Development and multicenter validation of deep convolutional neural network-based detection of colorectal cancer on abdominal CT.

OBJECTIVES: This study aims to develop computer-aided detection (CAD) for colorectal cancer (CRC) using abdominal CT based on a deep convolutional neural network. METHODS: This retrospective study included consecutive patients with colorectal adenocarcinoma who underwent abdominal CT before CRC resection surgery (training set = 379, test set = 103). We customized the 3D U-Net of nnU-Net (CUNET) for CRC detection, which was trained with fivefold cross-validation using annotated CT images. CUNET was validated using datasets covering various clinical situations and institutions: an internal test set (n = 103), internal patients with CRC first determined by CT (n = 54) and asymptomatic CRC (n = 51), and an external validation set from two institutions (n = 60). During each validation, data from the healthy population were added (internal = 60; external = 130). CUNET was compared with other deep CNNs: residual U-Net and EfficientDet. The CAD performances were evaluated using per-CRC sensitivity (true positive/all CRCs), free-response receiver operating characteristic (FROC), and jackknife alternative FROC (JAFROC) curves. RESULTS: CUNET showed a higher maximum per-CRC sensitivity than residual U-Net and EfficientDet (internal test set 91.3% vs. 61.2%, and 64.1%). The per-CRC sensitivity of CUNET at false-positive rates of 3.0 was as follows: internal CRC determined by CT, 89.3%; internal asymptomatic CRC, 87.3%; and external validation, 89.6%. CUNET detected 69.2% (9/13) of CRCs missed by radiologists and 89.7% (252/281) of CRCs from all validation sets. CONCLUSIONS: CUNET can detect CRC on abdominal CT in patients with various clinical situations and from external institutions. KEY POINTS: • Customized 3D U-Net of nnU-Net (CUNET) can be applied to the opportunistic detection of colorectal cancer (CRC) in abdominal CT, helping radiologists detect unexpected CRC. • CUNET showed the best performance at false-positive rates ≥ 3.0, and 30.1% of false-positives were in the colorectum. CUNET detected 69.2% (9/13) of CRCs missed by radiologists and 87.3% (48/55) of asymptomatic CRCs. • CUNET detected CRCs in multiple validation sets composed of varying clinical situations and from different institutions, and CUNET detected 89.7% (252/281) of CRCs from all validation sets.

A nationwide real-world study for evaluation of effectiveness and safety of T-DM1 in patients with HER2-positive metastatic breast cancer in Korea (KCSG BR19-15).

Purpose: This study aimed to investigate clinical practices and factors related to the outcomes of T-DM1 use in patients with HER2-positive metastatic breast cancer (mBC). Methods: We included patients with HER2-positive mBC who received T-DM1 as a palliative therapy between August 2017 and December 2018. The safety and outcomes of T-DM1, including overall response rate (ORR), progression-free survival (PFS), and overall survival (OS), were evaluated. A Cox proportional hazards model was used to estimate the hazard ratio and 95% confidence interval (CI) for mortality or progression to HER2-positive mBC. Results: In total, 824 patients were enrolled during the study period. The mean age of patients was 58 years, and 516 (62.6%) patients relapsed after curative treatment. Excluding a history of endocrine therapy, 341 (41.4%) patients previously received none or first-line chemotherapy, 179 (21.7%) received second-line therapy, and 303 (36.9%) received third-or later-line chemotherapy before T-DM1 therapy. During a median follow-up of 16.8 months, the ORR was 35%, the median PFS was 6.6 months, and the median OS was not reached. The clinical factors associated with the hazard of progression were age (<65 years), poor performance status (⩾2), advanced line of palliative chemotherapy (⩾2), prior pertuzumab use, and treatment duration of palliative trastuzumab (<10 months). Common grade 3-4 adverse events were thrombocytopenia (n = 107, 13.2%), neutropenia (n = 23, 2.8%), anemia (n = 21, 2.6%), and elevated liver enzyme (n = 20, 2.5%). Hypokalemia (⩽3.0 mmol/L) and any-grade bleeding events occurred in 25 (3.1%) and 94 (22.6%) patients, respectively. Conclusion: This is the first nationwide real-world study of T-DM1 use in patients with HER2-positive mBC in Korea. The effectiveness and toxicity profiles of T-DM1 in real-world practice were comparable to those in randomized trials. Moreover, patient factors and previous anti-HER2 therapy could predict the outcomes of T-DM1 therapy.

