Can diffusion-weighted magnetic resonance imaging predict tumor recurrence of uterine cervical cancer after concurrent chemoradiotherapy?

Purpose

To retrospectively investigate the utility of diffusion-weighted imaging (DWI) for predicting clinical outcome after concurrent chemoradiotherapy (CCRT) in uterine cervical cancer.

Materials and methods

Seventy-four consecutive patients with biopsy-proven cervical cancer who received CCRT underwent DWI at 3T. All patients had MR examinations before therapy (preTx) and at 4 weeks of initiating therapy (midTx). At each point, ADC (apparent diffusion coefficient) was measured in the tumors and ADC change between preTx and midTx were also calculated. For predicting tumor recurrence, MR variables and clinical variables were evaluated and the results were compared.

Results

During a mean follow-up of 32.1 months, tumor recurrence developed in 15 (20%) patients: local recurrence (n = 7), distant metastasis (n = 5), and both (n = 3). MidTx tumor ADCs and tumor ADC changes between preTx and midTx were significantly different between the recurrence and non-recurrence groups (P < 0.05), while preTx tumor ADCs were not significantly different between the groups (P = 0.892). Univariate analysis revealed that histologic type, stage, preTx tumor size and volume, and tumor ADC change were significantly related to tumor recurrence (all P < 0.05). However, on multivariate analysis, tumor ADC changes [hazard ratio (HR) 0.886; 95% confidence interval (CI) 0.836–0.940; P = 0.001] and histological type (HR 6.063; 95% CI 1.404–26.187; P = 0.016) were the significant independent predictors of tumor recurrence.

Conclusion

Tumor ADC changes between preTx and midTx might be a useful biomarker for the prediction of cervical cancer recurrence after CCRT.

     

Superselective transcatheter arterial embolization in patients with acute peripancreatic bleeding complications: review of 44 cases

Purpose

To evaluate the efficacy of superselective transcatheter arterial embolization (TAE) in the treatment of acute peripancreatic bleeding complications.

Methods

During a 9-year period, 44 patients with acute bleeding of the peripancreatic arteries underwent TAE in our institution. Thirty-eight patients were treated using microcatheters and 6 patients with a diagnostic catheter. Embolic agents included coils (n = 38), polyvinyl alcohol (PVA) particles (n = 2), isobutyl cyanoacrylate (n = 2), coils plus PVA particles (n = 1), and coils plus isobutyl cyanoacrylate (n = 1). Outcome measures included technical success, clinical success, and the rate of complications.

Results

Identified bleeding sources included gastroduodenal artery (n = 14), splenic artery (n = 9), pancreaticoduodenal artery (n = 6), common hepatic artery (n = 5), superior mesenteric artery branches (n = 4), proper hepatic artery (n = 3), and dorsal/transverse pancreatic artery (n = 3). Technical success with effective control of active bleeding was achieved in 41/44 patients (93 %). Clinical success attributed to TAE alone was documented in 40/44 patients (91 %). The rate of major complications was 2 % including death in one patient.

Conclusions

Superselective TAE allows effective, minimally invasive control of acute peripancreatic bleeding complications with a low rate of therapeutically relevant complications.

     

Efficacy of the echo pattern classification of ovarian tumors 2000 in conjunction with transvaginal ultrasonography for diagnosis of ovarian masses

Purpose

Because of the need for rapid, accurate clinical differentiation between malignant and benign ovarian masses, we investigated the diagnostic efficacy of the echo pattern classification used together with transvaginal ultrasound.

Methods

We classified, on the basis of six echo pattern types, transvaginal ultrasound images of 405 ovarian masses treated surgically between January 2011 and December 2012. We compared the resulting classifications to the postoperative histopathologic diagnoses and computed the diagnostic sensitivity and specificity of the echo pattern-based classification for malignancy.

Results

Our review yielded the following echo patterns: type I, n = 61; type II; n = 154; type III, n = 82; type IV, n = 61; type V, n = 34; and type VI, n = 13. Histopathologically, there were 75 borderline malignant/malignant tumors and 330 benign tumors. Diagnostic sensitivity was 80.0 % and specificity was 85.5 % when echo types I–III were categorized as benign and types IV–VI were categorized as malignant. Further, with respect to benign tumors: sensitivity and specificity for chocolate cysts were 85.5 and 88.4 %, respectively, and for dermoid cysts were 67.2 and 97.9 %, respectively.

