Development and Validation of a New Prognostic System for Patients with Hepatocellular Carcinoma

BACKGROUND: Prognostic assessment in patients with hepatocellular carcinoma (HCC) remains controversial. Using the Italian Liver Cancer (ITA.LI.CA) database as a training set, we sought to develop and validate a new prognostic system for patients with HCC. METHODS AND FINDINGS: Prospective collected databases from Italy (training cohort, n = 3,628; internal validation cohort, n = 1,555) and Taiwan (external validation cohort, n = 2,651) were used to develop the ITA.LI.CA prognostic system. We first defined ITA.LI.CA stages (0, A, B1, B2, B3, C) using only tumor characteristics (largest tumor diameter, number of nodules, intra- and extrahepatic macroscopic vascular invasion, extrahepatic metastases). A parametric multivariable survival model was then used to calculate the relative prognostic value of ITA.LI.CA tumor stage, Eastern Cooperative Oncology Group (ECOG) performance status, Child-Pugh score (CPS), and alpha-fetoprotein (AFP) in predicting individual survival. Based on the model results, an ITA.LI.CA integrated prognostic score (from 0 to 13 points) was constructed, and its prognostic power compared with that of other integrated systems (BCLC, HKLC, MESIAH, CLIP, JIS). Median follow-up was 58 mo for Italian patients (interquartile range, 26-106 mo) and 39 mo for Taiwanese patients (interquartile range, 12-61 mo). The ITA.LI.CA integrated prognostic score showed optimal discrimination and calibration abilities in Italian patients. Observed median survival in the training and internal validation sets was 57 and 61 mo, respectively, in quartile 1 (ITA.LI.CA score 64 1), 43 and 38 mo in quartile 2 (ITA.LI.CA score 2-3), 23 and 23 mo in quartile 3 (ITA.LI.CA score 4-5), and 9 and 8 mo in quartile 4 (ITA.LI.CA score > 5). Observed and predicted median survival in the training and internal validation sets largely coincided. Although observed and predicted survival estimations were significantly lower (log-rank test, p < 0.001) in Italian than in Taiwanese patients, the ITA.LI.CA score maintained very high discrimination and calibration features also in the external validation cohort. The concordance index (C index) of the ITA.LI.CA score in the internal and external validation cohorts was 0.71 and 0.78, respectively. The ITA.LI.CA score's prognostic ability was significantly better (p < 0.001) than that of BCLC stage (respective C indexes of 0.64 and 0.73), CLIP score (0.68 and 0.75), JIS stage (0.67 and 0.70), MESIAH score (0.69 and 0.77), and HKLC stage (0.68 and 0.75). The main limitations of this study are its retrospective nature and the intrinsically significant differences between the Taiwanese and Italian groups. CONCLUSIONS: The ITA.LI.CA prognostic system includes both a tumor staging-stratifying patients with HCC into six main stages (0, A, B1, B2, B3, and C)-and a prognostic score-integrating ITA.LI.CA tumor staging, CPS, ECOG performance status, and AFP. The ITA.LI.CA prognostic system shows a strong ability to predict individual survival in European and Asian populations

Six-month outcomes from a randomized controlled trial of minimally invasive SI joint fusion with triangular titanium implants vs conservative management

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Years of life that could be saved from prevention of hepatocellular carcinoma

BACKGROUND: Hepatocellular carcinoma (HCC) causes premature death and loss of life expectancy worldwide. Its primary and secondary prevention can result in a significant number of years of life saved. AIM: To assess how many years of life are lost after HCC diagnosis. METHODS: Data from 5346 patients with first HCC diagnosis were used to estimate lifespan and number of years of life lost after tumour onset, using a semi-parametric extrapolation having as reference an age-, sex- and year-of-onset-matched population derived from national life tables. RESULTS: Between 1986 and 2014, HCC lead to an average of 11.5 years-of-life lost for each patient. The youngest age-quartile group (18-61 years) had the highest number of years-of-life lost, representing approximately 41% of the overall benefit obtainable from prevention. Advancements in HCC management have progressively reduced the number of years-of-life lost from 12.6 years in 1986-1999, to 10.7 in 2000-2006 and 7.4 years in 2007-2014. Currently, an HCC diagnosis when a single tumour <2 cm results in 3.7 years-of-life lost while the diagnosis when a single tumour 65 2 cm or 2/3 nodules still within the Milan criteria, results in 5.0 years-of-life lost, representing the loss of only approximately 5.5% and 7.2%, respectively, of the entire lifespan from birth. CONCLUSIONS: Hepatocellular carcinoma occurrence results in the loss of a considerable number of years-of-life, especially for younger patients. In recent years, the increased possibility of effectively treating this tumour has improved life expectancy, thus reducing years-of-life lost

Correlation Between Sagittal Balance and Mechanical Distal Junctional Failure in Degenerative Pathology of the Spine: A Retrospective Analysis