Pivotal Clinical Study to Evaluate the Efficacy and Safety of Assistive Artificial Intelligence-Based Software for Cervical Cancer Diagnosis.

Colposcopy is the gold standard diagnostic tool for identifying cervical lesions. However, the accuracy of colposcopies depends on the proficiency of the colposcopist. Machine learning algorithms using an artificial intelligence (AI) system can quickly process large amounts of data and have been successfully applied in several clinical situations. This study evaluated the feasibility of an AI system as an assistive tool for diagnosing high-grade cervical intraepithelial neoplasia lesions compared to the human interpretation of cervical images. This two-centered, crossover, double-blind, randomized controlled trial included 886 randomly selected images. Four colposcopists (two proficient and two inexperienced) independently evaluated cervical images, once with and the other time without the aid of the Cerviray AI® system (AIDOT, Seoul, Republic of Korea). The AI aid demonstrated improved areas under the curve on the localization receiver-operating characteristic curve compared with the colposcopy impressions of colposcopists (difference 0.12, 95% confidence interval, 0.10-0.14, p < 0.001). Sensitivity and specificity also improved when using the AI system (89.18% vs. 71.33%; p < 0.001, 96.68% vs. 92.16%; p < 0.001, respectively). Additionally, the classification accuracy rate improved with the aid of AI (86.40% vs. 75.45%; p < 0.001). Overall, the AI system could be used as an assistive diagnostic tool for both proficient and inexperienced colposcopists in cervical cancer screenings to estimate the impression and location of pathologic lesions. Further utilization of this system could help inexperienced colposcopists confirm where to perform a biopsy to diagnose high-grade lesions.

Long-term survival benefits of intrathecal autologous bone marrow-derived mesenchymal stem cells (Neuronata-R®: lenzumestrocel) treatment in ALS: Propensity-score-matched control, surveillance study.

Objective: Neuronata-R® (lenzumestrocel) is an autologous bone marrow-derived mesenchymal stem cell (BM-MSC) product, which was conditionally approved by the Korean Ministry of Food and Drug Safety (KMFDS, Republic of Korea) in 2013 for the treatment of amyotrophic lateral sclerosis (ALS). In the present study, we aimed to investigate the long-term survival benefits of treatment with intrathecal lenzumestrocel. Methods: A total of 157 participants who received lenzumestrocel and whose symptom duration was less than 2 years were included in the analysis (BM-MSC group). The survival data of placebo participants from the Pooled-Resource Open-Access ALS Clinical Trials (PROACT) database were used as the external control, and propensity score matching (PSM) was used to reduce confounding biases in baseline characteristics. Adverse events were recorded during the entire follow-up period after the first treatment. Results: Survival probability was significantly higher in the BM-MSC group compared to the external control group from the PROACT database (log-rank, p < 0.001). Multivariate Cox proportional hazard analysis showed a significantly lower hazard ratio for death in the BM-MSC group and indicated that multiple injections were more effective. Additionally, there were no serious adverse drug reactions found during the safety assessment, lasting a year after the first administration. Conclusion: The results of the present study showed that lenzumestrocel treatment had a long-term survival benefit in real-world ALS patients.

Data collection framework for electronic medical record-based real-world data to evaluate the effectiveness and safety of cancer drugs: a nationwide real-world study of the Korean Cancer Study Group.

Background: Electronic medical records (EMRs) have the highest value among real-world data (RWD). The aim of the present study was to propose a data collection framework of EMR-based RWD to evaluate the effectiveness and safety of cancer drugs by conducting a nationwide real-world study based on the Korean Cancer Study Group. Methods: We considered all patients who received ramucirumab plus paclitaxel (RAM/PTX) for gastric cancer and trastuzumab emtansine (T-DM1) for breast cancer at relevant institutions in South Korea. Standard operating procedures for systematic data collection were prospectively developed. Investigator reliability was evaluated using the concordance rate between the recommended input value for representative fictional cases and the input value of each investigator. Reliability of collected data was evaluated twice during the study period at three institutions randomly selected using the concordance rate between the previously collected data and data collected by an independent investigator. The reliability results of the investigators and collected data were used for revision of the electronic data capture system and site training. Results: Between the starting date of medical insurance coverage and December 2018, a total of 1063 patients at 56 institutions in the RAM/PTX cohort and 824 patients at 60 institutions in the T-DM1 cohort were included. Mean investigator reliability in the RAM/PTX and T-DM1 cohorts was 73.5% and 71.9%, respectively. Mean reliability of collected data in the RAM/PTX and T-DM1 cohort was 90.0% for both cohorts in the first analysis and 89.0% and 84.0% in the second analysis, respectively. Mean missing values of the RAM/PTX and T-DM1 cohorts at the time of simulation of fictional cases and final data analysis decreased from 20.7% to 0.46% and from 18.5% to 0.76%, respectively. Conclusion: This real-world study provides a framework that ensures relevance and reliability of EMR-based RWD for evaluating the effectiveness and safety of cancer drugs.