Conclusions

With the echo pattern classification, ovarian masses can be diagnosed easily and accurately upon transvaginal ultrasound.

     

Central vascular structures as a characteristic finding of regenerative nodules using hepatobiliary phase gadolinium ethoxybenzyl diethylenetriaminepentaacetic acid-enhanced MRI and arterial dominant phase contrast-enhanced US

Objective

We investigated the characteristic findings of regenerative nodules (RNs) for differentiating early hepatocellular carcinoma (HCC) from high-grade dysplastic nodules (HGDNs) using magnetic resonance imaging (MRI) with gadolinium ethoxybenzyl diethylenetriaminepentaacetic acid (Gd-EOB-DTPA; EOB-MRI) and contrast-enhanced ultrasonography (CEUS) in patients with chronic liver disease.

Subjects and methods

Pathologically confirmed lesions (100 early HCCs, 7 HGDNs, and 20 RNs with a maximum diameter of more than 1 cm and mean maximal diameters of 15.5, 15.1, and 14.8 mm, respectively) were enrolled in this retrospective study. The signal intensities of these lesions during the hepatobiliary phase of EOB-MRI were investigated, and findings characteristic of RNs using this modality were also evaluated using CEUS.

Results

Ninety-eight of the 100 early HCCs that were hypo-intense (n = 95), iso-intense (n = 2), or hyper-intense (n = 1) and the seven HGDNs that were hypo-intense (n = 6) or hyper-intense (n = 1) during the hepatobiliary phase of EOB-MRI exhibited centripetal vessels during the arterial dominant phase of CEUS, although one early HCC that was hypo-intense exhibited both centrifugal and centripetal vessels. Eighteen of the 20 RNs and one early HCC that were hyper-intense with a small central hypo-intensity and the remaining two RNs that were hyper-intense on EOB-MRI exhibited centrifugal vessels during the arterial dominant phase of CEUS. The small central hypo-intense area corresponded to central vascular structures in the lesion, such as the hepatic artery and portal vein running from the center to the periphery, when viewed using CEUS.

Conclusion

Central vascular structures may be a characteristic finding of RNs when observed during the hepatobiliary phase of EOB-MRI and the arterial dominant phase of CEUS.

     

Readout-segmented echo-planar imaging in diffusion-weighted imaging of the kidney: comparison with single-shot echo-planar imaging in image quality

Objective

The purpose of this study was to compare the image quality of readout-segmented echo-planar imaging (RS-EPI) and that of standard single-shot echo-planar imaging (SS-EPI) in the kidney in a rat model.

Materials and methods

Twelve Wistar rats undergoing MRI examinations were imaged with two diffusion-weighted (DW) imaging protocols: a standard SS-EPI and a new RS-EPI protocol, both with a 1.0 × 1.0 × 3.0 mm voxel. The two groups of diffusion-weighted images were independently scored on geometric distortion, image blurring, signal dropout, and the overall image quality by two radiologists. Signal-to-noise ratio (SNR) and apparent diffusion coefficient (ADC) were measured on both sequences. Inter-rater agreement (IRA) was evaluated by Fleiss kappa (κ) and inter-class correlation coefficient (ICC) statistics. Comparisons of image qualities were made by Wilcoxon signed-rank test and paired-sample t test.

Results

Both RS-EPI and SS-EPI had good IRAs in scoring image qualities (κ = 0.607–0.833) and measuring renal ADCs (ICC = 0.828–0.945). Compared to SS-EPI, RS-EPI produced less geometric distortion (median score 1.5 versus 2.5, p < 0.0001), less image blurring (1.75 versus 2.0, p = 0.0003), less signal dropout (1.0 versus 3.0, p = 0.0001), and a lower score in overall image artifacts (4.25 versus 7.25; p < 0.0001). RS-EPI had higher SNR of renal DW images than SS-EPI (p < 0.001). The intra-variability of ADCs in cortex, outer medulla, and inner medulla ranged from 9.6 % to 11.1 % (Pearson correlation coefficient ρ = 0.675–0.729; p < 0.001) between the two protocols.

Conclusion

We showed that for DWI of the kidney at 1.0 × 1.0 × 3.0 mm³ voxel sizes, the new protocol provided better image quality than standard SS-EPI protocol.

     

The usefulness of a computer-aided diagnosis scheme for improving the performance of clinicians to diagnose non-mass lesions on breast ultrasonographic images

Purpose

The purpose of this study was to evaluate the usefulness of a computer-aided diagnosis (CAD) scheme for improving the performance of clinicians to diagnose non-mass lesions appearing as hypoechoic areas on breast ultrasonographic images.

