Evaluation of hybrid closed-loop insulin delivery system in type 1 diabetes in real-world clinical practice: One-year observational study.

BACKGROUND: In 2016, the Food and Drug Administration approved the first hybrid closed-loop (HCL) insulin delivery system for adults with type 1 diabetes (T1D). There is limited information on the impact of using HCL systems on patient-reported outcomes (PROs) in patients with T1D in real-world clinical practice. In this independent study, we evaluated glycemic parameters and PROs over one year of continuous use of Medtronic's 670G HCL in real-world clinical practice. AIM: To assess the effects of hybrid closed loop system on glycemic control and quality of life in adults with T1D. METHODS: We evaluated 71 patients with T1D (mean age: 45.5 ± 12.1 years; 59% females; body weight: 83.8 ± 18.7 kg, body mass index: 28.7 ± 5.6 kg/m2, A1C: 7.6% ± 0.8%) who were treated with HCL at Joslin Clinic from 2017 to 2019. We measured A1C and percent of glucose time-in-range (%TIR) at baseline and 12 months. We measured percent time in auto mode (%TiAM) for the last two weeks preceding the final visit and assessed PROs through several validated quality-of-life surveys related to general health and diabetes management. RESULTS: At 12 mo, A1C decreased by 0.3% ± 0.1% (P = 0.001) and %TIR increased by 8.1% ± 2.5% (P = 0.002). The average %TiAM was only 64.3% ± 32.8% and was not associated with A1C, %TIR or PROs. PROs, provided at baseline and at the end of the study, showed that the physical functioning submodule of 36Item Short-Form Health Survey increased significantly by 22.9% (P < 0.001). Hypoglycemia fear survey/worry scale decreased significantly by 24.9% (P < 0.000); Problem Areas In Diabetes reduced significantly by -17.2% (P = 0.002). The emotional burden submodules of dietary diversity score reduced significantly by -44.7% (P = 0.001). Furthermore, analysis of Clarke questionnaire showed no increase in awareness of hypoglycemic episodes. WHO-5 showed no improvements in subject's wellbeing among participants after starting the 670G HCL system. Finally, analysis of Pittsburgh Sleep Quality Index showed no difference in sleep quality, sleep latency, or duration of sleep from baseline to 12 mo. CONCLUSION: The use of HCL in real-world clinical practice for one year was associated with significant improvements in A1C, %TIR, physical functioning, hypoglycemia fear, emotional distress, and emotional burden related to diabetes management. However, these changes were not associated with time in auto mode.

Outcomes of Breast Intraoperative Electron Beam Radiotherapy (IOeRT) : Case Series of Single Institute Experience in Saudi Arabia.

INTRODUCTION: 85-90% of local recurrences after breastconserving surgery occurs within the index quadrant. Intraoperative radiotherapy may be a good alternative for eligible patients avoiding long course of adjuvant radiation. PATIENTS AND METHODS: Eligible patients were early stage node negative at least 50 years at time of inclusion, unicentric less than 30mm in diameter any hormone receptor status. 21 Gy was delivered intraoperatively, biologically equivalent to 58 to 60 Gy in standard fractionation using electron beam to 90% isodose line. Cosmetic, Oncological and Patient Satisfaction Evaluation of treated Patients between March 2018 and August 2020 at the King Khalid university hospital, using the IOeRT (Mobetron® ). Evaluation done at a combined clinic between surgical and radiation oncology teams at the end of the follow up period before publication. RESULTS: 15 female patients were evaluable with mean follow up period 33.8 months (19-48 months). Mean Age 56.4 years (50-65 years). Mean tumor size 1.213 cm. Majority of patients were T1. 2 patients showed Sentinel lymph node positive.21 Gy was delivered intraoperatively.4 Patients (26.7%) received adjuvant postoperative external beam radiation therapy (EBRT). 2 patients due to being in Caution group due to positive extensive Ductal carcinoma in situ (DCIS). External beam radiation was 40 Gy/15 fractions/3 weeks using three dimensional radiation therapy (3DCRT). Cosmetically, Apart from one patient score 9 due to presence of keloid scar formation, most patients were in range of 0-3 according to physician evaluation and Modified Hollander's score otherwise, No more than score 3 in any of the patients was detected. Oncologically, Till the time of publication no local or distant relapses was detected. As a patient experience, 100 % of patients were satisfied. CONCLUSION: Breast IOERT is a convenient, safe and a valid treatment modality as an option for patients who are otherwise appropriate candidates for APBI. Proper patient selection should focus on clinicopathologic factors predictive of negative nodes and negative margins. Careful assessment of preoperative mammographic and other imaging studies for features, such as extent of calcifications, may be helpful.