Ramucirumab plus paclitaxel as a second-line treatment in HER2-positive gastric cancer: subgroup analysis of a nationwide, real-world study in Korea (KCSG-ST19-16).

BACKGROUND: A subgroup analysis of data from a nationwide study (KCSG-ST19-16) was performed to evaluate the efficacy and safety of second-line ramucirumab plus paclitaxel treatment in patients with human epidermal growth factor receptor 2 (HER2)-positive advanced gastric or gastro-esophageal junction (GEJ) adenocarcinoma. METHODS: The KCSG-ST19-16 study enrolled a total of 1063 patients from 56 hospitals in South Korea with advanced gastric or GEJ adenocarcinoma, who had received second-line treatment with ramucirumab plus paclitaxel. HER2 status was known for 994 (93.5%) of these patients, who were thus included in the subgroup analysis. RESULTS: In total, 163 of 994 patients (16.4%), had HER2-positive gastric or GEJ adenocarcinoma. The objective response rate to ramucirumab plus paclitaxel treatment was significantly higher in patients with HER2-positive disease compared to those with HER2-negative disease (23.0% [95% confidence interval (CI), 15.9-30.1] vs. 15.1% [95% CI, 12.3-17.9], p = 0.025). The median progression-free survival was longer in patients with HER2-positive versus HER2-negative disease, but the difference was not statistically significant (4.3 months [95% CI, 3.7-5.3] vs 3.7 months [95% CI, 3.4-4.0], p = 0.054). There was no statistically significant difference in median overall survival (OS) between the groups (9.8 months [95% CI, 8.9-12.3] vs 10.1 months [95% CI, 9.2-10.9], p = 0.564). CONCLUSIONS: In patients with HER2-positive gastric or GEJ adenocarcinoma, the objective response rate to second-line treatment with ramucirumab plus paclitaxel was significantly higher compared to patients with HER2-negative disease. However, an increased response to treatment was not associated with an improvement in OS.

Accuracy of MRI for predicting anterior peritoneal reflection involvement in locally advanced rectal cancer: a comparison with operative findings.

PURPOSE: To assess the diagnostic accuracy of preoperative rectal MRI for anterior peritoneal reflection (APR) involvement in rectal cancer through comparison with the surgeon's operative findings. METHODS: This retrospective study was approved by the institutional review board; informed consent was waived. We enrolled 55 consecutive patients with suspected locally advanced mid-to-upper rectal cancer. All patients underwent rectal MRI using a 3T system. APR involvement in rectal cancer was assessed radiologically using a 5-point scale by two independent board-certified abdominal radiologists. The surgeon's evaluation during surgery was regarded as the gold standard for APR involvement. The accuracy of rectal MRI in predicting APR involvement was obtained. RESULTS: Rectal MRI showed good APR identification (rater 1, 92.7%; rater 2, 94.7%). On preoperative rectal MRI, rater 1 diagnosed 19 (34.5%) patients as having APR involvement and rater 2 diagnosed 28 (50.9%) as having APR involvement. There was moderate agreement (κ = 0.602, p < 0.001) between the two raters with regard to the evaluation of APR involvement. During surgery, the surgeon confirmed APR involvement in 13 (23.6%) patients. The sensitivity, specificity, PPV, and NPV of preoperative MRI for APR involvement were 69.2%, 76.2%, 47.4%, and 88.9%, respectively. The diagnostic accuracy of MRI for predicting APR involvement was 74.6%. CONCLUSION: Preoperative rectal MRI provides accurate anatomical information regarding APR involvement with high conspicuity. However, MRI has relatively low sensitivity (< 70%) and a low PPV (< 50%) with regard to the assessment of APR involvement in rectal tumors. Both rater 1 and rater 2 evaluated these images as positive involvement of APR. The patient underwent laparoscopic low anterior resection after preoperative evaluation. However, during surgery, the surgeon evaluated APR involvement as negative, and the final pathologic staging was confirmed as T3.