Methods

The database included 97 ultrasonographic images with hypoechoic areas: 48 benign cases [benign lesion with benign mammary tissue or fibrocystic disease (n = 20), fibroadenoma (n = 11), and intraductal papilloma (n = 17)] and 49 malignant cases [ductal carcinoma in situ (n = 17) and invasive ductal carcinoma (n = 32)]. Seven clinicians, three expert breast surgeons, and four general surgeons participated in the observer study. They were asked their confidence level concerning the possibility of malignancy in all 97 cases with and without the use of the CAD scheme. Receiver operating characteristic (ROC) analysis was performed to evaluate the usefulness of the CAD scheme.

Results

The areas under the ROC curve (AUC) improved for all observers when they used the CAD scheme and increased from 0.649 to 0.783 (P = 0.0167). Notably, the AUC for the general surgeon group increased from 0.625 to 0.793 (P = 0.045).

Conclusions

This study showed that the performance of clinicians to diagnose non-mass lesions appearing as hypoechoic areas on breast ultrasonographic images was improved by the use of a CAD scheme.

     

Value of diffusion-weighted MRI and apparent diffusion coefficient measurements for predicting the response of locally advanced rectal cancer to neoadjuvant chemoradiotherapy

Purpose

The aim of our study was to assess the performance value of magnetic resonance imaging (MRI) in the restaging of locally advanced rectal cancer after neoadjuvant chemoradiotherapy (CRT) and in the identification of good vs. poor responders to neoadjuvant therapy.

Materials and Methods

A total of 34 patients with locally advanced rectal cancer underwent MRI prior to and after CRT. T stage and tumor regression grade (TRG) on post-CRT MRI was compared with the pathological staging ypT and TRG. Tumor volume and the apparent diffusion coefficient (ADC) were measured using diffusion-weighted imaging (DWI) before and after neoadjuvant CRT; the percentage of tumor volume reduction and the change of ADC (ΔADC) was also calculated. ADC parameters and the percentage of tumor volume reduction were correlated to histopathological results. The diagnostic performance of ADC and volume reduction to assess tumor response was evaluated by calculating the area under the ROC curve and the optimal cut-off values.

Results

A significant correlation between the T stage and the TRG defined in DW-MRI after CRT and the ypT and the TRG observed on the surgical specimens was found (p = 0.001; p < 0.001). The mean post-CRT ADC and ΔADC in responder patients was significantly higher compared to non-responder ones (p = 0.001; p = 0.01). Furthermore, the mean post-CRT ADC values were significantly higher in tumors with T-downstage (p = 0.01).

Conclusion

DW-MRI may have a significant role in the restaging and in the evaluation of post-CRT response of locally advanced rectal cancer. Quantitative analysis of DWI through ADC map may result in a promising noninvasive tool to evaluate the response to therapy.

     

Quality indicators of continuous renal replacement therapy (CRRT) care in critically ill patients: a systematic review

Objectives

Renal replacement therapy is increasingly utilized in the intensive care unit (ICU), of which continuous renal replacement therapy (CRRT) is most common. Despite CRRT being a relatively invasive and resource intensive technology, there remains wide practice variation in its application. This systematic review appraised the evidence for quality indicators (QIs) of CRRT care in critically ill patients.

Design

A comprehensive search strategy was developed and performed in five citation databases (Medline, Embase, CINAHL, Cochrane Library, and PubMed) and select grey literature sources. Two reviewers independently screened, selected, and extracted data using standardized forms. Each retrieved citation was appraised for quality using the Newcastle–Ottawa Scale (NOS) and Cochrane risk of bias tool. Data were summarized narratively.

Measurements and main results

Our search yielded 8374 citations, of which 133 fulfilled eligibility. This included 97 cohort studies, 24 randomized controlled trials, 10 case-control studies, and 2 retrospective medical audits. The quality of retrieved studies was generally good. In total, 18 QIs were identified that were mentioned in 238 instances. Identified QIs were classified as related to structure (n = 4, 22.2 %), care processes (n = 9, 50.0 %), and outcomes (n = 5, 27.8 %). The most commonly mentioned QIs focused on filter lifespan (n = 98), small solute clearance (n = 46), bleeding (n = 30), delivered dose (n = 19), and treatment interruption (n = 5). Across studies, the definitions used for QIs evaluating similar constructs varied considerably. When identified, QIs were most commonly described as important (n = 144, 48.3 %), scientifically acceptable (n = 32, 10.7 %), and useable and/or feasible (n = 17, 5.7 %) by their primary study authors.

