28 research outputs found

    The importance of a second opinion in the diagnosis of Barrett's esophagus: a "real life" study.

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    Background: Barrett's esophagus is a precancerous lesion, and its identification with the early detection of dysplasia is of paramount importance to prevent adenocarcinoma onset. However, there is still debate on the correct pathological identification of Barrett's esophagus (and of associated dysplasia), and most studies have been conducted in an experimental setting. Aims: To assess previous uncertain diagnoses of Barrett's (with and without dysplasia) via a second opinion of an expert pathologist in a real life setting. Patients and methods: Histological sections of 32 suspected Barrett's patients from ten general Pathology units were centralized into one single unit in which an expert pathologist reviewed the slides blindly. Results: Overall, in 78% of cases there was diagnostic discordance; in particular, in 64% of cases the presence of low grade dysplasia was not confirmed. Of interest, 28% of cases with the original diagnosis were reclassified as non-Barrett's. Conclusions: The pathological diagnosis of Barrett's esophagus, especially with regard to the presence of dysplasia, is still misinterpreted, particularly in the setting of general pathology units. Thus, a second opinion from an experienced pathologist may help in the interpretation of the results and in starting appropriate followup programs

    Major discrepancies between what clinical trial registries record and paediatric randomised controlled trials publish

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    Background: Whether information from clinical trial registries (CTRs) and published randomised controlled trial (RCTs) differs remains unknown. Knowing more about discrepancies should alert those who rely on RCTs for medical decision-making to possible dissemination or reporting bias. To provide help in critically appraising research relevant for clinical practice we sought possible discrepancies between what CTRs record and paediatric RCTs actually publish. For this purpose, after identifying six reporting domains including funding, design, and outcomes, we collected data from 20 consecutive RCTs published in a widely read peer-reviewed paediatric journal and cross-checked reported features with those in the corresponding CTRs. Methods: We collected data for 20 unselected, consecutive paediatric RCTs published in a widely read peer-reviewed journal from July to November 2013. To assess discrepancies, two reviewers identified and scored six reporting domains: funding and conflict of interests; sample size, inclusion and exclusion criteria or crossover; primary and secondary outcomes, early study completion, and main outcome reporting. After applying the Critical Appraisal Skills Programme (CASP) checklist, five reviewer pairs cross-checked CTRs and matching RCTs, then mapped and coded the reporting domains and scored combined discrepancy as low, medium and high. Results: The 20 RCTs were registered in five different CTRs. Even though the 20 RCTs fulfilled the CASP general criteria for assessing internal validity, 19 clinical trials had medium or high combined discrepancy scores for what the 20 RCTs reported and the matched five CTRs stated. All 20 RCTs selectively reported or failed to report main outcomes, 9 had discrepancies in declaring sponsorship, 8 discrepancies in the sample size, 9 failed to respect inclusion or exclusion criteria, 11 downgraded or modified primary outcome or upgraded secondary outcomes, and 13 completed early without justification. The CTRs for seven trials failed to index automatically the URL address or the RCT reference, and for 12 recorded RCT details, but the authors failed to report the results. Conclusions: Major discrepancies between what CTRs record and paediatric RCTs publish raise concern about what clinical trials conclude. Our findings should make clinicians, who rely on RCT results for medical decision-making, aware of dissemination or reporting bias. Trialists need to bring CTR data and reported protocols into line with published data

    The importance of a second opinion in the diagnosis of Barrett’s esophagus: a “real life” study

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    Background: Barrett's esophagus is a precancerous lesion, and its identification with the early detection of dysplasia is of paramount importance to prevent adenocarcinoma onset. However, there is still debate on the correct pathological identification of Barrett's esophagus (and of associated dysplasia), and most studies have been conducted in an experimental setting. Aims: To assess previous uncertain diagnoses of Barrett's (with and without dysplasia) via a second opinion of an expert pathologist in a real life setting. Patients and methods: Histological sections of 32 suspected Barrett's patients from ten general Pathology units were centralized into one single unit in which an expert pathologist reviewed the slides blindly. Results: Overall, in 78% of cases there was diagnostic discordance; in particular, in 64% of cases the presence of low grade dysplasia was not confirmed. Of interest, 28% of cases with the original diagnosis were reclassified as non-Barrett's. Conclusions: The pathological diagnosis of Barrett's esophagus, especially with regard to the presence of dysplasia, is still misinterpreted, particularly in the setting of general pathology units. Thus, a second opinion from an experienced pathologist may help in the interpretation of the results and in starting appropriate followup programs