The safety of intravenous peripheral administration of 3% hypertonic saline: A systematic review and meta-analysis.

BACKGROUND: Three percent hypertonic saline (3% HTS) is used to treat several critical conditions such as severe and symptomatic hyponatremia and increased intracranial pressure. It has been traditionally administered through a central venous catheter (CVC). The avoidance of peripheral intravenous infusion of 3% HTS stems theoretically from the concern about the ability of the peripheral veins to tolerate hyperosmolar infusions. The aim of this systematic review and meta-analysis is to assess the rate of complications associated with the infusion of 3% HTS using peripheral intravenous access. METHODS: We conducted a systematic review and meta-analysis to assess the rate of complications related to the peripheral infusion of 3% HTS. We searched several databases for available studies that met the criteria until February 24th, 2022. We included ten studies conducted across three countries examining the incidence of infiltration, phlebitis, venous thrombosis, erythema, and edema. The overall event rate was calculated and transformed using the Freeman-Tukey arcsine method and pooled using the DerSimonian and Laird random-effects model. I2 was used to evaluate heterogeneity. Selected items from Newcastle-Ottawa Scale2 were used to assess the risk of bias in each included study. RESULTS: A total of 1200 patients were reported to have received peripheral infusion of 3% HTS. The analysis showed that peripherally administered 3% HTS has a low rate of complications. The overall incidence of each of the complications was as follows: infiltration 3.3%, (95% C.I. = 1.8-5.1%), phlebitis 6.2% (95% C.I. = 1.1-14.3%), erythema 2.3% (95% C.I. = 0.3-5.4%), edema 1.8% (95% C.I. = 0.0-6.2%), and venous thrombosis 1% (95% C.I. = 0.0-4.8%). There was one incident of venous thrombosis preceded by infiltration resulting from peripheral infusion of 3% HTS. CONCLUSIONS: Peripheral administration of 3% HTS is considered a safe and possibly preferred option as it carries a low risk of complications and is a less invasive procedure compared to CVC.

Magnitude of A1C improvement in relation to baseline A1C and amount of weight loss in response to intensive lifestyle intervention in real-world diabetes practice: 13 years of observation.

BACKGROUND: Effect of intensive lifestyle intervention (ILI) on A1C in participants with diabetes is underestimated. A1C improvement is presumed to be dependent on the amount of weight loss. Here, we evaluate the magnitude of A1C change in relation to baseline A1C and the amount of weight loss in participants with diabetes who underwent ILI over 13 years in real-world clinical practice. METHODS: A total of 590 participants with diabetes were enrolled in the Weight Achievement and Intensive Treatment (Why WAIT) program, a 12-week multidisciplinary ILI program designed for real-world clinical practice between September 2005 and May 2018. We stratified participants based on baseline A1C into three groups: group A: A1C ≥ 9%, group B: A1C 8 to <9%, and group C: A1C ≥6.5% to <8%. RESULTS: After 12-weeks of intervention, body weight decreased in all groups, and pairwise comparisons of A1C changes showed that: group A had 1.3% greater A1C reduction than group B (p = 0.0001) and 2% greater than group C (p = 0.0001), while group B had 0.7% greater A1C reduction than group C (p = 0.0001). CONCLUSION: We conclude that ILI may decrease A1C by up to 2.5% in participants with diabetes. At similar magnitude of weight loss, A1C reduction was more prominent in participants with higher baseline A1C. This may be valuable for clinicians to set a realistic expectation of A1C change in response to ILI.

Long-term effect of intensive lifestyle intervention on cardiometabolic risk factors and microvascular complications in patients with diabetes in real-world clinical practice: a 10-year longitudinal study.