Study design Retrospective cohort study. Objectives This study aimed to investigate the failure of the caudal end of lumbar posterior fixation in terms of pre-operative and post-operative spinopelvic parameters, correction performed, demographic and clinical data. Methods The lumbar, thoraco-lumbar and lumbo-sacral posterior fixations performed with pedicle screws and rods in 2017-2019 were retrospectively analyzed. As 81% failures occurred within 4 years, an observational period of 4 years was chosen. The revision surgeries due to the failure in the caudal end were collected in the junctional group. Fixations which have not failed were gathered in the control group. The main spinopelvic parameters were measured for each patient on standing lateral radiographs with the software Surgimap. Demographic and clinical data were extracted for both groups. Results Among the 457 patients who met the inclusion criteria, the junctional group included 101 patients, who required a revision surgery. The control group collected 356 primary fixations. The two most common causes of revision surgeries were screws pullout (57 cases) and rod breakage (53 cases). SVA, PT, LL, PI-LL and TPA differed significantly between the two groups (P = .021 for LL, P &lt; .0001 for all the others). The interaction between the two groups and the pre-operative and post-operative conditions was significant for PT, SS, LL, TK, PI-LL and TPA (P &lt; .005). Sex and BMI did not affect the failure onset. Conclusions Mechanical failure is more likely to occur in patients older than 40 years with a thoraco-lumbar fixation where PT, PI-LL and TPA were not properly restored

Primary vascular bone tumors in the spine: a challenge for pathologists and spine oncology surgeons

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Minimally Invasive Posterior Stabilization Improved Ambulation and Pain Scores in Patients with Plasmacytomas and/or Metastases of the Spine

Background. The incidence of spine metastasis is expected to increase as the population ages, and so is the number of palliative spinal procedures. Minimally invasive procedures are attractive options in that they offer the theoretical advantage of less morbidity. Purpose. The purpose of our study was to evaluate whether minimally invasive posterior spinal instrumentation provided significant pain relief and improved function. Study Design. We compared pre- and postoperative pain scores as well as ambulatory status in a population of patients suffering from oncologic conditions in the spine. Patient Sample. A consecutive series of patients with spine tumors treated minimally invasively with stabilization were reviewed. Outcome Measures. Visual analog pain scale as well as pre- and postoperative ambulatory status were used as outcome measures. Methods. Twenty-four patients who underwent minimally invasive posterior spinal instrumentation for metastasis were retrospectively reviewed. Results. Seven (29%) patients were unable to ambulate secondary to pain and instability prior to surgery. All patients were ambulating within 2 to 3 days after having surgery (P = 0.01). The mean visual analog scale value for the preoperative patients was 2.8, and the mean postoperative value was 1.0 (P = 0.001). Conclusion. Minimally invasive posterior spinal instrumentation significantly improved pain and ambulatory status in this series

The Vertebral Bone Marrow clot as cell therapy and multifunctional bioscaffold for spinal fusion surgery: protocol for a randomized clinical trial

IntroductionSpinal fusion (SF) represents a commonly performed orthopedic surgical procedure, and to enhance its success rate, various adjunctive therapies have been explored, including the application of local autografts, bone allografts, and different formulations of Bone Marrow Aspirate (BMA). Among these, Vertebral Bone Marrow Aspirate (vBMA) clot emerges as an innovative and promising avenue for future development. The primary challenge in using vBMA clot for SF procedures lies in the lack of high-level clinical evidence demonstrating whether its combination with bone allograft chips is superior to using bone allograft chips alone. Additionally, there is a shortage of preclinical studies investigating the intrinsic biological, anti-inflammatory, and antibacterial properties of vBMA clots.Methods and analysisPatients with degenerative lumbar spine diseases (aged 18–80 years, with ≤5 levels involved) are randomly assigned in a 1:1 ratio to undergo SF with autologous vBMA clot associated with bone allograft chips or bone allograft chips alone by a blinded experimenter, who is not involved in the RCT. The primary aim is to evaluate the SF rate and time in the two groups as well as consider age and gender differences. SF rate and time are evaluated with CT scans and x-rays and performed preoperatively and at 1, 3, 6, and 12 months of follow-up (FU). Using the Brantigan classification, quantitative CT analyses of facet joint space density are calculated at baseline and in follow-up controls to complement the standard qualitative visual scale. CT and X-rays will be assessed in a blinded manner by a diagnostic and interventional radiologist. The secondary outcome is to evaluate the pseudoarthrosis rate estimated using the Brantigan classification, and the clinical outcomes are assessed using the Visual Analog Scale (VAS), the Oswestry Disability Index (ODI), and the Short Form 36 Health Survey (SF-36) questionnaire by comparing baseline (pre-surgery) values with those at 1, 3, 6, and 12 months of FUs. All scores and the questionnaire will be evaluated by a blinded assessor. Complications are also recorded and classified as early (major and minor) or late, according to the time of occurrence and findings at 12 months post-surgery. Finally, the preclinical project outcome is to define the biological and anti-inflammatory properties of vBMA clot and demonstrate its antibacterial effect, assessing age and gender differences and including an examination of their interactions.Clinical trial registrationClinicalTrials.gov, identifier NCT05947175