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OBJECTIVE: Contaminated duodenoscopes caused several hospital outbreaks. Despite efforts to reduce contamination rates, 15% of patient-ready duodenoscopes are still contaminated with gastrointestinal microorganisms. This study aimed to provide an overview of duodenoscope contamination over time, identify risk factors and study the effects of implemented interventions. DESIGN: Duodenoscope culture sets between March 2015 and June 2022 at a Dutch tertiary care centre were analysed. Contamination was defined as (1) the presence of microorganisms of oral or gastrointestinal origin (MGO) or (2) any other microorganism with ≥20 colony-forming units/20 mL (AM20). A logistic mixed effects model was used to identify risk factors and assess the effect of interventions, such as using duodenoscopes with disposable caps, replacing automated endoscope reprocessors (AER) and conducting audits in the endoscopy department. RESULTS: A total of 404 culture sets were analysed. The yearly contamination rate with MGO showed great variation, ranging from 14.3% to 47.5%. Contamination with AM20 increased up to 94.7% by 2022. For both MGO and AM20, the biopsy and suction channels were the most frequently contaminated duodenoscope components. The studied interventions, including audits, AER replacement and implementation of duodenoscopes with disposable caps, did not show a clear association with contamination rates. CONCLUSION: Duodenoscope contamination remains a significant problem, with high contamination rates despite several interventions. Reprocessing the biopsy and suction channels is especially challenging. Changes in the design of reusable duodenoscopes, such as enabling sterilisation or easily replaceable channels, are necessary to facilitate effective duodenoscope reprocessing and to eliminate the risk of duodenoscope-associated infections.
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Infecção Hospitalar , Duodenoscópios , Humanos , Colangiopancreatografia Retrógrada Endoscópica , Infecção Hospitalar/prevenção & controle , Infecção Hospitalar/epidemiologia , Óxido de Magnésio , Estudos Retrospectivos , Centros de Atenção TerciáriaRESUMO
OBJECTIVE: To describe the long-term consequences of necrotising pancreatitis, including complications, the need for interventions and the quality of life. DESIGN: Long-term follow-up of a prospective multicentre cohort of 373 necrotising pancreatitis patients (2005-2008) was performed. Patients were prospectively evaluated and received questionnaires. Readmissions (ie, for recurrent or chronic pancreatitis), interventions, pancreatic insufficiency and quality of life were compared between initial treatment groups: conservative, endoscopic/percutaneous drainage alone and necrosectomy. Associations of patient and disease characteristics during index admission with outcomes during follow-up were assessed. RESULTS: During a median follow-up of 13.5 years (range 12-15.5 years), 97/373 patients (26%) were readmitted for recurrent pancreatitis. Endoscopic or percutaneous drainage was performed in 47/373 patients (13%), of whom 21/47 patients (45%) were initially treated conservatively. Pancreatic necrosectomy or pancreatic surgery was performed in 31/373 patients (8%), without differences between treatment groups. Endocrine insufficiency (126/373 patients; 34%) and exocrine insufficiency (90/373 patients; 38%), developed less often following conservative treatment (p<0.001 and p=0.016, respectively). Quality of life scores did not differ between groups. Pancreatic gland necrosis >50% during initial admission was associated with percutaneous/endoscopic drainage (OR 4.3 (95% CI 1.5 to 12.2)), pancreatic surgery (OR 3.2 (95% CI 1.1 to 9.5) and development of endocrine insufficiency (OR13.1 (95% CI 5.3 to 32.0) and exocrine insufficiency (OR6.1 (95% CI 2.4 to 15.5) during follow-up. CONCLUSION: Acute necrotising pancreatitis carries a substantial disease burden during long-term follow-up in terms of recurrent disease, the necessity for interventions and development of pancreatic insufficiency, even when treated conservatively during the index admission. Extensive (>50%) pancreatic parenchymal necrosis seems to be an important predictor of interventions and complications during follow-up.