INTRODUCTION: Intensive lifestyle intervention (ILI) has significantly reduced incidence of diabetes and improved many cardiovascular disease risk factors. We evaluated long-term effects of ILI on cardiometabolic risk factors, and microvascular and macrovascular complications among patients with diabetes in real-world clinical practice. RESEARCH DESIGN AND METHODS: We evaluated 129 patients with diabetes and obesity enrolled in a 12-week translational model of ILI. At 1 year, we divided participants into group A, who maintained <7% weight loss (n=61, 47.7%), and group B, who maintained ≥7% weight loss (n=67, 52.3%). We continued to follow them for 10 years. RESULTS: The total cohort lost an average of 10.8±4.6 kg (-9.7%) at 12 weeks and maintained an average weight loss of 7.7±10 kg (-6.9%) at 10 years. Group A maintained 4.3±9.5 kg (-4.3%) and group B maintained 10.8±9.3 kg (-9.3%) of weight loss at 10 years (p<0.001 between groups). In group A, A1c decreased from 7.5±1.3% to 6.7±0.9% at 12 weeks but rebounded to 7.7±1.4% at 1 year and 8.0±1.9% at 10 years. In group B, A1c decreased from 7.4±1.2% to 6.4±0.9% at 12 weeks then increased to 6.8±1.2% at 1 year and 7.3±1.5% at 10 years (p<0.05 between groups). Maintenance of ≥7% weight loss at 1 year was associated with a 68% lower risk of developing nephropathy for up to 10 years compared with maintenance of <7% weight loss (adjusted HR for group B: 0.32, 95% CI 0.11, 0.9, p=0.007). CONCLUSIONS: Weight reduction in patients with diabetes can be maintained for up to 10 years in real-world clinical practice. Sustained weight loss is associated with significantly lower A1c at 10 years and improvement in lipid profile. Maintenance of ≥7% weight loss at 1 year is associated with decreased incidence of diabetic nephropathy at 10 years.

Multidisciplinary intensive lifestyle intervention improves markers of nonalcoholic fatty liver disease (NAFLD) in patients with type 1 diabetes and obesity: a retrospective matched-cohort study.

BACKGROUND: The prevalence of non-alcoholic fatty liver disease (NAFLD) is increasing among patients with type 1 diabetes (T1D) paralleling the increasing prevalence of obesity among this population. However, little is known about the impact of intensive lifestyle intervention (ILI) on NAFLD in patients with T1D. METHODS: Using Hepatic Steatosis Index (HSI), a noninvasive surrogate predictor of NAFLD, we retrospectively evaluated 88 adult patients with T1D and obesity after one year of participating in a 12-week ILI program in real-world clinical practice. Using the NAFLD guidelines of the American Association for the Study of Liver Diseases (AASLD), we excluded 11 participants. We matched the remaining ILI cohort (age 43 ± 12 years, females 65%, diabetes duration 22 ± 9 years, A1C 8.2 ± 0.9%, body weight 101 ± 17 kg, BMI 35.3 ± 4.9 kg/m2) in 1:1 ratio with a similar cohort of patients with T1D and obesity who received standard diabetes care (SC) at the same practice and during the same period. Matching criteria included: sex, age, BMI, A1C and duration of T1D. HSI [8 + ALT/AST + BMI (+ 2 if female, + 2 if T2D)] was calculated at baseline and after 12 months of intervention. RESULTS: At baseline, HSI was similar between the two cohorts (46.2 ± 6.1 in the ILI cohort and 44.9 ± 5.7 in the SC cohort). After 12 months, the ILI group lost an average of 5.6 ± 2.7 kg (5.8%, p < 0.05) while the SC group maintained their baseline body weight (p < 0.001 between groups). HSI decreased significantly from baseline in the ILI group (-2.7 ± 1.1, p = 0.01), but did not change in the SC group (0.6 ± 0.9, p = 0.53, p < 0.001 between groups). Percentage of patients with high likelihood of NAFLD diagnosis decreased from 100% at baseline to 88.3% in the ILI group, and was 10.4% less compared to SC (p < 0.01). Total daily insulin dose decreased in the ILI cohort compared to the SC cohort (-6.1 ± 4.2 versus 1.34 ± 4.3 units/day, p < 0.01). CONCLUSIONS: Twelve weeks of ILI improved HSI and decreased total daily insulin requirements in patients with T1D and obesity at one year. Short-term ILI should be implemented in the management of NAFLD for obese patients with type 1 diabetes.

