36 research outputs found

    Mvasi on ensimmäinen bevasitsumabin biosimilaari

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    Ajankohtaista lääkealalla huhtikuussa

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    Triggering factors in non-traumatic intracerebral hemorrhage

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    Background: In ischemic stroke and subarachnoid hemorrhage, there are known preceding triggering events that predispose to the stroke by, for example, abruptly raising blood pressure. We explored, whether triggering events can be identified in non-traumatic intracerebral hemorrhage (ICH). Methods: We used structured questionnaires to interview consented patients with ICH treated in a tertiary teaching hospital, between 2014 and 2016. We asked of possible trigger factors, including Valsalva-inducing activity, heavy physical exertion, sexual activity, abrupt change in position, a heavy meal, a sudden change in temperature, exposure to traffic jam, and the combination of the first three (any physical trigger) during the hazard period of 0-2 h prior to ICH. The ratio of the reported trigger during the hazard period was compared to the same 2-h period the previous day (control period) to calculate the relative risks for each factor (case-crossover design). Results: Of our 216 consented ICH patients, 97 (35.0%) could be interviewed for trigger questions. Reasons for not able to provide consistent and reliable responses included lowered level of consciousness, delirium, impaired memory, and aphasia. None of the studied possible triggers alone were more frequent during the hazard period compared to the control period. However, when all physical triggers were combined, we found an association with the triggering event and onset of ICH (risk ratio 1.32, 95% confidence interval 1.01-1.73). Conclusions: Obtaining reliable information on the preceding events before ICH onset was challenging. However, we found that physical triggers as a group were associated with the onset of ICH.Peer reviewe

    Ajankohtaista lääkealalla syyskuussa

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    Effect of Hydrocortisone vs Pasireotide on Pancreatic Surgery Complications in Patients With High Risk of Pancreatic Fistula A Randomized Clinical Trial

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    Importance Both hydrocortisone and pasireotide have been shown in randomized clinical trials to be effective in reducing postoperative complications of pancreatic surgery, but to date no randomized clinical trial has evaluated the effectiveness of pasireotide compared with hydrocortisone. Objective To assess the noninferiority of hydrocortisone compared with pasireotide in reducing complications after partial pancreatectomy. Design, Setting, and Participants A noninferiority, parallel-group, individually randomized clinical trial was conducted at a single academic center between May 19, 2016, and December 17, 2018. Outcome collectors and analyzers were blinded. A total of 281 patients undergoing partial pancreatectomy were assessed for inclusion. Patients younger than 18 years, those allergic to hydrocortisone or pasireotide, patients undergoing pancreaticoduodenectomy with hard pancreas or dilated pancreatic duct, and patients not eventually undergoing partial pancreatectomy were excluded. Modified intention-to-treat analysis was used in determination of the results. Interventions Treatment included pasireotide, 900 mu g, subcutaneously twice a day for 7 days or hydrocortisone, 100 mg, intravenously 3 times a day for 3 days. Main Outcomes and Measures The primary outcome was the Comprehensive Complication Index (CCI) score within 30 days. The noninferiority limit was set to 9 CCI points. Results Of the 281 patients (mean [SD] age, 63.8 years) assessed for eligibility, 168 patients (mean [SD] age, 63.6 years) were randomized and 126 were included in the modified intention-to-treat analyses. Sixty-three patients received pasireotide (35 men [56%]; median [interquartile range] age, 64 [56-70] years) and 63 patients received hydrocortisone (25 men [40%]; median [interquartile range] age, 67 [56-73] years). The mean (SD) CCI score was 23.94 (17.06) in the pasireotide group and 30.11 (20.47) in the hydrocortisone group (mean difference, -6.16; 2-sided 90% CI, -11.73 to -0.60), indicating that hydrocortisone was not noninferior. Postoperative pancreatic fistula was detected in 34 patients (54%) in the pasireotide group and 39 patients (62%) in the hydrocortisone group (odds ratio, 1.39; 95% CI, 0.68-2.82; P = .37). One patient in the pasireotide group and 2 patients in the hydrocortisone group died within 30 days. In subgroup analyses of patients undergoing distal pancreatectomy, the CCI score was a mean of 10.3 points lower (mean [SD], 16.03 [11.94] vs 26.28 [21.76]; 2-sided 95% CI, -19.34 to -2.12; P = .03) and postoperative pancreatic fistula rate was lower (37% vs 67%; P = .02) in the pasireotide group compared with the hydrocortisone group. Conclusions and Relevance In this study, hydrocortisone was not noninferior compared with pasireotide in patients undergoing partial pancreatectomy. Pasireotide may be more effective than hydrocortisone in patients undergoing distal pancreatectomy.Peer reviewe

    Prediction and consequences of postoperative pancreatitis after pancreaticoduodenectomy