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Insuficiência Pancreática Exócrina , Pancreatite Necrosante Aguda , Pancreatite Crônica , Humanos , Pancreatite Necrosante Aguda/complicações , Pancreatite Necrosante Aguda/cirurgia , Seguimentos , Qualidade de Vida , Estudos Prospectivos , Insuficiência Pancreática Exócrina/etiologia , Pancreatite Crônica/complicações , Drenagem/efeitos adversos , Necrose , Resultado do TratamentoRESUMO
BACKGROUND AND AIMS: Obtaining adequate tissue samples in subepithelial lesions (SELs) remains challenging. Several biopsy techniques are available, but a systematic review including all available techniques to obtain a histologic diagnosis of SEL is lacking. The aim of this study was to evaluate the diagnostic yield and adverse event rates of endoscopic biopsies, EUS-guided FNA (EUS-FNA), EUS-guided fine-needle biopsy (FNB) (EUS-FNB), and mucosal incision-assisted biopsy (MIAB) for SELs in the upper GI tract. METHODS: A search strategy in multiple databases was performed. The primary outcome was diagnostic yield, defined as the percentage of procedures in which histology was obtained and resulted in a definitive histopathologic diagnosis. Secondary outcome measures included reported procedure-related adverse events, which were graded according to the AGREE (Adverse Events in Gastrointestinal Endoscopy) classification. RESULTS: A total of 94 original articles were included. Studies were classified per endoscopic technique to obtain histopathology. This resulted in 8 included studies for endoscopic biopsy methods, 55 studies for EUS-FNA, 33 studies for EUS-FNB, and 26 studies for MIAB. Pooled rates for diagnostic yield were 40.6% (95% confidence interval [CI], 30.8-51.2) for endoscopic biopsy, 74.6% (95% CI, 69.9-78.7) for EUS-FNA, 84.2% (95% CI, 80.7-87.2) for EUS-FNB, and 88.2% (95% CI, 84.7-91.1) for MIAB. Reported procedure-related adverse events graded AGREE II or higher were 2.8% to 3.9% for endoscopic biopsies, 1.0% to 4.5% for EUS-FNA, .9% to 7.7% for EUS-FNB, and 1.9% to 7.9% for MIAB. CONCLUSIONS: Based on the available evidence, MIAB and EUS-FNB seem to be most effective in terms of achieving a high diagnostic yield, with similar rates of adverse events.
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Aspiração por Agulha Fina Guiada por Ultrassom Endoscópico , Humanos , Aspiração por Agulha Fina Guiada por Ultrassom Endoscópico/métodos , Aspiração por Agulha Fina Guiada por Ultrassom Endoscópico/efeitos adversos , Endossonografia/métodos , Endoscopia Gastrointestinal/métodos , Neoplasias Gastrointestinais/patologia , Neoplasias Gastrointestinais/diagnóstico , Neoplasias Gástricas/patologia , Neoplasias Gástricas/diagnóstico , Trato Gastrointestinal Superior/patologia , Biópsia Guiada por Imagem/métodos , Biópsia Guiada por Imagem/efeitos adversos , Neoplasias Esofágicas/patologia , Neoplasias Esofágicas/diagnósticoRESUMO
BACKGROUND AND AIMS: Periodic duodenoscope cultures are essential to timely detect contamination, but their sensitivity remains unknown. This study aims to determine the sensitivity of duodenoscope cultures and to estimate the prevalence of contaminated duodenoscope use. METHODS: We combined duodenoscope microbiological surveillance data from March 2015 to June 2022 with usage data to evaluate patient exposure to duodenoscopes contaminated with microorganisms of gut or oral origin (MGO). We identified duodenoscopes with repeated species-level contamination within a year and used molecular typing to confirm genetic relatedness. Genetically related microorganisms over multiple duodenoscope cultures of a single duodenoscope indicated a period of sustained contamination and a cluster was defined as overlapping periods of sustained contamination between different duodenoscopes. If microorganisms were not available for molecular analysis, we marked the period as unconfirmed. A sample was defined as false-negative if it did not show the target microorganism(s) in a period of sustained contamination. We used three scenarios to hypothesize about contaminated use and culture sensitivity. RESULTS: We included 556 duodenoscope cultures with 185 (33.3%) contaminated with MGO. The total usage of duodenoscopes was 5226. We identified one period of sustained contamination, six unconfirmed periods, and two clusters. Depending on our scenario assumptions, the percentage of contaminated use varied from 12.3% to 23.7%, and culture sensitivity ranged from 82.2% to 98.9%. CONCLUSIONS: Limited sensitivity of duodenoscope cultures leads to improper clearance of duodenoscopes for clinical use, increasing risks of outbreaks. The applicability of a single culture to end a duodenoscope's quarantine should be reevaluated.
