Long-Term Oncological Outcome Comparison between Intermediate- and High-Dose Radioactive Iodine Ablation in Patients with Differentiated Thyroid Carcinoma: A Propensity Score Matching StudyRead the full article
International Journal of Endocrinology publishes original research articles, review articles, and clinical studies that provide insights into the endocrine system and its associated diseases at a genomic, molecular, biochemical and cellular level.
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Impact of the 8th Edition of the AJCC-TNM Staging System on Estimated Cancer-Specific Survival in Patients Aged 45–54 Years at Diagnosis with Differentiated Thyroid Carcinoma: A Single Center Report
Background. The 8th edition of the American Joint Committee on Cancer (AJCC) staging system changed the age cutoff for risk stratification of differentiated thyroid carcinoma (DTC), downgrading patients between 45 and 54 years to stage I or II. The aim of our study was to assess cancer-specific survival (CSS) in patients aged 45–54 years, in order to document the prognostic capability of the last edition of the staging system. Methods. We retrospectively reviewed the medical records of 172 patients that from January 1st, 2005, to May 31st, 2017, were diagnosed at our institution with DTC when aged 45–54 years. We restaged patients according to the 8th edition of the staging system and estimated CSS. Results. 101 out of 172 patients (58.7%) were reallocated to a lower stage. Of the 101 downstaged patients, 88 (88.9%) showed a high or intermediate American Thyroid Association (ATA) risk of recurrence. We recorded no cancer-specific deaths. Conclusions. Risk of cancer-specific mortality in patients aged 45–54 years with DTC is low, supporting the prognostic capability of the 8th edition of the staging system. However, we recommend to consider carefully the significant proportion of patients at intermediate or high risk of recurrence in this group of patients.
Serum Levels of Irisin and Omentin-1 in Breast Neoplasms and Their Association with Tumor Histology
Breast cancer is associated with obesity, possibly due to direct effects of adipokines and myokines, such as omentin-1 and irisin. In this study, we aimed to evaluate omentin-1 and irisin levels in women with benign and/or malignant breast neoplasms vs. healthy controls. Disease-free individuals (N = 56) and patients with histologically proven benign (N = 61) or malignant tumor (N = 96; subdivided into recently diagnosed/treatment-naïve (N = 72) and chemotherapy-treated (N = 24) subgroups) were enrolled in this study. Demographic, biochemical, and tumor histological characteristics were recorded. Body composition parameters were assessed using bioelectrical impedance. Serum irisin and omentin-1 levels were quantified with ELISA kits. In adjusted models, irisin levels were higher in both benign and malignant cases compared to controls but were comparable between neoplasms. Further adjustment for omentin-1 levels showed that age (odds ratio (OR) = 1.05, 95% confidence interval (95% CI) = (1.02, 1.08), ) and irisin levels (OR = 5.30, 95% CI = (1.24, 22.38), ) were independent predictors of the presence of malignancy. These molecules were associated with each other and with other anthropometric and demographic parameters. Irisin was associated with tumor histological characteristics including Ki67% levels, Elston-Ellis grading system, and estrogen receptors status. Omentin-1 was also associated with the Elston-Ellis grading system. In conclusion, serum irisin is increased in patients with both benign and malignant diseases of the breast. When combined with omentin-1, irisin concentration was associated with the presence of breast malignancy. This molecule’s role as a potential diagnostic and/or prognostic agent in breast malignancies warrants further investigation in larger prospective studies.
Factors That Affect the Sensitivity of Imaging Modalities in Primary Hyperparathyroidism
Background. Cervical ultrasound, 99mTc-sestamibi single-photon emission computed tomography/computed tomography (99mTc-MIBI SPECT/CT), and cervical CT are routinely used in preoperative localization of primary hyperparathyroidism (PHPT). However, false-negative imaging results are also frequently encountered in clinical practice. Exploring the factors that affect the sensitivity of these imaging modalities is important for the surgical management of PHPT patients. Methods. Clinical data of 352 PHPT patients hospitalized in our center from January 2011 to December 2015 were retrospectively collected to evaluate the sensitivity of 3 imaging modalities in the preoperative localization of parathyroid lesions. The ROC curve analysis was used to explore the clinical factors affecting the sensitivity of localization, and the cut-point(s) of related factors were determined. Results. 99mTc-MIBI SPECT/CT has the highest sensitivity among the localization modalities commonly used, reaching 91.1% (86.0%–94.8%). When the lengths of parathyroid lesions were ≤1.3 cm, the sensitivity of neck ultrasonography significantly decreased, while the sensitivity of 99mTc-MIBI SPECT/CT decreased with parathyroid lesions ≤1.3 cm or serum PTH≤252 pg/ml. 99mTc-MIBI SPECT/CT was less effective in localizing the hyperplasia lesions. Neck ultrasonography combined with 99mTc-MIBI SPECT/CT can effectively improve the accuracy of preoperative localization of parathyroid lesions to 96.2% (92.7%–98.1%). Conclusions. Small parathyroid lesion and mild elevation of serum PTH would reduce the accuracy of parathyroid localization in PHPT patients.