Conclusions

We identified numerous potential QIs of CRRT care, characterized by heterogeneous definitions, varying quality of derivation, and limited evaluation. Further study is needed to prioritize a concise inventory of QIs to measure, improve, and benchmark CRRT care for critically ill patients.

Systematic review registration

PROSPERO CRD42015015530.

     

MR comparative study of combined hepatocellular-cholangiocarcinoma in normal,fibrotic, and cirrhotic livers

Purpose

To compare MR imaging features of combined hepatocellular-cholangiocarcinoma (cHCC-CC) in normal, fibrotic, and cirrhotic livers.

Methods

A total of 64 patients with 67 pathologically proven cHCC-CCs were retrospectively analyzed. Patients were classified into three groups according to the patients’ liver condition: patients with normal liver (F0, group 1), fibrosis without cirrhosis (F1–3, group 2), and cirrhosis (F4, group 3). The morphological and MR signal features on T1- and T2-weighted, dynamic contrast-enhanced, diffusion-weighted imaging, as well as the accompanying imaging findings, were evaluated and compared.

Results

There were 12, 19, and 33 patients in groups 1, 2, and 3, respectively. Tumors in the fibrotic and cirrhotic livers were smaller than those in the normal liver, and tumors with cirrhosis had the smallest size (P = 0.0326). No statistical difference was found when comparing the signal intensity on T2-weighted imaging (P = 0.496), but iso- or hypointense lesions were only found in the fibrosis (n = 2) or cirrhosis group (n = 2). Enhancement pattern was different between groups, the washout pattern was more often seen in the cirrhosis group (P = 0.049), and the accompanying mosaic architecture was also more commonly seen in the cirrhosis group (P = 0.048). The ADC values of the lesions were not different among the three groups (P = 0.899).

Conclusion

MRI may provide valuable information for the diagnosis and differential diagnosis of cHCC-CC in normal, fibrotic, and cirrhotic livers. The nodule size, enhancement pattern, and the presence of mosaic architecture in cHCC-CC differ between different degrees of background liver disease.

     

Prevalence of benign focal liver lesions: ultrasound investigation of 45,319 hospital patients

Purpose

The aim of the study was to determine the sonographic prevalence of benign focal liver lesions on the basis of a population of hospital patients.

Methods

The ultrasound results in a population of (n = 45,319) hospital patients over a period of 10 years were examined retrospectively and evaluated for the diagnosis of benign focal liver lesions [hepatic cysts, hepatic hemangioma, focal nodular hyperplasia (FNH), hepatic adenoma, and focal fatty sparing]. Results that were incomplete or ambiguous were excluded from this study.

Results

At least one of the lesions to be investigated was diagnosed in 15.1% (n = 6839) of the patients of the total population. The most commonly recorded lesion, with a total prevalence of 6.3% (n = 2839), was focal fatty sparing, followed by hepatic cysts with 5.8% (n = 2631). The prevalence of hepatic hemangioma was 3.3% (n = 1640), while that of FNH was 0.2% (n = 81) and that of hepatic adenoma was 0.04% (n = 19). An association between the occurrence of benign focal liver lesions and age was observed.

Conclusions

The calculated prevalence of benign focal liver lesions shows that on the fortuitous discovery of space-occupying lesions of the liver, first consideration should be given to focal fatty sparing, simple hepatic cysts and hemangiomas. The finding of a FNH or an adenoma is rarely a random discovery.

     

Randomized controlled pilot trial of mindfulness-based stress reduction compared to psychoeducational support for persistently fatigued breast and colorectal cancer survivors

Purpose

Cancer-related fatigue (CRF) is a disruptive symptom for many survivors. Despite promising evidence for efficacy of mindfulness-based stress reduction (MBSR) in reducing CRF, no trials comparing it to an active comparator for fatigued survivors have been published. The purpose of this trial was to compare MBSR to psychoeducation for CRF and associated symptoms.

