Nanoliposomal Irinotecan With Fluorouracil and Leucovorin or Gemcitabine Plus Cisplatin in Advanced Cholangiocarcinoma: A Phase II Study of the AIO Hepatobiliary-YMO Cancer Groups (NIFE-AIO-YMO HEP-0315).

PURPOSE: First-line therapy options in advanced cholangiocarcinoma (CCA) are based on the ABC-02 trial regimen (gemcitabine/cisplatin [G/C]). The NIFE trial examined nanoliposomal irinotecan/fluorouracil/leucovorin (nal-IRI/FU/LV) as alternative first-line therapy in advanced CCA. METHODS: NIFE is a prospective, open-label, randomized, multicenter phase II study that aimed at detecting efficacy comparable with the standard treatment. Patients with advanced CCA were randomly assigned (1:1) to receive nal-IRI/FU/LV (arm A) or G/C (arm B). Stratification parameters were intrahepatic versus extrahepatic CCA, sex, and Eastern Cooperative Oncology Group (ECOG; 0/1). Arm A was designed as a Simon's optimal two-stage design and arm B served as a randomized control group. The primary goal was to exclude an inferior progression-free survival (PFS) at 4 months of only 40%, while assuming a rate of 60% on G/C population. RESULTS: Between 2018 and 2020, overall 91 patients were randomly assigned to receive nal-IRI/FU/LV (n = 49) or G/C (n = 42). The NIFE trial formally met its primary end point with a 4-month PFS rate of 51% in patients receiving nal-IRI/FU/LV. The median PFS was 6 months (2.4-9.6) in arm A and 6.9 months (2.5-7.9) in arm B. Median overall survival (OS) was 15.9 months (10.6-20.3) in arm A and 13.6 months (6.5-17.7) in arm B. The exploratory comparison of study arms suggested a numerical but statistically not significant advantage for nal-IRI/FU/LV (hazard ratio for PFS, 0.85 [95% CI, 0.53 to 1.38] and for OS, 0.94 [95% CI, 0.58 to 1.50]). Analysis for stratification parameters revealed no differences for sex and ECOG, but for tumor localization. The objective response rate was 24.5% with nal-IRI/FU/LV and 11.9% with G/C. No unexpected toxicities occurred. AEs related to nal-IRI/FU/LV were mainly GI and to G/C hematologic. CONCLUSION: Treatment of advanced CCA with nal-IRI/FU/LV demonstrated efficacy in first-line therapy without new safety findings and merits further validation.

Opportunistic screening for long-term muscle wasting in critically ill patients: insights from an acute pancreatitis cohort.

OBJECTIVES: To assess the feasibility of long-term muscle monitoring, we implemented an AI-guided segmentation approach on clinically indicated Computed Tomography (CT) examinations conducted throughout the hospitalization period of patients admitted to the intensive care unit (ICU) with acute pancreatitis (AP). In addition, we aimed to investigate the potential of muscle monitoring for early detection of patients at nutritional risk and those experiencing adverse outcomes. This cohort served as a model for potential integration into clinical practice. MATERIALS: Retrospective cohort study including 100 patients suffering from AP that underwent a minimum of three CT scans during hospitalization, totaling 749 assessments. Sequential segmentation of psoas muscle area (PMA) was performed and was relative muscle loss per day for the entire monitoring period, as well as for the interval between each consecutive scan was calculated. Subgroup and outcome analyses were performed including ANOVA. Discriminatory power of muscle decay rates was evaluated using ROC analysis. RESULTS: Monitoring PMA decay revealed significant long-term losses of 48.20% throughout the hospitalization period, with an average daily decline of 0.98%. Loss rates diverged significantly between survival groups, with 1.34% PMA decay per day among non-survivors vs. 0.74% in survivors. Overweight patients exhibited significantly higher total PMA losses (52.53 vs. 42.91%; p = 0.02) and average PMA loss per day (of 1.13 vs. 0.80%; p = 0.039). The first and the maximum decay rate, in average available after 6.16 and 17.03 days after ICU admission, showed convincing discriminatory power for survival in ROC analysis (AUC 0.607 and 0.718). Both thresholds for maximum loss (at 3.23% decay per day) and for the initial loss rate (at 1.98% per day) proved to be significant predictors of mortality. CONCLUSIONS: The innovative AI-based PMA segmentation method proved robust and effortless, enabling the first comprehensive assessment of muscle wasting in a large cohort of intensive care pancreatitis patients. Findings revealed significant muscle wasting (48.20% on average), particularly notable in overweight individuals. Higher rates of initial and maximum muscle loss, detectable early, correlated strongly with survival. Integrating this tool into routine clinical practice will enable continuous muscle status tracking and early identification of those at risk for unfavorable outcomes.

The value of non-enhanced MRI in the evaluation of patients with suspected idiopathic inflammatory myopathy.