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    In this retrospective cohort study, 18 per cent of 508 patients undergoing pancreaticoduodenectomy had clinically relevant postoperative pancreatitis, which increased the overall morbidity of these patients. The available and validated fistula risk scores can also be used to predict the risk of postoperative pancreatitis. Background Recent studies have suggested postoperative acute pancreatitis (POAP) as a serious complication after pancreaticoduodenectomy (PD) and have speculated on its possible role in the pathogenesis of postoperative pancreatic fistula (POPF). This study aimed to assess the impact of POAP on post-PD outcomes and fistula risk score (FRS) performance in predicting POAP. Methods All PDs at Helsinki University Hospital between 2013 and 2020 were analysed. POAP was defined as a plasma amylase activity greater than the normal upper limit on postoperative day (POD) 1 and stratified as clinically relevant (CR)-POAP once C-reactive protein (CRP) reached or exceeded 180 mg/l, and non-CR-POAP once CRP was less than 180 mg/l on POD 2. The Comprehensive Complication Index (CCI) was used to assess total postoperative morbidity. Different FRSs were assessed using receiver operating characteristic curves. Results Of the 508 patients included, POAP occurred in 202 (39.8 per cent) patients, of whom 91 (17.9 per cent) had CR-POAP. The incidence of CR-POPF was 12.6 per cent (64 patients). Patients with non-CR-POAP had a similar morbidity to patients with no POAP (median CCI score 24.2 versus 22.6; P = 0.142), while CCI score was significantly higher (37.2) in patients with CR-POAP (P < 0.001). CR-POAP was associated with increased rates of CR-POPF, delayed gastric emptying, haemorrhage, and bile leak, while non-CR-POAP was associated only with CR-POPF. Ninety-day mortality was 1.6 per cent, 0.9 per cent, and 3.3 per cent in patients with no-POAP, non-CR-POAP, and CR-POAP, respectively. Updated alternative FRS showed the best performance in predicting CR-POAP (area under the curve 0.834). Conclusion CR-POAP was associated with a higher CCI score, suggesting CR-POAP as a distinct entity from non-CR-POAP. FRSs can be used to assess the risk of CR-POAP.Peer reviewe

    The critical view of safety and bile duct injuries in laparoscopic cholecystectomy : a photo evaluation study on 1532 patients

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    Background: Laparoscopic cholecystectomy (LCC) carries a 0.3-1.8% risk of bile duct injury (BDI). This study investigated if intraoperative photo documentation of the critical view of safety (CVS) is related to lower rates of BDIs and postoperative complications in LCC. Methods: Surgeons were instructed to take photos of the view before clipping the cystic duct and artery. Two independent raters scored the photos 0-6 using predefined criteria for CVS. Mean scores of >= 4.5 were satisfactory. Results: The study consisted of 1532 patients undergoing LCC between April 2018 and October 2019. CVS was satisfactory in 354 (23.1%), unsatisfactory in 823 (53.7%), and photos were missing in 355 (23.2%) patients. Patients with satisfactory CVS had the lowest BDI rate compared with unsatisfactory CVS or missing photos (0.3% vs. 1.0% vs. 2.3%, p = 0.012). Four major BDIs (Strasberg D-E) occurred, but none in patients with satisfactory CVS. Patients with satisfactory CVS had the lowest postoperative complication rate compared with patients with unsatisfactory CVS or without photos (4.8% vs. 7.9 vs. 9.9%, p = 0.011). Of patients with acute cholecystitis, 15.7% had satisfactory CVS, whereas 26.8% without cholecystitis had satisfactory CVS (p < 0.001). Conclusion: Intraoperative photo documentation of satisfactory CVS is associated with lower rates of BDIs and complications.Peer reviewe

    Three-dimensional versus two-dimensional high-definition laparoscopy in cholecystectomy: a prospective randomized controlled study

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    While 3D laparoscopy increases surgical performance under laboratory conditions, it is unclear whether it improves outcomes in real clinical scenarios. The aim of this trial was to determine whether the 3D laparoscopy can enhance surgical efficacy in laparoscopic cholecystectomy (LCC).Peer reviewe

    Development and external validation of DISPAIR fistula risk score for clinically relevant postoperative pancreatic fistula risk after distal pancreatectomy

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    This study describes the development and external validation of the DISPAIR score, a preoperative clinical prediction model to estimate the risk of postoperative pancreatic fistula after distal pancreatectomy. It is based on three variables measured before operation: pancreatic thickness, transection site, and history of diabetes. On external validation, it showed satisfactory discrimination (area under the curve 0.80) and calibration (slope 0.719, intercept 0.192) for predicting pancreatic fistula. Background Highly utilized risk scores for clinically relevant postoperative pancreatic fistula (CR-POPF) have guided clinical decision-making in pancreatoduodenectomy. However, none has been successfully developed for distal pancreatectomy. This study aimed to develop and validate a new fistula risk score for distal pancreatectomy. Methods Patients undergoing distal pancreatectomy at Helsinki University Hospital, Finland from 2013 to 2021, and at Karolinska University Hospital, Sweden, from 2010 to 2020, were included retrospectively. The outcome was CR-POPF, according to the 2016 International Study Group of Pancreatic Surgery definition. Preoperative clinical demographics and radiological parameters such as pancreatic thickness and duct diameter were measured. A logistic regression model was developed, internally validated with bootstrapping, and the performance assessed in an external validation cohort. Results Of 668 patients from Helsinki (266) and Stockholm (402), 173 (25.9 per cent) developed CR-POPF. The final model consisted of three variables assessed before surgery: transection site (neck versus body/tail), pancreatic thickness at transection site, and diabetes. The model had an area under the receiver operating characteristic curve (AUROC) of 0.904 (95 per cent c.i. 0.855 to 0.949) after internal validation, and 0.798 (0.748 to 0.848) after external validation. The calibration slope and intercept on external validation were 0.719 and 0.192 respectively. Four risk groups were defined in the validation cohort for clinical applicability: low (below 5 per cent), moderate (at least 5 but below 30 per cent), high (at least 30 but below 75 per cent), and extreme (75 per cent or more). The incidences in these groups were 8.7 per cent (11 of 126), 22.0 per cent (36 of 164), 63 per cent (57 of 91), and 81 per cent (17 of 21) respectively. Conclusion The DISPAIR score after distal pancreatectomy may guide decision-making and allow a risk-adjusted outcome comparison for CR-POPF.Peer reviewe
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