Methods

Breast (n = 60) and colorectal (n = 11) cancer survivors (stage 0–III) with clinically significant CRF after completing chemotherapy and/or radiation therapy an average of 28 months prior to enrollment were randomized to MBSR or psychoeducation/support groups (PES). MBSR focused on mindfulness training; PES focused on CRF self-management. Outcomes included CRF interference (primary), CRF severity and global improvement, vitality, depression, anxiety, sleep disturbance, and pain. Outcomes were assessed at baseline (T1), post-intervention (T2), and 6-month follow-up (T3) using intent-to-treat analysis.

Results

Between-group differences in CRF interference were not significant at any time point; however, there was a trend favoring MBSR (d = ?0.46, p = 0.073) at T2. MBSR participants reported significantly greater improvement in vitality (d = 0.53, p = 0.003) and were more likely to report CRF as moderately to completely improved compared to the PES group (χ2 (1) = 4.1765, p = 0.041) at T2. MBSR participants also reported significantly greater reductions in pain at T2 (d = 0.53, p = 0.014). In addition, both MBSR and PES produced moderate-to-large and significant within-group improvements in all fatigue outcomes, depression, anxiety, and sleep at T2 and T3 compared to T1.

Conclusion

MBSR and PES appear efficacious for CRF and related symptoms. Larger trials including a usual care arm are warranted.

Trial Registration

ClinicalTrials.gov Identifier: NCT01724333.

     

Prevalence of hepatic lesion types defined by T2-weighted and dynamic gadolinium-enhanced MR imaging in patients with metastasized neuroendocrine tumors

Purpose

Identifying liver metastases from neuroendocrine tumors (NETs) is a pretherapeutic challenge in patients who are candidates for liver resection. The aims of our study are to characterize and determine the frequency of different MRI characteristics of liver metastases caused by NETs in a lesion-by-lesion analysis and to determine the frequency of monomorphous and polymorphous metastases in a patient-by-patient analysis.

Methods

This retrospective study involved 47 patients with liver metastases arising from histologically confirmed NETs. In a lesion-by-lesion analysis, we classified these metastases according to their MRI characteristics as follows: hypervascular lesions with homogeneous or peripheral enhancement, hypovascular lesions, pure cystic lesions, and mixed solid/cystic lesions. In the patient-by-patient analysis, we distinguished patients whose metastases had the same MRI characteristics from patients with mixed lesion characteristics.

Results

A total of 376 metastases were analyzed. Of these, 84.3% (n = 317) were hypervascular, with 51.9% showing homogeneous enhancement and 32.4% (n = 122) showing peripheral enhancement. Another 7.4% (n = 28) were hypovascular, 5.3% (n = 20) were pure cystic, and 2.9% (n = 11) were mixed solid/cystic. After excluding three patients with solitary lesions, 40.9% of patients (n = 18) had mixed-type lesions, consisting of hypervascular lesions with either homogeneous or peripheral enhancement in 27.3% of cases (n = 12), while 59.1% of patients (n = 26) had identical lesions.

Conclusion

Approximately 15% of metastases have atypical MRI characteristics and are either hypovascular or cystic. Metastases with different MRI characteristics coexist in 40% of patients.

     

Histogram analysis of noncancerous liver parenchyma on gadoxetic acid-enhanced MRI: predictive value for liver function and pathology

Purpose

To clarify whether the heterogeneity of hepatic parenchyma in the hepatobiliary phase on gadoxetic acid-magnetic resonance (MR) imaging is correlated with liver damage.

Materials and methods

We retrospectively examined the cases of 98 patients with or without chronic liver disease who underwent gadoxetic acid-enhanced 3T MR imaging before a hepatectomy between December 2010 and October 2014. For the evaluation of the heterogeneity of the signal intensity in the hepatobiliary phase, we placed the region of interest on the hepatic parenchyma, and the skewness and kurtosis were calculated using ImageJ software. A discriminant analysis was performed to examine the routine preoperative laboratory test results including indocyanine green retention at 15 min (ICG-R15), necro-inflammation grade, and liver fibrosis stage according to the METAVIR system: A0/1 (n = 69) and A2 (n = 29); F0/1 (n = 47), F2/3 (n = 31), and F4 (n = 20).

Results

The combination of skewness and kurtosis could discriminate the high ICG-R15 (>20) and low (<20) groups (lambda; 0.925, p = 0.025), necro-inflammatory grade (lambda; 0.926, p = 0.026), and fibrosis stage (lambda; 0.752, p < 0.0001) with statistical significance. The difference between the patients with normal values and those with an abnormal platelet count or aspartate transaminase level was also detectable (lambda; 0.901, p < 0.007, and lambda; 0.864, p = 0.001, respectively).