Hybrid model of intensive lifestyle intervention is potentially effective in patients with diabetes & obesity for post-COVID era.

The Weight Achievement and Intensive Treatment (Why WAIT) program is a 12-week multidisciplinary intensive lifestyle intervention (ILI) for patients with diabetes and obesity in real-world clinical practice that has led to long-term weight loss maintenance for up to 10 years. During COVID-19, we reported that a virtual model (VM) of the program was equally effective in reducing body weight and improving glycemic control. Here, we test a newly-introduced hybrid model (HM), to accommodate ongoing restrictions of the pandemic. We evaluated 56 participants: 18 from HM, 16 from VM and 22 from the in-person model (iPM). At 12 weeks, mean change in body weight from baseline for HM was -8.2 ± 5.0 kg; p<0.001. Mean change in A1C for HM was -0.6 ± 0.6%; p=0.002. There were no significant differences in body weight reduction (p=0.7) or A1C reduction (p=0.6) between groups. Blood pressure, lipid profile, and all other parameters showed improvements without significant differences between groups. Overall, HM is as effective as VM and iPM in reducing body weight and A1C after 12 weeks. Given its scalability, HM could be offered to more patients with diabetes and obesity who may benefit from its increased flexibility and enhanced accountability without compromising the multidisciplinary approach for a post-COVID era.

Concurrent capecitabine with external beam radiotherapy versus radiotherapy alone in painful bone metastasis of breast cancer origin.

BACKGROUND: In breast cancer, painful bone metastases are common. Local radiotherapy is the standard treatment of painful bone metastases. Pain control and overall response rateswere low in radiotherapy alone.The objectives of this study were to compare the safety and efficacy of external beam radiotherapy with concurrent capecitabine vs. external beam radiotherapy alone in pain control of painful bone metastases in breast cancer patients. MATERIALS AND METHODS: Eighty-four patients with painful bone metastases from breast cancer participated in this prospective study. We randomized the patients into two groups: group A treated with radiotherapy 30 Gy in 10 fractions and group B treated with capecitabine 825 mg/m2 every 12 hrs. concurrently with the same radiotherapy dose. RESULTS: There was no statistically significant difference between the two groups regarding early treatment toxicity. Most of the toxicity was gastrointestinal (diarrhea and nausea) and mild (grade I or II). The median pain score decreased from week one, and there was a marked response at week4. The difference in median pain score between both groups was statistically significant with p-value = 0.045. The median analgesic score in both groups was statistically significant with a p-value = 0.032 at week 12. A complete response to pain at week 4 was 19% and 42.9% in groups A and B, respectively. CONCLUSION: Concurrent chemoradiation in painful bone metastases from breast cancer origin was tolerable and safe; it had a higher overall response rate and pain palliation than radiotherapy alone.

Prognostic significance of estrogen, progesterone and HER2 receptors' status conversion following neoadjuvant chemotherapy in patients with locally advanced breast cancer: Results from a tertiary Cancer Center in Saudi Arabia.

BACKGROUND: The prognostic impact of neoadjuvant chemotherapy (NAC) on the receptor expression status in patients with locally advanced breast cancer (LABC) is still not fully understood. We aimed to evaluate the changes in hormone (estrogen and progesterone) receptor (HR) and human epidermal growth factor receptor 2 (HER2) status post-NAC and their correlation with survival. METHODS: Patients with LABC who have received NAC between 2008 and 2015 and have been followed up till December 2019 at the Oncology Center, King Saud University, KSA were analyzed retrospectively. biomarker analysis of ER, PR & HER2 were done using immunohistochemistry (IHC) and Fluorescent in situ hybridization. RESULTS: Ninety-one patients fulfilled the inclusion criteria. HR status changed in 21(23.1%) patients, with a significant difference between patients with stable receptors and those with any receptor conversion; p = 0.000. Five (5.5%) initially HER2 negative tumors became HER2 positive and 10 (11%) initially HER2 positive tumors became HER2 negative after NAC. The difference in HER2 expression level before and after NAC was not statistically significant (p = 0.302). Univariate analysis relating patients' characteristics and 10-years disease-free survival (DFS) showed only significant correlations with the expressions of ER, PR, and any receptor conversion, (ER and/or PR) p< 0.001, p< 0.001, and p = 0.001; respectively. In the univariate analysis, none of the clinicopathological features showed a significant correlation with the OS except for the molecular subtypes P<0.001. CONCLUSIONS: Patients with LABC have significant changes in the ER and PR receptor status following NAC. Post-NAC expressions change of ER and PR (ER and/or PR) are correlated to DFS. Retesting of the hormone receptors should be considered after NAC in Saudi patients with LABC.

