Risk to human health associated with the environmental occurrence of cyanobacterial neurotoxic alkaloids anatoxins and saxitoxins

Cyanobacteria are ubiquitous photosynthetic micro-organisms forming blooms and scums in surface water; among them some species can produce cyanotoxins giving rise to some concern for human health and animal life. To date, more than 65 cyanobacterial neurotoxins have been described, of which the most studied are the groups of anatoxins and saxitoxins (STXs), comprising many different variants. In freshwaters, the hepatotoxic microcystins represent the most frequently detected cyanotoxin: on this basis, it could appear that neurotoxins are less relevant, but the low frequency of detection may partially reflect an a priori choice of target analytes, the low method sensitivity and the lack of certified standards. Cyanobacterial neurotoxins target cholinergic synapses or voltage-gated ion channels, blocking skeletal and respiratory muscles, thus leading to death by respiratory failure. This review reports and analyzes the available literature data on environmental occurrence of cyanobacterial neurotoxic alkaloids, namely anatoxins and STXs, their biosynthesis, toxicology and epidemiology, derivation of guidance values and action limits. These data are used as the basis to assess the risk posed to human health, identify critical exposure scenarios and highlight the major data gaps and research needs.     

Reports of Large Immunosuppression Trials in Kidney Transplantation: Room for Improvement

The reporting quality of publications of clinical trials can affect the quality of clinical decision-making. We systematically assessed the quality of publications of large multicenter trials evaluating immunosuppressive regimens in de novo kidney transplantation. Study quality, reporting quality and accessibility of the results of 63 publications were assessed independently by three blinded investigators using an instrument combining the Jadad scale with a list of reporting quality items. Study quality was rated with an average of only 2.3 (range 1-5) on the Jadad scale. Unblinded studies were reported in 68.3% of publications and follow-up longer than 12 months was reported for only 13 out of 50 studies. The reviewed publications fulfilled an average of 69.1% of the reporting quality criteria. Fifty-four percent of publications did not report both treated and biopsy-proven rejections. Whether reported graft survival was censored for death could not be determined for 27% of publications. Only a few publications gave confidence intervals (CIs) or stated whether additional analyses were pre-specified. Even the largest trials of immunosuppression in kidney transplantation show considerable quality deficits in their design and publication. Additional efforts are required of investigators, editors and sponsors to achieve maximum study and reporting quality.     

Preventing seroma formation after axillary dissection for breast cancer: a randomized clinical trial

BackgroundSeroma formation after axillary dissection remains the most common early sequel to breast cancer surgery. Different surgical approaches have been performed to reduce seroma collection. Therefore, we aimed to assess the outcome of patients operated on using an ultrasound scalpel according to a standardized operative technique before accepting it as a routine procedure.MethodsA randomized controlled trial was designed to compare the outcome of patients undergoing breast surgery and axillary dissection using either standard scalpel blades, scissors, ligations, and electrocautery or the ultrasound scalpel only. Each arm of the trial consisted of 30 patients.ResultsA statistically significant benefit in terms of axillary and chest wall drainage volume, the number of axilla seromas, intraoperative bleeding, and hospitalization stay was recorded in the harmonic scalpel group. No significant differences were found between the 2 groups in terms of operative time. Finally, no postoperative hematoma, wound infections, and chest wall seroma were observed.ConclusionsThe use of the harmonic scalpel was shown to reduce the magnitude of seromas in axilla and hospitalization stay. The harmonic scalpel can be used alone in axillary dissection with a safe and effective hemostasis. Our results must be confirmed by larger series.     

Sentinel Lymph Node Biopsy Versus Axillary Dissection in Node-Negative Early-Stage Breast Cancer: 15-Year Follow-Up Update of a Randomized Clinical Trial

Background

Sentinel lymph node biopsy (SLNB) allows for staging of the axillary node status in early-stage breast cancer (BC) patients and avoiding complete axillary lymph node dissection (ALND) when the sentinel lymph node (SLN) is proven to be free of disease. In a previous randomized trial we compared SLNB followed by ALND (ALND arm) with SLNB followed by ALND only if the SLN presented metastasis (SLNB arm). At a mid-term of ≈ 6 years median follow-up, the two strategies appeared to ensure similar survival and locoregional control. We have revised these previous findings and update the results following a 15-year observation period.