Conclusion

Histogram analyses of the hepatobiliary phase of gadoxetic acid-enhanced MR imaging have potential as a biomarker for the assessment of liver function, liver fibrosis, and necro-inflammation.

     

Early-stage clear cell tubulopapillary renal cell carcinoma: imaging features and distinction from clear cell and papillary subtypes

Purpose

Clear cell tubulopapillary renal cell carcinoma (CCTPRCC) is a recently described, low-grade subtype of renal cancer. We determined if imaging features could be used to distinguish early-stage CCTPRCC from stage-matched clear cell RCC (ccRCC) and papillary RCC (pRCC).

Methods

This IRB-approved retrospective study included 54 stage T1a patients with pathologically confirmed CCTPRCC (n = 18), ccRCC (n = 18), and pRCC (n = 18). CT (n = 48) and MRI (n = 27) exams were reviewed and imaging features compared. Continuous variables were evaluated using ANOVA and Tukey’s multiple comparison tests. Categorical variables were compared using Chi-square test or Fisher’s exact test.

Results

Compared to pRCC, CCTPRCC had a lower mean attenuation value on unenhanced CT (p < 0.017), was more often hyperintense on T2-weighted images (p < 0.0001), showed an ill-defined margin (p = 0.003), and demonstrated nonenhancing areas (p = 0.0003). The presence of all three of these statistically significant features [hypoattenuation (unenhanced attenuation ≤25 HU), ill-defined margin, nonenhancing areas] yielded an area under the receiver operator curve (ROC) of 0.92 (95% CI 0.83–0.99) for differentiating CCTPRCC from pRCC. There were no significant differences in the imaging features of CCTPRCC and ccRCC.

Conclusions

Early-stage clear cell tubulopapillary renal cell carcinoma can be distinguished from papillary RCC based on low attenuation on unenhanced CT, high intensity on T2-weighted images, an ill-defined margin, and presence of nonenhancing areas, but cannot be distinguished from clear cell RCC.

     

A Randomized Trial Investigating the Pharmacokinetics,Pharmacodynamics, and Safety of Subcutaneous Semaglutide Once-Weekly in Healthy Male Japanese and Caucasian Subjects

Introduction

Semaglutide is a glucagon-like peptide-1 analogue for once-weekly subcutaneous treatment of type 2 diabetes. This trial compared the pharmacokinetics, pharmacodynamics, and safety of semaglutide in Japanese and Caucasian subjects.

Methods

In this single-center, double-blind, parallel-group, 13-week trial, 44 healthy male subjects (22 Japanese, 22 Caucasian) were randomized within each race to semaglutide 0.5 mg (n = 8), 1.0 mg (n = 8), placebo 0.5 mg (n = 3) or 1.0 mg (n = 3). The primary endpoint was semaglutide exposure at steady state [area under the curve (AUC_0–168h)].

Results

Steady-state exposure of semaglutide was similar for both populations: AUC_0–168h estimated race ratio (ERR), Japanese/Caucasian: 0.5 mg, 1.06; 1.0 mg, 0.99; maximum concentration (C_max) ERR: 0.5 mg, 1.06; 1.0 mg, 1.02. Exposure after the first dose (0.25 mg) was slightly higher in Japanese versus Caucasian subjects (AUC_0–168h ERR 1.11; C_max ERR 1.14). Dose-dependent increases in AUC_0–168h and C_max occurred in both populations. Accumulation was as expected, based on the half-life (t_1/2, ~ 1 week) and dosing interval of semaglutide. Significant body weight reductions were observed with semaglutide 0.5 mg and 1.0 mg in Japanese (both p ≤ 0.05) and Caucasian (both p ≤ 0.05) subjects versus placebo. No new safety issues were identified.

Conclusions

The pharmacokinetic, pharmacodynamic, and safety profiles of semaglutide were similar in Japanese and Caucasian subjects, suggesting that no dose adjustment is required for the clinical use of semaglutide in Japanese subjects.

Funding

Novo Nordisk A/S, Denmark.

Trial registration

ClinicalTrials.gov identifier NCT02146079. Japanese trial registration number JapicCTI-142550.

     

Complementary and Alternative Medicine Treatments for Generalized Anxiety Disorder: Systematic Review and Meta-analysis of Randomized Controlled Trials

Introduction

The objective was to evaluate efficacy/safety of complementary and alternative medicine (CAM) methods for generalized anxiety disorder (GAD) based on randomized controlled trials in adults.