Prognostic Significance of HER2 Expression Changes Following Neoadjuvant Chemotherapy in Saudi Patients With Locally Advanced Breast Cancer.

BACKGROUND: Progesterone receptor (PR), estrogen receptor (ER), and human epidermal growth factor receptor 2 (HER2) significantly influence disease prognosis and therapeutic response in patients with breast cancer. Neoadjuvant chemotherapy (NACT) can change the receptor status, affecting the disease characteristics. PATIENTS AND METHODS: A retrospective chart review was carried out at a single tertiary care hospital in Riyadh, Kingdom of Saudi Arabia, from December 2008 to December 2014, where 91 adult female patients diagnosed with locally advanced breast cancer planning to receive NACT were included. Original pathology and surgical histopathology reports were assessed, and patients were followed up to recurrence, death, or until December 2019. An expression for the ER, PR, and HER2 was carried out in pre and post NACT specimens by an experienced pathologist, and all HER2 with 2+ immunohistochemistry was sent for fluorescence in situ hybridization as per American Society of Clinical Oncology guidelines. RESULTS: ER pre- and postoperatively changed from positive to negative in 17.6% of patients and from negative to positive in 1.1% of patients (P < .001). ER status remained stable in 81.3% of patients. PR changed from positive to negative in 13.2% of patients, and from negative to positive in 3.3% of patients (P < .001), whereas it remained stable in 83.5% of patients. HER2 changed from positive to negative in 11% of patients, and from negative to positive in 5.5% of patients (P < .001), and it remained stable in 83.5% of patients. No significant association was found between overall survival and disease-free-survival with HER2 expression change. CONCLUSION: NACT can induce changes in the ER, PR, and HER2 status, which should be evaluated post-NACT to choose the optimal treatment regimens.

A Multicenter Study of the Impact of Body Mass Index (BMI) on the incidence of Pathologic Complete Response (pCR) Among Saudi Patients with locally advanced Breast cancer (LABC) post Neoadjuvant Chemotherapy (NAC).

PURPOSE: Obesity was reported to be a poor prognostic factor for breast cancer. There is a growing evidence of increasing prevalence of obesity among Saudi women across all age groups (44%). Since the prognostic significance of obesity was not studied in Saudi patients with breast cancer, the aim of this study was to evaluate the impact of BMI on pCR in LABC patients post NAC. PATIENTS AND METHODS: This is a retrospective study between May 2005 to July 2010; 246 consecutive female patients who were diagnosed of LABC (Stage II & III) and underwent surgery in three tertiary care centers, representative of the Kingdom of Saudi Arabia (King Saud Medical City, Riyadh; King Abdullah Hospital, Mecca and King Fahad Specialist Hospital, Dammam) were included in this study. All included patients have received NAC (Anthracycline/Taxane based combination chemotherapy and ± Herceptin). Patients who were diagnosed to have stage IV breast cancer due to presence of distant metastasis were excluded. Patients were categorized as normal (BMI <25 kg/m2), overweight (BMI of 25 to <30 kg/m2) and obese (BMI >30 kg/m2). pCR was defined as no invasive cancer in the breast or axillary tissue. Univariate and multivariate analysis were used to evaluate the statistical associations between pCR and BMI with respect to the other previously established prognostic factors, namely age, tumor grade, stage, ER/ PR /Her-2neu status, molecular subtypes, and lympho-vascular invasion (LVI). RESULTS: The median age was 50 years (range 24-68). Molecular subtypes were as follows: luminal A; 23.2%, luminal B; 45.1%, triple negative; 16.7% and Her-2 neu positive; 15%. Infiltrating ductal carcinoma represents the majority of our cohort (92.7%). Eighty-six (35%) were stage II and 160 (65%) were stage III. Intermediate and high-grade malignancies were found in 52% and 44.3% of the patients respectively. Positive lymph vascular invasion was detected in 41.5%. Obese patients constitute 55.7% of our cohort. Pathologic complete response was achieved in 62 patients (25.2%). In Univariate analysis LVI and overweight /obesity were negatively correlated with pCR (P= 0.037 and 0.000 respectively) while tumor grade was positively correlated with pCR (P= 0.008). In multivariate analysis, Overweight/ obesity was the only significant independent factor correlating with pCR (P=0.000). No impact of BMI has been demonstrated on both disease-free survival (DFS) and overall survival (OS) (P=0.93, 0.18 respectively). CONCLUSION: In this study, Overweight/Obesity (which represent more than half of the patients =81.3 %) had a negative impact on pCR in Saudi patients with LABC treated with NAC. This poorer outcome in patients with abnormal weight (Overweight/Obesity) necessitates further prospective studies of this risk factor in order to optimize the care of this group of patients.