Body Mass Index and Its Change from Adolescence to Adulthood Are Closely Related to the Risk of Adult Metabolic Syndrome in China
Aims. To investigate the influence of body mass index (BMI) and its change from adolescence to adulthood (ΔBMI) on the risk of metabolic syndrome (MetS) in early adulthood. Methods. We selected 931 students from 12 to 16 years of age in Liaoyang City, China. Ninety-three participants from 18 to 22 years of age with complete baseline data were available for follow-up after 5 years. Statistical analysis determined the relationship of MetS at follow-up with baseline BMI (BMIb), ΔBMI, and follow-up BMI (BMIf). Results. ΔBMI was positively correlated with the change of waist circumference (ΔWC), systolic blood pressure (ΔSBP), triglycerides (ΔTG), uric acid, and glycosylated hemoglobin (ΔHbA1c) in follow-up (). For every 1 kg/m2 increase in BMIb, ΔBMI, and BMIf, the risk of MetS at follow-up increased 1.201-fold, 1.406-fold, and 1.579-fold, respectively. Both BMIb and ΔBMI were predictive of MetS at follow-up, with prediction thresholds of 23.47 kg/m2 and 1.95 kg/m2. The participants were divided by the predicted BMIb and ΔBMI threshold values into four study groups. Interestingly, the group with lower BMI but a higher increase in BMI presented the same metabolic derangements and Mets% of the group with higher BMI but lower Δ BMI. Conclusion. Both BMI of adolescence and ΔBMI were predictive of MetS and cardiovascular risk factors in adulthood. Control of both variables in adolescents would be more effective in decreasing the risk of MetS in young adults than control of BMI alone.
Study Design and Data Analysis of Artificial Pancreas Device Systems with Closed-Loop Glucose-Sensing Insulin Delivery
Objective. The objective of this article is to provide a high-profile review and discussion on the study design and statistical analysis of pivotal clinical trials conducted to demonstrate the safety and effectiveness of closed-loop investigational artificial pancreas device systems (APDSs) in premarket approval applications. Methods. The United States Food and Drug Administration (FDA) guidance on the content of investigational device exemption and premarket approval applications for APDSs is reviewed with special emphasis on study design and statistical analysis of the pivotal clinical trials. The two pivotal studies for the MiniMed 670G hybrid closed-loop system by Medtronic in their premarket approval application are summarized and discussed. Results. The United States FDA established detailed recommendations on the study design and statistical analysis of pivotal clinical trials for the industry that seek market investigational APDSs and for FDA scientific reviewers that regulate the device applications. The recommendations cover specifics regarding patient population, clinical endpoints, and strategies for data analysis. However, the two pivotal studies that demonstrated the effectiveness of the FDA-approved MiniMed 670G hybrid closed-loop system were not typical randomized controlled trials as per FDA recommendations. Conclusion. The development and regulation of investigational APDSs require careful and sophisticated clinical study designs and data analysis in premarket approval applications. The regulatory evaluation process of the APDSs is rather complicated since the devices consist of multiple components that collaboratively function to mimic human pancreases.
Minor Change of Plasma Renin Activity during the Saline Infusion Test Provide an Auxiliary Diagnostic Value for Primary Aldosteronism
Context. Failure of plasma aldosterone suppression during the saline infusion test (SIT) confirms primary aldosteronism (PA); recommendations for diagnostic strategies are currently controversial in the case of an inconclusive test result with a post-SIT PAC 5–10 ng/dl, while the renin change during SIT is not focused by the previous study. Objective. To clarify whether it has some hidden diagnostic values for PA, especially in the case of an inconclusive SIT result, we investigated the difference in changes of plasma renin activity (PRA) during SIT between patients with PA and non-PA. Methods. We measured and compared the SIT parameters of 159 PA patients, 368 non-PA patients, and 43 inconclusive patients who were included in this study. Results. The PA group showed a minor change of PRA during the SIT (ΔPRA, defined as (pre-SIT PRA–post-SIT PRA)) compared with the non-PA group (0.17 ng/ml/h vs. 1.07 ng/ml/h, ). According to ROC analysis, ΔPRA showed a greater AUC than post-SIT PRA (0.897 vs. 0.855, ). The cutoff value was 0.5 ng/ml/h, with 90.3% sensitivity and 78.6% specificity. When combined with ARR post-SIT, it showed 81.6% sensitivity and 97.0% specificity for PA diagnosis. Further analysis of 43 patients with an inconclusive SIT result who completed AVS found that ΔPRA was smaller in the confirmed PA group compared with the unconfirmed PA group (0.19 ng/ml/h vs. 0.29 ng/ml/h, ); there was no significant difference in PAC post-SIT between two groups. ΔPRA ≤ 0.21 ng/ml/h provides 71.4% sensitivity, 80.0% specificity, and 87.0% PPV for their PA diagnosis. Conclusions. PA patients show minor PRA change during SIT; the change of PRA during SIT provides an auxiliary diagnostic value for PA, especially in patients with an inconclusive SIT result.