Methods

Data sources. Six electronic databases (“generalized anxiety (disorder)” and “randomized trial”) and reference lists of identified publications were searched to March 2017. Study selection. Eligibility: full-text publications (English, German language); CAM versus conventional treatment, placebo/sham or no treatment; GAD diagnosed according to standard criteria; and a validated scale for disease severity. Of the 6693 screened records, 32 were included (18 on biologically-based therapies, exclusively herbal preparations; eight on manipulative and body-based therapies; and three on alternative medical systems and three on mind–body therapies). Data extraction. Cochrane Collaboration methodology was used for quality assessment and data extraction.

Results

Direct comparisons of Kava Kava (Piper methysticum) extracts to placebo (4 quality trials, n = 233) were highly heterogeneous. Network meta-regression reduced heterogeneity and suggested a modest Kava effect [end-of-treatment Hamilton Anxiety scale score difference adjusted for baseline scores and trial duration: ? 3.24 (95% CI ? 6.65, 0.17; P = 0.059), Kava Kava 4 arms, n = 139; placebo 5 arms, n = 359]. Lavender (Lavandula angustifolia) extract (1 quality trial, 10 weeks, n = 523) and a combination of extracts of C. oxycantha, E. californica and magnesium (1 quality trial, 12 weeks, n = 264) were superior to placebo and balneotherapy was superior to paroxetine (1 quality trial, 8 weeks, n = 237) indicating efficacy. All other trials were small and/or of modest/low quality and/or lacked assay sensitivity. Safety reporting was poor.

Conclusion

Evidence about efficacy/safety of most CAM methods in GAD is limited. Apparent efficacy of certain herbal preparations and body-based therapies requires further confirmation.

     

Partially-covered stent placement versus surgical gastrojejunostomy for the palliation of malignant gastroduodenal obstruction secondary to pancreatic cancer

Purpose

To compare the outcomes of partially covered self-expandable metallic stent (SEMS) placement with surgical gastrojejunostomy (GJ) in patients with gastroduodenal obstruction caused by pancreatic cancer.

Methods

The medical records of 107 patients with gastroduodenal obstruction caused by pancreatic cancer who underwent fluoroscopic partially covered SEMS placement (n = 75) or surgical GJ (n = 32) at our institution were reviewed.

Results

The technical (100% vs. 100%; P > 0.999) and clinical (98.7% vs. 96.9%; P = 0.511) success rates were similar between the SEMS and GJ group. The mean gastric outlet obstruction scoring system score was higher in the SEMS group at 1 week after treatment (2.3 ± 0.5 vs. 1.2 ± 0.4; P < 0.001) but was similar between the two groups at 1 month (2.7 ± 0.5 vs. 2.8 ± 0.5; P = 0.242). The median hospital stay was shorter in the SEMS group than in the GJ group (7 vs. 14 days; P < 0.001). The overall complication (22.7% vs. 28.1%; P = 0.547) and reintervention (21.3% vs. 25.0%; P = 0.677) rates were similar between the two groups. The median patency (99 vs. 138 days; P = 0.102) and survival (106 vs. 140 days; P = 0.245) were also similar between the two groups.

Conclusion

The outcomes of partially covered SEMS placement seem to be more favorable than surgical GJ in patients with gastroduodenal obstruction caused by pancreatic cancer.

     

Comparison of hepatocellular carcinoma conspicuity on hepatobiliary phase images with gadoxetate disodium vs. delayed phase images with extracellular cellular contrast agent

Objective

To compare the conspicuity of hepatocellular carcinoma (HCC) on hepatobiliary phase of gadoxetate disodium-enhanced vs. delayed phase of gadodiamide-enhanced MR images, relative to liver function.

Methods and materials

We retrospectively identified 86 patients with newly diagnosed HCC between 2010 and 2013 and recorded the severity of liver disease by Child-Pugh class (CPC). 38 patients had gadodiamide-enhanced 5-min delayed and 48 had gadoxetate disodium-enhanced 20-min delayed hepatobiliary MR images. The conspicuity of 86 HCCs (mean size, 2.7 cm) was graded visually on a 3-point scale and quantified by liver-to-tumor contrast ratios (LTC). The relative liver parenchymal enhancement (RPE) was measured. For different CPCs, we compared the conspicuity of HCC and RPE between gadodiamide and gadoxetate.