    The importance of a second opinion in the diagnosis of Barrett's esophagus: a "real life" study

    No full text
    Background: Barrett's esophagus is a precancerous lesion, and its identification with the early detection of dysplasia is of paramount importance to prevent adenocarcinoma onset. However, there is still debate on the correct pathological identification of Barrett's esophagus (and of associated dysplasia), and most studies have been conducted in an experimental setting. Aims: To assess previous uncertain diagnoses of Barrett's (with and without dysplasia) via a second opinion of an expert pathologist in a real life setting. Patients and methods: Histological sections of 32 suspected Barrett's patients from ten general Pathology units were centralized into one single unit in which an expert pathologist reviewed the slides blindly. Results: Overall, in 78% of cases there was diagnostic discordance; in particular, in 64% of cases the presence of low grade dysplasia was not confirmed. Of interest, 28% of cases with the original diagnosis were reclassified as non-Barrett's. Conclusions: The pathological diagnosis of Barrett's esophagus, especially with regard to the presence of dysplasia, is still misinterpreted, particularly in the setting of general pathology units. Thus, a second opinion from an experienced pathologist may help in the interpretation of the results and in starting appropriate follow-up programs

    Accuracy of visual on-site evaluation (Vose) In predicting the adequacy of Eus-guided fine needle biopsy: a single center prospective study

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    Objective: Endoscopic ultrasound is the standard procedure for the diagnosis of pancreatic lesions and new needles have been developed to improve tissue acquisition (FNB). Rapid onset evaluation (ROSE) decreases the number of needle passes but is not always available. We introduced an easy and rapid method of direct classification of EUS-FNB sample namely Visual on-site evaluation (VOSE). Aims: To assess the accuracy of VOSE in predicting the histological adequacy of specimens. To evaluate the diagnostic power of FNB and the rate of core tissue obtained. Methods: Prospective single center study on patients with pancreatic lesions that underwent EUS-FNB. VOSE parameters were presence of blood, macroscopic visible core (MVC), number, color and length of specimen. The association between VOSE tool and histological adequacy was assessed. Fisher's exact test and Student's t-test used to compare categorical and continuous variables. Logistic regression analysis was used to assess association between variables. Results: 99 patients (58.6% male; mean age 68.4 ± 10) enrolled, including 102 lesions. Total number of passes was 358 with median number of 4 (range, 2-4). The 92.7% of samples were adequate and it was higher with the 22-G needle than with 25G (96.5% vs 89.2% p 0.01). VOSE "red-mixed specimen" was associated with a higher probability of histological adequacy (OR 2.39 95% CI 1.03-5.42 p = 0.04). Conclusions: The VOSE tool "red-mixed specimen" can be used to predict the histological adequacy and guide the number of needle passes. Overall, FNB provides a high rate of adequate and diagnostic specimen and high rate of core tissue especially with the 22G needle

    Complications in pediatric endoscopy

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    The experience of the “endoscopic community” in pediatric patients is limited, but during recent years increased skills of the endoscopists and technological improvements lead to a standardization of pediatric endoscopy and the development of specialized pediatric endoscopy unit. Adverse events related to diagnostic and therapeutic endoscopy in children are usually rare. Diagnosis, prevention and treatment of complications in pediatric endoscopy is crucial when dealing with benign diseases in children. The complication rate of diagnostic EGD and colonoscopy in children are extremely low. Therapeutic procedures have obviously an increased rate of adverse events. Esophageal dilations are the most common indication for endoscopic therapy in children and can lead to perforations which requires prompt diagnosis and management. Complications of ERCP in pediatric age are similar to those reported in adults. The experience in pediatric emergency endoscopy (mainly foreign body removal) is consolidated and related adverse events extremely rare. Sedation of children during endoscopy maybe needs further evaluation and standardization, to reduce the rate of specific complications

    A pilot study assessing tolerance safety and feasibility of diagnostic transnasal esophagogastroduodenoscopy using an improved larger caliber endoscope and an adapted topical anesthesia