A Simple Immunohistochemical Panel Could Predict and Correlate to Clinicopathologic and Molecular Subgroups of Urinary Bladder Urothelial Carcinoma.

BACKGROUND: Although gene expression profiling provided a comprehensive molecular characterization of different subtypes of bladder urothelial carcinoma (UC), which are distinct in their biological features and prognosis, such a system is not yet applicable for routine clinical practice. This study aimed to examine the expression of these molecular classes of UC using simple panel of immunohistochemical markers. MATERIALS AND METHODS: Tissue sections from 192 specimens of UC were stained with FGFR3, CK5, CCNB1, HER-2, and P53. The molecular classes identified were correlated with clinicopathologic characteristics and patient survival. RESULTS: The most frequent class in our cohort was urobasal B (UroB) (44.1%), followed by squamous cell carcinoma-like (SCCL) (22%), genomically unstable (GU) (20.3%), and urobasal A (UroA) (13.6%). Patients with SCCL were significantly younger (P < .0001). Both the SCCL and GU types were of significantly higher histopathologic grade (P < .0001). UroA tumors were mainly of the T1 stage (75%), whereas 61.5% of the SCCL and 58.3% of the GU types were of stage T2 (P < .001). Prognosis was significantly different among groups. The SCCL class showed the lowest overall survival (38.5%; P = .030) and metastasis-free survival (69.2%; P = .017). The best prognosis was for UroA, with an overall survival of 75% and no metastatic events. CONCLUSION: The distribution of UC subtypes in our study was uniquely different from other studies. This simple immunohistochemical panel could be suggested as a clinically applicable tool that has the potential to be used routinely in guiding individualized treatment of UC.

Types of yeasts that cause vulvovaginal candidiasis in chronic users of corticosteroids.

The current study aims to compare between the types of yeasts that cause vulvovaginal candidiasis (VVC) in women using corticosteroid medication compared to nonusers and estimate their sensitivity to available commercial antifungal agents. In a descriptive analytical cross-sectional study, we recruited 41 chronic corticosteroid users diagnosed clinically to have VVC from Women's Health Hospital, Assiut University, Egypt. Forty-seven age-matched women with VVC were recruited as a control group. Full history and clinical examination were performed. Vaginal sterile swab obtained from the vagina of each participant was subjected to direct Gram-stained smear examination as well as a culture on Sabouraud's glucose agar and HiCrome Candida agar. Further identification of the isolates was done using traditional methods. Fifty out of 88 samples (56.8%) were positive in culture including 25 samples (61%) from corticosteroid users group and 25 (53.2%) from noncorticosteroid users with no statistically significant difference (P = .302). The chronic corticosteroid users had more incidence of recurrent VVC as compared to nonusers (65.9% vs 40.4%, respectively) (P = .015). There was a significantly higher rate of non-Candida albicans (NCA) infections in corticosteroid users compared with nonusers (48% vs 20%, respectively) (P = .036). A higher significant difference in resistance of the isolates against clotrimazole (P = .003) and ketoconazole (P = .017) was demonstrated in corticosteroid users compared to nonusers. Thus, chronic corticosteroid use causes frequent attacks of VVC and increases the frequency of infection by NCA strains. Also, it increases resistance to common antifungal agents especially azole group.