Methods

Patients were randomly assigned to either the ALND or SLNB arm. The main endpoints were event-free survival (EFS), overall survival (OS), and axillary disease recurrence. EFS and OS were assessed using Kaplan–Meier analysis and the log-rank test.

Results

The ALND and SLNB arms included 115 and 110 patients, respectively. At 14.3 years median follow-up, 39 primary BC-related recurrences occurred, 22 (19 %) of which occurred in the ALND arm and 17 (16 %) occurred in the SLNB arm (p = 0.519). No axillary relapse developed in the SLNB arm, while two were observed in the ALND arm. OS (82.0 vs. 78.8 %) and EFS (72.8 vs. 72.9 %) were not statistically different between the ALND and SLNB arms (p = 0.502 and 0.953, respectively).

Conclusions

SLNB is a safe and efficacious component of the surgical treatment of early-stage BC patients. In the long-term, SLNB is equivalent to ALND in terms of locoregional nodal disease control and survival in this subset of patients.

     

Colitis cystica profunda of the rectum: report of a case and review of the literature

Colitis cystica profunda is a rare intestinal lesion. Because of its clinical expression (rectorrhagia, mucorrhea and abdominal pain) and the way it appears to current imaging techniques this disease presents features which can be associated with colon neoplasm. Its diagnosis has to be confirmed histologically, and its etiology remains unclear. The following is a case report of colitis cystica profunda recurring 20 years after a first episode in a white woman, who had had an anterior resection of the sigmoid colon and upper rectum to deal with a colitis cystica profunda-induced stenosis of the sigmoid colon and at 41 underwent the transanal removal of a polypoid lesion. A review of 20 cases in the literature showed that colitis cystica profunda has a predilection for the male and generally affects the medial and lower rectum and the sigmoid colon. The literature also confirmed the association with ulcerative rectocolitis, Crohn's disease and rectal prolapse. The type of treatment varies from surgical, medical, and endoscopic to no treatment at all.     

F-18-fluorodeoxyglucose positron emission tomography in differentiating malignant from benign pancreatic cysts: A prospective study

The differential diagnosis between benign and malignant pancreatic cystic lesions may be very difficult. We recently found that F-18-.uorodeoxyglucose positron emission tomography (18-FDG PET) was useful for the preoperative work-up of pancreatic cystic lesions. This study was undertaken to confirm these results. From February 2000 to July 2003, 50 patients with a pancreatic cystic lesion were prospectively investigated with 18-FDG PET in addition to helical computed tomography (CT) and, in some instances, magnetic resonance imaging (MRI). The validation of diagnosis was based on pathologic findings after surgery (n = 31), percutaneous biopsy (n = 4), and according to follow-up in 15 patients. The 18-FDG PET was analyzed visually and semiquantitatively using the standard uptake value (SUV). The accuracy of FDG PET and CT was determined for preoperative diagnosis of malignant cystic lesions. Seventeen patients had malignant cystic lesions. Sixteen (94%) showed increased 18-FDG uptake (SUV >2.5), including two patients with carcinoma in situ. Eleven patients (65%) were correctly identified as having malignancy by CT. Thirty-three patients had benign tumors: two patients showed increased 18-FDG uptake, and four patients showed CT findings of malignancy. Sensitivity, specificity, positive and negative predictive value, and accuracy of 18-FDG PET and CT in detecting malignant tumors were 94%, 94%, 89%, 97%, and 94% and 65%, 88%, 73%, 83%, and 80%, respectively. 18-FDG PET is accurate in identifying malignant pancreatic cystic lesions and should be used in combination with CT in the preoperative evaluation of patients with pancreatic cystic lesions. A negative result with 18-FDG PET may avoid unnecessary operation in asymptomatic or high-risk patients. Presented at the Forty-Fifth Annual Meeting of The Society for Surgery of the Alimentary Tract, New Orleans, Louisiana, May 15–19, 2004 (oral presentation). This study was supported by the Ministero Università e Ricerca Scientifica (Cofin 2001068593-001), Rome, Italy.     