Ramucirumab plus paclitaxel as second-line treatment in patients with advanced gastric or gastroesophageal junction adenocarcinoma: a nationwide real-world outcomes in Korea study (KCSG-ST19-16).

BACKGROUND: Ramucirumab as monotherapy or in combination with paclitaxel is a second-line treatment option recommended for patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. However, real-world data from large study cohorts focused on ramucirumab plus paclitaxel in gastric cancer are limited. METHODS: The study population comprised all patients with gastric or GEJ cancer who received ramucirumab plus paclitaxel in South Korea between 1 May 2018 and 31 December 2018. We included patients with advanced gastric or GEJ adenocarcinoma and disease progression after first-line platinum and fluoropyrimidine-containing combination chemotherapy. RESULTS: In total, 1063 patients were included in the present study. The objective response rate and disease control rate were 15.1% and 57.7%, respectively. The median progression-free survival was 4.03 months (95% confidence interval, 3.80-4.27) and the median overall survival was 10.03 months (95% confidence interval, 9.33-10.73). Grade 3 or higher treatment-related adverse events with incidence of ⩾5% were neutropenia (35.1%) and anemia (10.5%). Based on multivariable analysis, overall survival was negatively associated with Eastern Cooperative Oncology Group performance status ⩾2, weight loss ⩾10% in the previous 3 months, GEJ of primary tumor, poor or unknown histologic grade, number of metastatic sites ⩾3, presence of peritoneal metastasis, no prior gastrectomy, and time to second-line since first-line treatment <6 months. CONCLUSION: Our large-scale, nationwide, real-world data analysis of an unselected real-world population adds evidence for the efficacy and safety of second-line ramucirumab plus paclitaxel in patients with locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma.

Real-world outcomes of anti-PD1 antibodies in platinum-refractory, PD-L1-positive recurrent and/or metastatic non-small cell lung cancer, and its potential practical predictors: first report from Korean Cancer Study Group LU19-05.

PURPOSE: Although immune-checkpoint inhibitors have become a new therapeutic option for recurrent/metastatic non-small cell lung cancers (R/M-NSCLC), its clinical benefit in the real-world is still unclear. METHODS: We investigated 1181 Korean patients with programmed death-1 ligand 1 (PD-L1)-positive [tumor proportion score (TPS) ≥ 10% by the SP263 assay or ≥ 50% by the 22C3 assay] R/M-NSCLC treated with pembrolizumab or nivolumab after failure of platinum-based chemotherapy. RESULTS: The median age was 67 years, 13% of patients had ECOG-PS ≥ 2, and 27% were never-smokers. Adenocarcinoma was predominant (61%) and 18.1% harbored an EGFR activating mutation or ALK rearrangement. Pembrolizumab and nivolumab were administered to 51.3% and 48.7, respectively, and 42% received them beyond the third-line chemotherapy. Objective response rate (ORR) was 28.6%. Pembrolizumab group showed numerically higher ORR (30.7%) than the nivolumab group (26.4%), but it was comparable with that of the nivolumab group having PD-L1 TPS ≥ 50% (32.4%). Median progression-free survival (PFS) and overall survival (OS) were 2.9 (95% CI 0-27.9) and 10.7 months (95% CI 0-28.2), respectively. In multivariable analysis, concordance of TPS ≥ 50% in both PD-L1 assays and the development of immune-related adverse events (irAEs) were two significant predictors of better ORR, PFS, and OS. EGFR mutation could also predict significantly worse OS outcomes. CONCLUSION: The real-world benefit of later-line anti-PD1 antibodies was comparable to clinical trials in patients with R/M-NSCLC, although patients generally were more heavily pretreated and had poorer ECOG-PS. Concordantly high PD-L1 TPS ≥ 50% and development of irAE could independently predict better treatment outcomes, while EGFR mutation negatively affected OS.

How to accurately measure the distance from the anal verge to rectal cancer on MRI: a prospective study using anal verge markers.

