis is not universal but is limited to those patients who also develop ACLF. Both disease severity and microbiological factors predispose infected decompensated patients to ACLF.
We aimed to evaluate whether pelvic magnetic resonance imaging (MRI) could play a role in better assessing chronic pelvic pain syndrome. We evaluated 44 male patients (median 41 aged) with a clinical history of painful pelvic symptoms, lasting for at least three of the previous 6 months, associated with urinary, anorectal and sexual disorders in the absence of bacterial prostate infection. All these patients underwent ultrasound (US) and MRI evaluation of the pelvis. Prostate imaging findings, such as gland morphology evaluated by US and prostatic signal intensity on MRI, appeared normal in the majority of patients (38/44; 82%). Extraparenchymal alterations were found in 28 patients (63.6%); the most frequent was the dilatation of periprostatic vein plexus (20/28; 71.4%), significantly correlated to chronic pelvic pain syndrome (p = 0.0013), regardless of different clinical presentations. This finding was tested in a control group of 90 patients, demonstrating an excellent specificity (97%), good positive predictive value (87%) and diagnostic accuracy (80%). MRI confirmed its high capability in evaluating prostatic and extraprostatic structures. Periprostatic vein dilatation, which identified approximately two-thirds of the patients with chronic pelvic pain syndrome using pelvic MRI, significantly correlated to chronic pelvic pain syndrome, independently of patient age, symptoms and prostatic volume.
We were very interested to read the study recently published in Gastroenterology by Moon et al . (1). Performed as a case-control study within the US Veterans Affairs health care system, the study aimed to assess the association between screening for hepatocellular carcinoma (HCC) and cancer related-mortality in patients with cirrhosis. The authors did not find any evidence that screening patients with cirrhosis by abdominal ultrasound (US) or alpha-fetoprotein (AFP) levels decreases HCC-related mortality.
OBJECTIVES:This study investigates the diagnostic performance of a new T1 imaging series, generated by the digital subtraction of the opposed phase from in phase T 1 weighted images, in MRI for renal angiomyolipoma (AML) evaluation.METHODS:This retrospective study involved 96 patients, 63 (65.6%) with at least one renal AML and 33 (34.4%) healthy patients. Two radiologists having different experience retrospectively reviewed two MR imaging series, starting with in and out-phase T 1 weighted images and then the new subtracted T1 images, in which AML appeared white on black background. The presence, number, location, and dimensions of the AMLs, and reading time were collected separately for the two kidneys. Statistical analysis was carried out using the appropriate tests.RESULTS:The number of lesions identified and the evaluation of lesion dimension did not statistically differ between the different MR imaging series evaluated, without interobserver variability. Both percentage agreement of the total number of observations and the κ coefficient showed very good agreement between the radiologists. The median time for the diagnosis was statistically lower when using the subtracted T1 imaging series for both observers with a median gain from 6.5 to 15 s per identified lesion, resulting in a total time-saving of more than half (52.9%), in both patients with and without AMLs, and in patients with a single or with more than one AML (p < 0.001).CONCLUSIONS:The new subtracted T1 imaging series proved to be reliable in identifying fat-containing renal lesions, by both expert and non-expert radiologists, resulting in a saving of both time and money. Moreover, this new subtracted T1 imaging series could be an effective tool in non-dedicated kidney examinations in which a faster reading is advisable.ADVANCES IN KNOWLEDGE:The opportunity of using a single set of MRI images in kidney evaluation for identifying fat-containing lesions, considerably reducing reading time, resulting in cost-effectiveness.
AIM: To identify, in vitro, the best fruit juice to use as oral contrast agent in magnetic resonance cholangiopancreatography (MRCP) and to test, in vivo, the best natural juice and the new parameters in MRCP sequences identified in vitro. MATERIALS AND METHODS: The in vitro evaluations consisted of measuring the T2 values of a pure solution of manganese (Mn) and iron (Fe) at different concentrations, measuring the content of Mn and Fe in five commercial juices and their T2 relaxation times, and identifying the optimal juice dilution for suppressing the gastrointestinal fluid signal. The new parameters of MRCP sequences were tested in vivo. RESULTS: Manganese alone strongly influenced the shortening of the T2 values (p=0.004). The T2 value with an echo time (TE) of >= 1,000 ms enabled sufficient intestinal fluid suppression in the case of high juice dilution. A flip angle of 90 degrees maximised the differences between the high signal from static fluids, such as the bile and the fluid in the gastrointestinal tract, using fast imaging employing steady-state acquisition (FIESTA) sequences (p<0.001). CONCLUSION: The shortening of the T2 relaxation time depended only on the Mn concentration. All the commercial juices had an Mn concentration sufficient to suppress the gastrointestinal fluid signal using long TE sequences. The oral ingestion of commercial juice before MRCP was enough to suppress the signal from the gastrointestinal fluids, regardless of its dilution after ingestion. When using FIESTA sequences, a flip angle of 90 degrees allowed the best suppression of gastrointestinal fluid signals. (C) 2018 The Royal College of Radiologists. Published by Elsevier Ltd. All rights reserved.
Objective Many improvements have been made in diagnosing hepatocellular carcinoma (HCC), but the radiological hallmarks of HCC have remained the same for many years. We prospectively evaluated the imaging criteria of HCC, early HCC and high-grade dysplastic nodules (HGDNs) in patients under surveillance for chronic liver disease, using gadolinium-ethoxybenzyl-diethylenetriamine pentaacetic acid (Gd-EOB-DTPA) MRI and diffusion-weighted imaging. Design Our study population included 420 nodules >1 cm in 228 patients. The MRI findings of each nodule were collected in all sequences/phases. The diagnosis of HCC was made according to the American Association for the Study of Liver Diseases (AASLD) criteria; all atypical nodules were diagnosed using histology. Results A classification and regression tree was developed using three MRI findings which were independently significant correlated variables for early HCC/HCC, and the best sequence of their application in a new diagnostic algorithm (hepatobiliary hypointensity, arterial hyperintensity and diffusion restriction) was suggested. This algorithm demonstrated, both in the entire study population and for nodules ≤2 cm, higher sensitivity (96% [95% CI 93.5% to 97.6%] and 96.6% [95% CI 93.9% to 98.5%], P<0.001, respectively) and slightly lower specificity (91.8% [95% CI 88.6% to 94.1%], P=0.063, and 92.7% [95% CI 88.9% to 95.4%], P=0.125, respectively) than those of the AASLD criteria. Our new diagnostic algorithm also showed a very high sensitivity (94.7%; 95% CI 92% to 96.6%) and specificity (99.3%; 95% CI 97.7% to 99.8%) in classifying HGDN. Conclusion Our new diagnostic algorithm demonstrated significantly higher sensitivity and comparable specificity than those of the AASLD imaging criteria for HCC in patients with cirrhosis evaluated using Gd-EOB-DTPA MRI, even for lesions ≤2 cm. Moreover, this diagnostic algorithm allowed evaluating other lesions which could arise in a cirrhotic liver, such as early HCC and HGDN.