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BACKGROUND: Endoscopic transmural drainage (ETD) using double-pigtail stents (DPSs) is a well-established treatment for walled-off pancreatic necrosis (WON). This study aimed to compare outcomes in patients undergoing ETD with DPSs left indwelling versus those where stents were removed or migrated. METHODS: This retrospective multicenter cohort study included patients with WON who underwent ETD using DPSs between July 2001 and December 2019. The primary outcome was recurrence of a pancreatic fluid collection (PFC). Secondary outcomes were long-term complications and recurrence-associated factors. Competing risk regression analysis considered DPS removal or migration as time-varying covariates. RESULTS: Among 320 patients (median age 58; 36% women), DPSs were removed in 153 (47.8%), migrated spontaneously in 27 (8.4%), and remained indwelling in 140 (43.8%). PFC recurrence was observed in 57 patients (17.8%): after removal (n = 39; 25.5%); after migration (n = 4; 14.8%); in patients with indwelling DPSs (n = 14; 10.0%). In 25 patients (7.8%), drainage of recurrent PFC was indicated. Risk factors for recurrence were DPS removal or migration (hazard ratio [HR] 3.45, 95%CI 1.37-8.70) and presence of a disconnected pancreatic duct (HR 5.08, 95%CI 1.84-14.0). CONCLUSIONS: Among patients who undergo ETD of WON, leaving DPSs in situ seems to lower the risk of recurrent fluid collections, without any long-term DPS-related complications. These results suggest that DPSs should not be routinely removed and can be safely left indwelling indefinitely.
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Biliary complications are common after liver transplantation (LT). Endoscopic retrograde cholangiopancreatography (ERCP) is the preferred method to treat biliary complications. Nevertheless, ERCP is not without complications and may have a greater complication rate in the LT population. Knowledge of the prevalence, severity, and possible risk factors for post-ERCP pancreatitis (PEP) in LT recipients is limited. Therefore, this study aims to determine the incidence and severity of PEP and identify potential risk factors in LT recipients. This retrospective cohort included patients ≥18 years who underwent ≥1 ERCP procedures after LT between January 2010 and October 2021. Two hundred thirty-two patients were included, who underwent 260 LTs and 1125 ERCPs. PEP occurred after 23 ERCP procedures (2%) with subsequent mortality in three (13%). Multivariate logistic regression identified wire cannulation of the pancreatic duct as a significant risk factor for PEP (OR, 3.21). The complication rate of PEP after LT in this study was shown to be low and is lower compared to patients without a history of LT. Nevertheless, the mortality rate of this group of patients was notably higher.
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Colangiopancreatografia Retrógrada Endoscópica , Transplante de Fígado , Pancreatite , Complicações Pós-Operatórias , Humanos , Colangiopancreatografia Retrógrada Endoscópica/efeitos adversos , Transplante de Fígado/efeitos adversos , Masculino , Feminino , Estudos Retrospectivos , Pessoa de Meia-Idade , Fatores de Risco , Pancreatite/etiologia , Complicações Pós-Operatórias/etiologia , Seguimentos , Prognóstico , Incidência , Adulto , Taxa de Sobrevida , IdosoRESUMO
PURPOSE: This study aims to elucidate the association between MRI measurements of spine alterations and self-reported outcomes of pain and disability in individuals with non-specific low back pain, using a comprehensive perspective based on machine learning algorithm. METHODS: 246 consecutive subjects were assessed. Pain severity in cervical, lumbar, and leg regions was determined using visual analogue scale, and functional disability was acquired by Oswestry Disability Index. Sagittal and axial MRI scans of the thoracolumbar spine were evaluated. Severity of disc degeneration, spinal canal stenosis, and presence of vertebral endplate lesions based on two different classification schemes involving the extent and the shape of defects were quantified at the levels from T12L1 to L5S1. The following parameters describing the lumbar region as a whole were calculated: maximum value along spinal levels, sum of values along levels, number of levels characterized by severe condition. The association with pain and disability was assessed by generalized multiple linear regression modelling. RESULTS: Disc degeneration was identified as a predictor of disability and partially of pain, whereas canal stenosis was found associated with changes in pain in the leg region. Partial correlation values ranged from 0.11 to 0.32. Endplate lesions did not show significant associations. CONCLUSION: A partial association between MRI measurements and self-reported outcomes of pain and disability was confirmed. Disc degeneration was the most correlated with the reported indexes, while canal stenosis mainly affected the pain levels in the leg region. The presence of endplate lesions did not demonstrate any significant relationships.