PURPOSE: To determine an accurate method for localizing rectal cancer using the distance from the anal verge on preoperative MRI. METHODS: This prospective study included 50 patients scheduled for MRI evaluation of rectal cancer. After rectal filling with gel, MRI was performed with two markers attached at the anal verge. The distance between the tumor and the anal verge on a sagittal T2-weighted image (T2WI) was measured independently by two radiologists using six methods divided into three groups of similar measurement approaches, and compared to those obtained on rigid sigmoidoscopy. The anal verge location relative to the external anal sphincter was assessed on oblique coronal T2WI in reference to the markers. Correlation analysis was performed using the intraclass correlation coefficient (ICC) for verification, and a paired t test was used to evaluate the mean differences. RESULTS: The highest correlation (ICC 0.797-0.815) and the least mean difference (0.74-0.85 cm) with rigid sigmoidoscopy, and the least standard deviation (3.12-3.17 cm) were obtained in the direct methods group using a straight line from the anal verge to the tumor. The anal verge was localized within a range of - 1.4 to 1.5 cm (mean - 0.31 cm and - 0.22 cm) from the lower end of the external anal sphincter. CONCLUSION: The direct methods group provided the most accurate tumor distance among the groups. Among the direct methods, we recommend the direct mass method for its simplicity. Despite minor differences in location, the lower end of the external anal sphincter was a reliable anatomical landmark for the anal verge.

How Should We Assign Large Infiltrative Hepatocellular Carcinomas for Staging?

Infiltrative gross morphology of hepatocellular carcinoma (HCC) is known to be associated with poor prognosis, but this is not considered for staging. A total of 774 HCC patients who underwent curative liver resection were retrospectively reviewed and the prognostic significance of infiltrative type HCC was assessed using the American Joint Committee on Cancer (AJCC) and Barcelona Clinic Liver Cancer (BCLC) staging systems. Seventy-four patients (9.6%) had infiltrative HCCs with a higher proportion of multifocal tumors, larger tumors, vessel invasion, increased tumor marker levels, and advanced T-stages than those with nodular HCC (all, p < 0.01). Infiltrative morphology was independently associated with lower overall survival (OS), but its impact was significant when the tumor size was ≥ 4 cm (p < 0.001). Under current AJCC and BCLC staging criteria, these large infiltrative HCCs were associated with significantly worse OS in early AJCC T-stages (T1b/T2, p < 0.001) and BCLC stage A/B (both, p < 0.01) but not in late AJCC (T3/T4) and BCLC C. The reassignment of this subtype to T3 and T4 increased the discriminatory ability of AJCC T-staging with lower AIC values (3090 and 3088 vs. 3109) and higher c-index (0.69 and 0.69 vs. 0.67), respectively (both, p < 0.001). Similarly, the reassignment of large infiltrative HCC to BCLC stages B and C also improved the prognostic performance. Large infiltrative HCCs should be assigned to more advanced stages in current staging systems for their prognostic impact.

Prognosis predictability of serum and urine renal markers in patients with decompensated cirrhosis: A multicentre prospective study.

BACKGROUND AND AIMS: This prospective observational study aimed to evaluate the best serum and urine markers to assess predictability for the prognosis of patients with decompensated cirrhosis. METHODS: Serum creatinine and cystatin C (CysC), and urinary N-acetyl-beta-D glucosaminidase (uNAG) and neutrophil gelatinase-associated lipocalin (uNGAL) levels were measured from hospitalized patients with decompensated cirrhosis. RESULTS: In total, 328 patients (mean age, 57.2 ± 12.0 years; 237 men) with decompensated cirrhosis were included. Alcoholic liver disease was the most frequent underlying liver disease (68.0%). Acute kidney injury (AKI) was concomitantly present in 41 patients (12.5%) at baseline. INR, serum creatinine and CysC levels, and uNAG and uNGAL levels were significantly higher in patients with AKI. During hospitalization, AKI had progressed in 37 patients (11.3%). In 287 patients without AKI, the incidence of AKI at 3, 6, 9 and 12 months was 15.4%, 22.2%, 28.6% and 32.5% respectively. On multivariate analysis, serum CysC and uNAG levels were independent predictors of AKI, and their optimal cut-off values were 1.055 mg/L and 23.1 U/g urinary Cr respectively. When patients were classified into three groups with these cut-off values of serum CysC and uNAG levels (group 1, both low; group 2, one of two high; and group 3, both high), progression of AKI during hospitalization (P = .001), incidence of AKI in patients without AKI at baseline (P = .001) and mortality rate (P < .001) differed significantly according to serum CysC and uNAG levels. CONCLUSION: Serum CysC and uNAG levels are useful prognostic markers for renal outcomes and mortality in patients with decompensated cirrhosis.