INTRODUCTION/AIMS: The performance of magnetic resonance imaging (MRI) for diagnosing suspected idiopathic inflammatory myopathy (IIM) remains controversial. Furthermore, the role of contrast-enhanced magnetic resonance imaging (CE-MRI) sequences is unclear. The aim of this study was to evaluate the sensitivity and specificity of a non-enhanced magnetic resonance imaging (NE-MRI) protocol compared to a CE-MRI protocol in adult patients with confirmed IIM. METHODS: This study retrospectively enrolled patients with suspected IIM who underwent MRI of the upper thigh between 2008 and 2020. The protocol consisted of a T1-weighted (T1w) sequence, a turbo inversion recovery magnitude (TIRM) sequence and a contrast-enhanced T1-weighted sequence (CE-T1w). After randomly stratifying patients into a group with only the T1w and TIRM sequences available and another group with additional availability of CE-T1w, three blinded readers assessed the presence of IIM based on characteristic imaging features. Confirmation of the diagnosis was determined based on the 2017 ACR/EULAR criteria. RESULTS: Of the 80 patients (mean age 49.0 ± 21.1 years; 42 female, 38 male) included, 54 (67.5%) had a positive diagnosis of IIM. Cumulated sensitivity and specificity for MRI to detect IIM was 87.1% and 83.3% in the NE-MRI group versus 87.0% and 63.0% in the CE-MRI group. The group differences for sensitivity and specificity were non-significant for each of the three readers, respectively (p ≥ .081). DISCUSSION: NE-MRI detects suspected IIM with high diagnostic accuracy and performs equivalently to CE-MRI. Therefore, it may be appropriate to omit the use of contrast agents in MRI scans performed for suspected IIM.

Prediction of regional lymph node metastasis in intrahepatic cholangiocarcinoma: it's not all about size.

OBJECTIVES: Lymph node metastases (LNM) are frequent in patients with intrahepatic cholangiocarcinoma (iCC) and worsen their prognosis even after surgery. Our aim was to investigate the predictive value of lymph node (LN) short axis, the most common discriminator for identifying LNM in tumor-imaging and to develop a predictive model for regional LNM in iCC taking computed tomography (CT) features of extranodal disease into account. MATERIALS AND METHODS: We enrolled 102 patients with pathologically proven iCC who underwent CT prior to hepatic resection and hilar lymph node dissection (LND) from 2005 to 2021. Two blinded radiologists assessed various imaging characteristics and LN diameters, which were analyzed by bivariate and multivariate logistic regression to develop a prediction model for LNM. RESULTS: Prevalence of LNM was high (42.4 %) and estimated survival was shorter in LN-positive patients (p = 0.07). An LN short axis diameter of ≥ 9 mm demonstrated the highest predictive power for LNM. Three additional, statistically significant imaging features, presence of intrahepatic metastasis (p = 0.003), hilar tumor infiltration (p = 0.003), and tumor growth along the liver capsule (p = 0.004), were integrated into a prediction model, which substantially outperformed use of LN axis alone in ROC analysis (AUC 0.856 vs 0.701). CONCLUSIONS: LN diameter alone proved to be a relevant but unreliable imaging-marker for LNM prediction in iCC. Our proposed prognostic model, which additionally considers intrahepatic metastases and hilar and capsular infiltration, significantly improves discriminatory power. Hilar and capsular involvement might indicate direct tumor extension to lymphatic liver structures.

Interventional Treatment Strategies in Intrahepatic Cholangiocarcinoma and Perspectives for Combined Hepatocellular-Cholangiocarcinoma.

cHCC-CCA is an uncommon type of liver cancer that exhibits clinical and pathological characteristics of both hepatocellular carcinoma (HCC) and cholangiocarcinoma (CCA), which are the two main forms of primary liver cancer. The similarity to HCC and CCA makes therapeutical strategies challenging. The poor prognosis of CCA in general, as well as for cHCC-CCA, is mainly attributable to the fact that diagnosis is often at an advanced stage of disease. During the last decade, locoregional therapies usually performed by interventional radiologists and its established role in HCC treatment have gained an increasing role in CCA treatment as well. These comprise a wide range of options from tumor ablation procedures such as radiofrequency ablation (RFA), microwave ablation (MWA), computed tomography high-dose rate brachytherapy (CT-HDRBT), and cryoablation to transarterial chemoembolization (TACE), including the option of intra-arterial administration of radioactive spheres (transarterial radioembolization-TARE), and much attention has focused on the potential of individual concepts in recent years. The purpose of this review is to provide an overview of current radiologic interventions for CCA (excluding options for eCCA), to review and appraise the existing literature on the topic, and to provide an outlook on whether such interventions may have a role as treatment for cHCC-CCA in the future.

Treatment of right hepatic artery stump bleeding after pylorus-preserving pancreaticoduodenectomy by covered stent endoprosthesis placement.

Serious complications after pancreaticoduodenectomy include rupture of pseudoaneurysms arising from pancreatic fistula and pancreatojejunostomy leakage. We report a case of successful endovascular minimally invasive treatment using a covered stent endoprosthesis of a right hepatic artery stump bleeding following pylorus-preserving pancreaticoduodenectomy that was not suitable for coil or glue embolization due to an insufficiently short neck.

CT-Based Risk Stratification for Intensive Care Need and Survival in COVID-19 Patients-A Simple Solution.

We evaluated a simple semi-quantitative (SSQ) method for determining pulmonary involvement in computed tomography (CT) scans of COVID-19 patients. The extent of lung involvement in the first available CT was assessed with the SSQ method and subjectively. We identified risk factors for the need of invasive ventilation, intensive care unit (ICU) admission and for time to death after infection. Additionally, the diagnostic performance of both methods was evaluated. With the SSQ method, a 10% increase in the affected lung area was found to significantly increase the risk for need of ICU treatment with an odds ratio (OR) of 1.68 and for invasive ventilation with an OR of 1.35. Male sex, age, and pre-existing chronic lung disease were also associated with higher risks. A larger affected lung area was associated with a higher instantaneous risk of dying (hazard ratio (HR) of 1.11) independently of other risk factors. SSQ measurement was slightly superior to the subjective approach with an AUC of 73.5% for need of ICU treatment and 72.7% for invasive ventilation. SSQ assessment of the affected lung in the first available CT scans of COVID-19 patients may support early identification of those with higher risks for need of ICU treatment, invasive ventilation, or death.