Definition of fields margins for palliative radiotherapy of pancreatic carcinoma.

The present study aimed to provide practical guidelines for palliative treatment of advanced carcinoma of the pancreas (CAP) with the 2D technique. Fifteen patients with locally advanced CAP consecutively treated with radiation therapy at the Radiation Oncology Center, Research and Care Foundation 'Giovanni Paolo II' (Campobasso, Italy) underwent computed tomography simulation in supine position. Definition of the clinical target volume (CTV) included the head and body of the pancreas, and the retropancreatic space. The planning target volume was defined by adding a margin of 14 mm to the CTV in the cranio-caudal direction and of 11 mm in radial direction. For each patient, 3 treatment plans were calculated using a cobalt source, 6 MV photons and 15 MV photons (box technique). Beams were drawn using the primary collimators without using multileaf collimators, and progressively optimized in order to respect the minimum dose (Dmin>90%) constraint. Once the final plan was achieved, distances of the fields edges from a set of reference points (bony or duodenal landmarks) were measured. Using this technique, 15 anterior-posterior and postero-anterior (AP-PA) beams and 15 pairs of lateral-lateral (LL) beams were defined for the different patients. Finally, the single minimal AP-PA and LL beams able to include the 15 sets of AP-PA and LL beams were defined. The results of this analysis are reported in tabular form. Guidelines are provided for treatment based on cobalt unit or Linear accelerator (both 6 and 15 MV photons). This study provides information regarding field size and position. A dosimetric study has been planned to identify the dose to be administered with this technique taking into account current dose-volume constraints.

Total mesorectal excision for the treatment of rectal cancer.

INTRODUCTION: In the surgical treatment of rectal cancer, a clear circumferential resection margin and distal resection margin should be obtained. The aim of this study was to determine the morbidity, mortality, survival outcome, and local failure after total mesorectal excision (TME) in the surgical treatment of rectal cancer. METHODS: This retrospective study was conducted on 101 patients treated for rectal cancer using low anterior resection (LAR), abdominoperinial resection (APR), or Hartmaan's technique. In all operative procedures, total mesorectal excisions (TMEs) were done. The patients were treated from November 2000 to April 2011 in the South Egypt Cancer Institute (SECI) of Assuit University (Egypt). Neo-adjuvant therapy was given to those patients with serosalin filtration, lymph node involvement, and sexual and urinary function impairment. Data were analyzed using IBM-SPSS version 21, and survival rates were estimated using the Kaplan-Meier method. RESULTS: One hundred one patients were evaluable (61 males, 40 females). Regarding the operative procedure used, it was: (APR), LAR, Hartmaan's technique in 15.8%, 71.3%, and 12.9% of patients, respectively. Operation-related mortality during the 30 days after surgery was 3%. The operations resulted in morbidity in 25% of the patients, anastomotic site leak in 5.9% of the patients, urinary dysfynction in 9.9% of the patients, and erectile dysfunction in 15.8% of the male patients. Regarding safety margin, the median distances were distal/radial margin, 23/12 mm, distal limit 7 cm. Median lymph nodes harvest 19 nodes. Primary tumor locations were anteriorly 23.8%, laterally 13.9%, posteriorly 38.6%, and circumferential 23.8%. Protective stoma 16.8%. Primary Tumor TNM classification (T1, T2, T3, and T4; 3, 28.7, 55.4, and 12.9%, respectively). Nodes Metastases (N0, N1, and N2; 57.4, 31.7, and 10.9%, respectively). TNM staging (I, II, III, and IV; 15.8, 29.7, 46.5, and 7.9%, respectively). Chemotherapy was administered to 67.3% of the patients. Radiotherapy (short course neoadjuvant, long course neoadjuvant, and adjuvant postoperative used in 33.7, 20.8, and 19.8% of patients, respectively). Survival 5-years CSS was 73% and 5-years RFS 71%. Mean operative time was 213 minutes. The average amount of intraoperative blood loss was 344 mL. CONCLUSION: Total mesorectal excision (TME) represents the gold-standard technique in rectal cancer surgery. It is safe with neoadjuvent chemoradiotherapy and provides both maximal oncological efficiency (local control and long-term survival and maintenance of a good quality of life).