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    Background: Transnasal esophagogastroduodenoscopy (TN-EGDS) is well tolerated by patients and the examination is perceived comfortable without the need of a sedative drug. Conversely, mainly in Western literature, some authors report limitations in illumination, image quality, and working channel as affecting TN-EGDS diffusion. To overcome these disadvantages, a new transnasal endoscope (TNE) was tested but, due to its larger diameter, we have no evidence of its clinical safety and tolerability. A new adapted nasal anesthesia could be useful to improve TNE tolerance. In an independent, not sponsored, pilot prospective study we enrolled, in a busy clinical hospital setting, 30 adult patients receiving nasal atomized Lidocaine and Xylometazoline (XAL) to undergo a diagnostic TN-EGDS with TNE to evaluate its tolerance, safety, and feasibility. Methods: Three physicians enrolled inpatients and outpatients with indication to diagnostic EGDS during a 6-month period. Main outcome measures were cardio-pulmonary monitoring data and patients’ answers to an adapted questionnaire investigating pain, anxiety level, willingness to repeat the examination, operators’ scores about endoscopy quality, examination conduction and anesthesia-related complications. Results: The examination was completed by the transnasal route in 100 % of the enrolled patients, endoscopy satisfaction and feasibility were scored to nearly the highest levels by the three different physicians. A total of 29/30 patients (96.6 %) declared the willingness to repeat the same examination if needed. The mean patients’ score for overall pain was 3.7 ± 1 SD (range 1–10 by Visual Analog Scale). Mean endoscopy duration was 11.1 ± 2.6 min (range 5.0–19.0). In a total of 17/30 TN-EGDS that lasted more than 11 min, higher heart frequency variations and worse tolerance scores were found (p < 0.05). Conclusion: Our pilot study demonstrates that TN-EGDS with TNE and NA is safe, well tolerated, and feasible. The best clinical tolerance is reached when TN-EGDS lasts <11 min

    Feasibility of EUS-guided Nd:YAG laser ablation of unresectable pancreatic adenocarcinoma

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    Background and Aims: EUS has become an interventional technique in which a needle may be used as a vehicle to deliver therapeutic agents. Laser ablation (LA) has been used to treat many primary and secondary neoplasms. This study aimed to assess the feasibility of EUS-guided LA for unresectable (UR) pancreatic cancer. Methods: Patients with stage IIb-III pancreatic cancer underwent EUS-guided LA. All patients were unresponsive to previous chemoradiotherapy. LA was performed by using a 300-ÎĽm flexible fiber preloaded onto a 22-gauge fine needle. A 1064-nm wavelength neodymium-yttrium aluminum garnet (Nd:YAG) laser light with different power settings of 2 W for 800 J, 1000 J, and 1200 J; 3 W for 800 J, 1000 J, and 1200 J; and 4 W for 800 J, 1000 J, and 1200 J was used. Each patient was treated with a single application of 1 of these settings. The application time of the power settings ranged from 200 to 600 seconds. Results: Nine patients (median age, 74.7; range 55-85) underwent Nd:Yag LA. The mean size of the focal lesion was 35.4 mm (range, 21-45). The ablation area, demonstrated by 24-hour CT, ranged from.4 cm3(for the lower power setting of 2 W/800 J) to a maximum of 6.4 cm3(for 4 W/1000 J). The procedure was completed in all 9 patients without adverse events. Conclusion: In our human experience, EUS-guided LA was feasible and well tolerated in patients with UR pancreatic cancer

    An uncommon cause of abdominal pain in a child: Meckel diverticulum

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    Meckel diverticulum, a common congenital anomaly of the small intestine, can be responsible of several complications due to the presence of ectopic gastric mucosa and represents a challenge for diagnosis. We present the case of a 11-year boy suffering from intestinal pain and bleeding in which radiological examinations unexpectedly raised the suspicion of Meckel diverticulum. The diagnosis was confirmed using 99mTc-pertechnetate scintigraphy. At surgery, a fistulous tract between Meckel diverticulum and an inflamed appendix was found. The authors discuss the role of medical nuclear imaging which, notwithstanding its limitations, is of fundamental importance to achieve a correct and timely diagnosis. This is of particular relevance in unusual cases, as the one presented, in which Meckel diverticulum is found concurrently with other intestinal abnormalities
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