Prediction of the varices needing treatment with non-invasive tests in patients with compensated advanced chronic liver disease.

BACKGROUNDS & AIMS: The Baveno VI guidelines proposed criteria including liver stiffness (LS) and platelet count to avoid screening endoscopy in patients with compensated advanced chronic liver disease (cACLD). This study was performed to validate the Baveno IV criteria and to compare its diagnostic accuracy with other non-invasive models. METHODS: Patients with cACLD who underwent laboratory tests, upper gastrointestinal endoscopy and abdominal ultrasound within 6 months of transient elastography were included. RESULTS: A total of 1218 patients with cACLD were included. VNT occurred in 249 patients (20.4%). With the Baveno VI criteria, the VNT miss rate was 1.9% with a 25.7% saved endoscopy rate. Using two criteria of LS <20 kPa and platelet count >110 × 109  cells/L or LS <25 kPa and platelet count >120 × 109  cells/L, the saved endoscopy rate was 39.1% while maintaining the VNT miss rate <5%. The optimal LS and platelet count-based criteria for predicting VNT differed according to the underlying liver disease. The area under the receiver operating characteristic curve of LS-spleen diameter to platelet score (LSPS) was 0.780 (95% confidence interval: 0.774-0.820), which was significantly higher than other models. The optimal cut-off value of the LSPS for predicting VNT was 1.47. CONCLUSION: Liver stiffness and platelet count-based criteria are useful for discriminating patients with very low risk of having VNT among patients with cACLD and are partly affected by the type of underlying liver disease. Conversely, the LSPS is a predictor of VNT in patients with cACLD regardless of the type of underlying liver disease.

Gemcitabine and Docetaxel Combination for Advanced Soft Tissue Sarcoma: A Nationwide Retrospective Study.

PURPOSE: This nationwide retrospective study was conducted to evaluate the efficacy and safety of combined gemcitabine and docetaxel (GD) as an off-label therapy for advanced soft tissue sarcoma, which has limited treatment options owing to its rare occurrence. MATERIALS AND METHODS: A total of 228 patients received GD therapy for advanced soft tissue sarcoma from 2009 to 2014 in Korea. We retrospectively reviewed the clinical medical records and claims data of these patients. RESULTS: A total of 218 patients in 20 medical centers were included in the final analysis (median age, 50.0 years). The objective response rate was 15.1% (34/218, in the leiomyosarcoma subgroup; 26.3%). The median overall survival and progression-free survival were 10.3 months (95% confidence interval [CI], 8.4 to 12.2) and 3.3 months (95% CI, 2.8 to 4.7), respectively. The treatment was discontinued in 7.8% of patients owing to adverse events; however, there was no adverse event-related death. Neutropenia (35.7%) and anemia (15.1%) were the most frequent grade 3/4 toxicities. Univariate analysis for identifying the predictors of the progression-free survival period revealed that patients aged ≤ 50 years had a hazard ratio of 1.388 (95% CI, 1.027 to 1.875; p < 0.05) relative to those aged > 50 years, and the group with leiomyosarcoma had a hazard ratio of 0.693 (95% CI, 0.493 to 0.975; p < 0.05) relative to the group with other histopathological subtypes. CONCLUSION: GD therapy was tolerable and effective for Korean patients with soft tissue sarcoma. In conclusion, for patients with advanced soft tissue sarcoma, especially leiomyosarcoma, GD therapy could be an important therapeutic option.

Serum cystatin C level: An excellent predictor of mortality in patients with cirrhotic ascites.