Clinical utility and prognostic significance of measuring troponin I levels in patients presenting to the emergency room with atrial fibrillation.

BACKGROUND: The clinical significance of mildly elevated troponins in patients presenting to the emergency room (ER) with atrial fibrillation (AF) is not well understood. HYPOTHESIS: We hypothesized that mildly elevated troponin in these patients is associated with adverse cardiovascular outcomes. METHODS: In a multi-center, retrospective study, 662 patients with AF were divided into 3 groups based on troponin levels: group 1, mildly elevated; group 2, normal; and group 3, troponin not measured. Primary outcome was the combined endpoint of all-cause mortality and myocardial infarction (MI) at one year. RESULTS: Levels of TnI were measured in 503 (76%) patients. They were elevated in 220 patients (33%, group 1; mean, 0.56 ng/mL), normal in 283 patients (43%, group 2), and not measured in 159 patients (24%, group 3). Significantly more cardiac testing was done at index hospitalization in group 1 (50%) compared with groups 2 and 3 (28% and 29%, P ≤ 0.001) and in the following year (29%, vs 20% and 17%, P = 0.02). Group 1 had more positive tests (62%) compared with groups 2 and 3 (25% and 43%, P ≤ 0.001). Group 1 had a significantly higher occurrence of the primary endpoint (22%, vs 10% and 15%, P = 0.002), driven primarily by a higher incidence of MI in group 1 (7%, vs 1% and 2%, P = 0.001). CONCLUSIONS: Troponin levels are routinely checked in a majority of patients presenting to the emergency department with AF. Even mildly elevated TnI is associated with a greater incidence of coronary artery disease on diagnostic testing and a higher 1-year incidence of MI.

The prevalence and diagnostic significance of eosinophilic pleural effusions: a meta-analysis and systematic review.

BACKGROUND: Eosinophilic pleural effusion (EPE) is defined by an eosinophil count of ≥10% in the pleural fluid and often caused by air or blood in the pleural space. The diagnostic significance of EPEs is still a matter of debate. OBJECTIVE: The objective of this study was to systematically review the medical literature to evaluate the diagnostic significance of EPEs. METHODS: Electronic databases were searched from 1950 to April 2010 to perform a meta-analysis. Data were extracted using standardized forms, and pooled odds ratios with 95% confidence intervals were calculated. A logistic regression analysis was also performed to evaluate the association between the pleural eosinophil counts and the likelihood of underlying causes of EPEs. RESULTS: We identified a total of 687 cases of EPE. The most common cause of EPEs was malignancy (26%) followed by idiopathic (25%) and parapneumonic (13%) effusions. The likelihood of malignancy or tuberculosis was somehow lower in EPEs than in non-EPEs, but the differences were not statistically significant. The prevalence of malignancy was significantly lower in the group of patients that required a pathologic confirmation (21 vs. 30%; p = 0.01). The likelihood of malignancy was inversely correlated with the pleural fluid eosinophil counts. The likelihood of idiopathic effusion was significantly higher in EPEs than in non-EPEs. CONCLUSIONS: Malignancy was the most common cause of EPEs. EPEs appeared to be a negative predictor of malignancy when a pleural fluid eosinophil count was extremely high. EPEs were more likely to be idiopathic as compared with non-EPEs.

Inhaled antibiotic therapy for ventilator-associated tracheobronchitis and ventilator-associated pneumonia: an update.

Ventilator-associated pneumonia (VAP) remains a leading cause of morbidity and mortality in mechanically-ventilated patients in the Intensive Care Unit (ICU). Ventilator-associated tracheobronchitis (VAT) was previously believed to be an intermediate stage between colonization of the lower respiratory tract and VAP. More recent data, however, suggest that VAT may be a separate entity that increases morbidity and mortality, independently of the occurrence of VAP. Some, but not all, patients with VAT progress to develop VAP. Although inhaled antibiotics alone could be effective for the treatment of VAP, the current consensus of opinion favors their role as adjuncts to systemic antimicrobial therapy for VAP. Inhaled antibiotics are increasingly employed for salvage therapy in patients with VAP due to multi-drug resistant Gram-negative bacteria. In contrast to VAP, VAT could be effectively treated with inhaled antibiotic therapy alone or in combination with systemic antimicrobials.