Results

In patients with CPC A, the visual conspicuity and LTC of the 27 HCCs imaged with gadodiamide were significantly lower than those of the 38 HCCs with gadoxetate (P < 0.01, <0.01, respectively). RPE was lower in gadodiamide scans than gadoxetate scans (P < 0.01). Conversely, in patients with CPC B and C, HCCs appeared more frequently as definite hypointensity when imaged with gadodiamide (72.7%, 8/11) than gadoxetate (20%, 2/10, P = 0.03). LTC (mean 18.1 vs. 7.5, P = 0.04) and RPE (mean 75.5 vs. 45.4, P = 0.04) was significantly higher in the gadodiamide than gadoxetate scans.

Conclusion

In patients with compromised liver function, hypointensity of HCC is more conspicuous in the gadodiamide delayed phase than the gadoxetate hepatobiliary phase. This likely reflects the high extracellular accumulation of gadodiamide and poor hepatocyte uptake of gadoxetate in patients with compromised liver function.

     

Safety,efficacy, and patient-perceived satisfaction of peripherally inserted central catheters in terminally ill cancer patients: a prospective multicenter observational study

Purpose

The purpose of this study was to investigate the safety, efficacy, and subjective satisfaction of peripherally inserted central catheters (PICCs) in terminally ill cancer patients.

Methods

All PICCs were inserted by an interventional radiologist with radiological guidance. We monitored the occurrence of PICC-related complication and evaluated the patient-perceived satisfaction for PICC using semi-structured questionnaire.

Results

A total of 36 terminally ill cancer patients underwent PICC. Three patients had 2 PICC insertions; hence, finally 39 episodes during 829 PICC days were analyzed. All procedures were completed without any procedure-related complication. The median catheter life span was 19.0 days (95 % CI, 14.1–23.9). Thirty-four cases maintained the PICC until the intended time, while the other 5 cases (12.8 %; 6.1/1000 PICC days) were premature PICC removals. Totally 10 complications (25.6 %; 12.3/1000 PICC days) were reported including premature removals (n = 5), trivial bleedings (n = 3), and thrombophlebitis (n = 2). Patients reported that the procedure was not distressing (42 %), a little distressing (36 %), or distressing (21 %). Of 30 patients who had preserved cognitive function at fifth day, most patients (n = 25, 83 %) reported more comfort although the other 5 patients reported no change (n = 3) or less comfort (n = 2).

Conclusions

PICCs were safely inserted and showed favorable maintenance rate with acceptable complications. Additionally, most of the patients felt that parenteral access became much comfortable after PICC insertion. When considering the characteristics of terminally ill cancer patients, poor general condition and a limited period of survival, PICC could be a safe and effective method for intravenous access.

     

MR-imaging features of hepatocellular carcinoma capsule appearance in cirrhotic liver: comparison of gadoxetic acid and gadobenate dimeglumine

Purpose

The purpose of the study is to compare the MR-imaging features of hepatocellular carcinoma (HCC) capsule appearance on gadoxetic acid and gadobenate dimeglumine-enhanced MR imaging, using imaging-based presumptive diagnosis of HCC as the reference standard.

Methods

Gadoxetic acid and gadobenate dimeglumine-enhanced MR imaging of 51 patients with 71 HCCs were retrospectively reviewed. Three readers graded in consensus, using a five-point scale, the presence (score 4–5) of capsule appearance on images obtained during T1-weighted GRE portal venous phase (PVP), 3-min phase, and hepatobiliary phase (HBP). The Fisher's exact test and the t student unpaired test were performed.

Results

A hyperintense capsule appearance was present either on PVP or 3-min phase in 11/46 and in 24/25 HCCs imaged with gadoxetic acid and gadobenate dimeglumine-enhanced MR imaging, respectively (24% vs. 96% p < 0.001). A hypointense capsule appearance was present on HBP in 8/46 and 0/22 HCCs evaluated with gadoxetic acid and gadobenate dimeglumine-enhanced MR imaging, respectively (17% vs. 0% p = 0.046). A capsule appearance was detected either on PVP, 3-min phase, or HBP in 17/46 (37%) HCCs after gadoxetic acid injection and in 24/25 (96%) HCCs after gadobenate dimeglumine injection (p < 0.001).

Conclusions

A capsule appearance was more frequently seen on gadobenate dimeglumine-enhanced MR imaging when compared to gadoxetic acid-enhanced MR imaging.