Complete surgical resection of a huge thoracic mass consisting in a localized fibrous tumor simulating a high-grade malignant neoplasm

Solitary fibrous tumour is an infrequent neoplasm generally arising from the parietal and visceral pleura. The diagnosis may be difficult in the presence of a history of malignant disease owing to the different presentations and to radiological findings of evident invasiveness. The authors report the case of a woman with a right giant fibrous solitary tumour of the pleura twenty years after a subcutaneous mastectomy with axillary dissection and radiation therapy for breast cancer. The biopsy diagnosis was consistent with a probable solitary fibrous tumour of the pleura but the discrepancy with the radiological images and the difficult differential diagnosis versus a malignant sarcoma, possibly radio-induced, prompted us to verify the real features of the disease. The patient was submitted to a right anterolateral thoracotomy and partial sternotomy and the giant mass was resected enbloc with the phrenic nerve and diaphragm which proved to be the only structures tightly adhering to the neoplasm. Histological examination confirmed the diagnosis of a solitary fibrous tumour of the pleura. The patient is still alive and disease-free 30 months after the surgical operation. Fibrous solitary tumour is a disease generally characterised by a good prognosis but in particular cases, with unmistakable radiological findings of invasiveness, a precise diagnosis must be obtained in order to choose the most appropriate therapy.     

Value of 18-Fluorodeoxyglucose Positron Emission Tomography in the Management of Patients With Cystic Tumors of the Pancreas

OBJECTIVE: To assess the reliability of 18-fluorodeoxyglucose positron emission tomography (18-FDG PET) in distinguishing benign from malignant cystic lesions of the pancreas. SUMMARY BACKGROUND DATA: The preoperative differential diagnosis of cystic lesions of the pancreas remains difficult: the most important point is to identify malignant or premalignant cysts that require resection. 18-FDG PET is a new imaging procedure based on the increased glucose metabolism by tumor cells and has been proposed for the diagnosis and staging of pancreatic cancer. METHODS: During a 4-year period, 56 patients with a suspected cystic tumor of the pancreas underwent 18-FDG PET in addition to computed tomography scanning, serum CA 19-9 assay, and in some instances magnetic resonance imaging or endoscopic retrograde cholangiopancreatography. The 18-FDG PET was analyzed visually and semiquantitatively using the standard uptake value. The accuracy of 18-FDG PET and computed tomography was determined for preoperative diagnosis of a malignant cyst. RESULTS: Seventeen patients had malignant tumors. Sixteen patients (94%) showed 18-FDG uptake with a standard uptake value of 2.6 to 12.0. Twelve patients (70%) were correctly identified as having malignancy by computed tomography, CA 19-9 assay, or both. Thirty-nine patients had benign tumors: only one mucinous cystadenoma showed increased 18-FDG uptake (standard uptake value 2.6). Five patients with benign cysts showed computed tomography findings of malignancy. Sensitivity, specificity, and positive and negative predictive values for 18-FDG PET and computed tomography scanning in detecting malignant tumors were 94%, 97%, 94%, and 97% and 65%, 87%, 69%, and 85%, respectively. CONCLUSIONS: 18-FDG PET is more accurate than computed tomography in identifying malignant pancreatic cystic lesions and should be used, in combination with computed tomography and tumor markers assay, in the preoperative evaluation of patients with pancreatic cystic lesions. A positive result on 18-FDG PET strongly suggests malignancy and, therefore, a need for resection; a negative result shows a benign tumor that may be treated with limited resection or, in selected high-risk patients, with biopsy, follow-up, or both.