BACKGROUND AND AIM: Although serum cystatin C level is considered a more accurate marker of renal function in patients with liver cirrhosis, its prognostic efficacy remains uncertain. This study aimed to evaluate the prognostic efficacy of serum cystatin C level in patients with cirrhotic ascites. METHODS: Patients with cirrhotic ascites from 15 hospitals were prospectively enrolled between September 2009 and March 2013. Cox regression analyses were performed to identify independent predictive factors of mortality and development of type 1 hepatorenal syndrome (HRS-1). RESULTS: In total, 350 patients were enrolled in this study. The mean age was 55.4 ± 10.8 years, and 267 patients (76.3%) were men. The leading cause of liver cirrhosis was alcoholic liver disease (64.3%), followed by chronic viral hepatitis (29.7%). Serum creatinine and cystatin C levels were 0.9 ± 0.4 mg/dL and 1.1 ± 0.5 mg/L, respectively. Multivariate analyses revealed that international normalized ratio and serum bilirubin, sodium, and cystatin C levels were independent predictors of mortality and international normalized ratio and serum sodium and cystatin C levels were independent predictors of the development of HRS-1. Serum creatinine level was not significantly associated with mortality and development of HRS-1 on multivariate analysis. CONCLUSION: Serum cystatin C level was an independent predictor of mortality and development of HRS-1 in patients with cirrhotic ascites, while serum creatinine level was not. Predictive models based on serum cystatin C level instead of serum creatinine level would be more helpful in the assessment of the condition and prognosis of patients with cirrhotic ascites.

Solar radiation increases suicide rate after adjusting for other climate factors in South Korea.

OBJECTIVE: Previous studies have indicated that suicide rates have significant seasonal variations. There is seasonal discordance between temperature and solar radiation due to the monsoon season in South Korea. We investigated the seasonality of suicide and assessed its association with climate variables in South Korea. METHOD: Suicide rates were obtained from the National Statistical Office of South Korea, and climatic data were obtained from the Korea Meteorological Administration for the period of 1992-2010. We conducted analyses using a generalized additive model (GAM). First, we explored the seasonality of suicide and climate variables such as mean temperature, daily temperature range, solar radiation, and relative humidity. Next, we identified confounding climate variables associated with suicide rate. To estimate the adjusted effect of solar radiation on the suicide rate, we investigated the confounding variables using a multivariable GAM. RESULTS: Suicide rate showed seasonality with a pattern similar to that of solar radiation. We found that the suicide rate increased 1.008 times when solar radiation increased by 1 MJ/m2 after adjusting for other confounding climate factors (P < 0.001). CONCLUSION: Solar radiation has a significant linear relationship with suicide after adjusting for region, other climate variables, and time trends.

Diagnostic performance of gadoxetic acid (Primovist)-enhanced MR imaging versus CT during hepatic arteriography and portography for small hypervascular hepatocellular carcinoma.

To compare the diagnostic performance of gadoxetic acid-enhanced magnetic resonance imaging (MRI) with that of computed tomography (CT) during hepatic arteriography and arterial portography (CT HA/AP) for detecting hepatocellular carcinoma (HCC) from small hypervascular nodules.This retrospective study included 38 patients with 131 hypervascular nodules (≤2 cm) who had underwent MRI and CT HA/AP within a 2-week interval. Two observers analyzed MRI while other 2 observers analyzed CT HA/AP. Thereafter, MRI observers reviewed the CT HA/AP and magnetic resonance (MR) images again using both modalities. HCC was diagnosed by pathologic or imaging studies according to American Association for the Study of Liver Diseases (AASLD) criteria. Alternative free-response receiver operating characteristic (ROC) analysis was performed on a lesion-by-lesion basis. Diagnostic accuracy (area under the ROC curve [Az]), sensitivity, specificity, and positive and negative predictive values were calculated.The pooled Az was significantly higher for the combined modalities (0.946) than for MRI alone (0.9, P = 0.004), and for MRI than for CT HA/AP alone (0.827, P = 0.0154). Subgroup analysis for HCC ≤1 cm showed the sensitivity of the combined modalities (79.4%) was significantly higher than for MRI (52.9%) and CT HA/AP alone (50%) (both, P < 0.005). The specificity of the combined modalities was not different from MRI alone (98.8% vs. 97.3%, P = 0.5), but was significantly higher than for CT HA/AP alone (98.8% vs. 92.5%, P = 0.022).Hypervascular HCCs >1 to 2 cm can be diagnosed sufficiently by MRI. The combined modalities increased the diagnostic accuracy of HCCs ≤1 cm, compared with MRI or CT HA/AP alone.

Transfusion Risk and Clinical Knowledge (TRACK) Score and Cardiac Surgery in Patients Refusing Transfusion.

OBJECTIVE: The Transfusion Risk and Clinical Knowledge (TRACK) score is a simple tool to predict the chance of undergoing blood transfusion in cardiac surgery. The authors evaluated the relationship between the TRACK score and clinical outcomes of cardiac surgery in patients who refused blood transfusion. DESIGN: An observational study. SETTING: A single hospital. PARTICIPANTS: Seventy-six adult Jehovah's Witnesses refusing blood transfusion who underwent cardiac surgeries. INTERVENTIONS: Patients were divided into 2 groups according to their TRACK score: low-risk group (n = 57, TRACK score of less than 13) and high-risk group (n = 19, TRACK score of 13 or more). Perioperative and long-term clinical outcomes were compared between the 2 groups. MEASUREMENTS AND MAIN RESULTS: The operative mortality was 0% in the low-risk group, and 21.1% (n = 4) in the high-risk group (p = 0.003). The incidence of major postoperative complications was higher in the high-risk group (57.9%) than in the low-risk group (17.5%) (p = 0.002). The high-risk group had more postoperative bleeding-related complications (21.1%) than did the low-risk group (1.8%) (p = 0.013). There were no significant differences of predictive performance in mortality and morbidity between the TRACK score and EuroSCORE II. CONCLUSION: In cardiac surgery patients refusing transfusions, the TRACK score predicted postoperative morbidity and mortality of cardiac surgery.

Cabrol-Type Aortocoronary Anastomosis Technique in Coronary Artery Bypass Surgery.

BACKGROUND: In conventional coronary artery bypass grafting (CABG), multiple anastomoses in the ascending aorta are needed for multiple coronary targeting. We have introduced a single-site proximal anastomosis technique for multiple coronary targeting. A single anastomosis between the ascending aorta and graft was performed using a side-to-side maneuver (Cabrol type). Additionally, the graft was connected to another graft by end-to-end anastomosis for the coronary artery on the opposite side. We evaluated the long-term clinical outcome and graft patency of this Cabrol-type aortocoronary anastomosis technique. METHODS: From 2002 to 2012, a total of 483 patients (mean age, 64.6 years) underwent CABG using our Cabrol-type aortocoronary anastomosis technique. The average number of target coronary arteries per person was 3.4 ± 0.6. The mean follow-up duration was 74.2 ± 31.3 months; 98.7% of hospital survivors completed the follow-up. Postoperative coronary computed tomography angiography was performed in 377 patients (81.8%). RESULTS: Operative mortality was 4.6%. The actuarial overall survival rates at 1, 5, and 10 years were 97.8 ± 0.7%, 89.3 ± 1.5%, and 69.0 ± 3.9%, respectively. The actuarial major adverse cardiac and cerebrovascular event-free survival rates at 1, 5, and 10 years were 95.7 ± 0.9%, 80.1 ± 2.0%, and 60.8 ± 3.7%, respectively. One- and 5-year patency rates of the Cabrol-type aortocoronary graft were 81.1 ± 2.2% and 61.3 ± 3.6%, respectively. CONCLUSION: Our Cabrol-type aortocoronary anastomosis technique did not have superior clinical outcomes and graft patency compared with conventional CABG. However, this technique might be an alternative option in select patients with atherosclerotic disease of the ascending aorta, or other embarrassing situations.

Changes in Cardiac Varices and Their Clinical Significance after Eradication of Esophageal Varices by Band Ligation.

Background and Aims. Cardiac varices (CVs) in patients with type 1 gastroesophageal varices (GOV1s) usually disappear with treatment for esophageal varices (EVs) by endoscopic injection sclerotherapy (EIS). However, whether this applies to patients treated with endoscopic band ligation (EBL) for EVs remains unclear. We evaluated the effect of EVs eradication by EBL on CVs. Methods. We included cirrhotic patients whose EVs had been eradicated using EBL and excluded those who had been treated using EIS, those who had received endoscopic therapy for CVs, and those who were combined with hepatocellular carcinoma. Results. A total of 123 patients were enrolled. The age was 59.7 ± 11.7 years, and 96 patients (78.0%) were men. Thirty-eight patients (30.9%) had EVs only, while 85 (69.1%) had GOV1s. After EVs eradication, the CVs disappeared in 55 patients (64.7%). EVs recurred in 40 patients, with recurrence rates at 1, 2, and 3 years of 16.0%, 29.6%, and 35.6%, respectively, the recurrence being more frequent in patients who had undergone EBL for secondary prophylaxis and in those with persisting CVs after EVs eradication (P = 0.003). Conclusions. CVs frequently disappeared when EVs were eradicated using EBL in patients with GOV1s. Persistence of CVs after EVs eradication by EBL was associated with EVs recurrence.