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INTRODUCTION: Our objective was to assess abnormalities of the odontoid-hip axis (OD-HA) angle in a mild scoliotic population to determine whether screening for malalignment would help predict the distinction between progressive and stable adolescent idiopathic scoliosis (AIS) at early stage. MATERIALS AND METHODS: All patients (non-scoliotic and AIS) underwent a biplanar X-ray between 2013 and 2020. In AIS, inclusion criteria were Cobb angle between 10° and 25°; Risser sign lower than 3; age higher than 10 years; and no previous treatment. A 3D spine reconstruction was performed, and the OD-HA was computed automatically. A reference corridor for OD-HA values in non-scoliotic subjects was calculated as the range [5th-95th percentiles]. A severity index, helping to distinguish stable and progressive AIS, was calculated and weighted according to the OD-HA value. RESULTS: Eighty-three non-scoliotic and 205 AIS were included. The mean coronal and sagittal OD-HA angles in the non-scoliotic group were 0.2° and -2.5°, whereas in AIS values were 0.3° and -0.8°, respectively. For coronal and sagittal OD-HA, 27.5% and 26.8% of AIS were outside the reference corridor compared with 10.8% in non-scoliotic (OR = 3.1 and 3). Adding to the severity index a weighting factor based on coronal OD-HA, for thoracic scoliosis, improved the positive predictive value by 9% and the specificity by 13%. CONCLUSION: Analysis of OD-HA suggests that AIS patients are almost three times more likely to have malalignment compared with a non-scoliotic population. Furthermore, analysis of coronal OD-HA is promising to help the clinician distinguish between stable and progressive thoracic scoliosis.
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Cifose , Escoliose , Humanos , Adolescente , Criança , Escoliose/diagnóstico por imagem , Escoliose/cirurgia , Estudos Longitudinais , Cifose/diagnóstico por imagem , Estudos de Coortes , Radiografia , Estudos RetrospectivosRESUMO
Distinguishing syngenetic from protogenetic inclusions in natural diamonds is one of the most debated issues in diamond research. Were the minerals that now reside in inclusions in diamonds born before the diamond that hosts them (protogenesis)? Or did they grow simultaneously and by the same reaction (syngenesis)? Once previously published data on periclase [(Mg,Fe)O] and magnesiochromite (MgCr2O4) inclusions in diamond have been re-analysed, we show that the main arguments reported so far to support syngenesis between diamond and its mineral inclusions, definitely failed. Hence: (a) the epitaxial relationships between diamond and its mineral inclusion should no longer be used to support syngenesis, because only detecting an epitaxy does not tell us which was the nucleation substrate (there are evidences that in case of epitaxy, the inclusion acts as a nucleation substrate); (b) the morphology of the inclusion should no longer be used as well, as inclusions could be protogenetic regardless their shapes. Finally, we advance the hypothesis that the majority of inclusions in diamonds are protogenetic, e.g., they are constituent of rocks in which diamonds were formed and not products of reactions during diamond growth.
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Individuals at high risk of developing pancreatic ductal adenocarcinoma are eligible for surveillance within research programs. These programs employ periodic imaging in the form of magnetic resonance imaging/magnetic resonance cholangiopancreatography or endoscopic ultrasound for the detection of early cancer or high-grade precursor lesions. This narrative review discusses the role of endoscopic ultrasound within these surveillance programs. It details its overall strengths and limitations, yield, burden on patients, and how it compares to magnetic resonance imaging. Finally, recommendations are given when and how to incorporate endoscopic ultrasound in the surveillance of high-risk individuals.
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Carcinoma Ductal Pancreático , Endossonografia , Neoplasias Pancreáticas , Humanos , Endossonografia/métodos , Neoplasias Pancreáticas/diagnóstico por imagem , Carcinoma Ductal Pancreático/diagnóstico por imagem , Carcinoma Ductal Pancreático/patologia , Detecção Precoce de Câncer/métodos , Imageamento por Ressonância Magnética/métodos , Colangiopancreatografia por Ressonância Magnética/métodosRESUMO
Background and study aims Histological confirmation of subepithelial lesions (SELs) in the upper gastrointestinal tract remains challenging. Endoscopic resection of SELs is increasingly used for its excellent diagnostic yield and opportunity to do away with continued surveillance. In this study, we aimed to evaluate the indications, success rates and complications of different endoscopic resection techniques for SELs at a large, tertiary referral hospital in Rotterdam, The Netherlands. Patients and methods Data between October 2013 and December 2021 were retrospectively collected and analyzed. Main outcomes were R0-resection rate, en bloc resection rate, recurrence rate, and procedure-related adverse events (AEs) (Clavien-Dindo). Secondary outcomes were procedure time, need for surgical intervention, and clinical impact on patient management. Results A total of 58 patients were referred for endoscopic resection of upper gastrointestinal SELs. The median diameter of lesions was 20 mm (range 7-100 mm). Median follow-up time was 5 months (range 0.4-75.7). Forty-eight procedures (83%) were completed successfully leading to en bloc resection in 85% and R0-resection in 63%. Procedure-related AEs occurred in six patients (13%). Severe complications (CD grade 3a) were seen in three patients. The local recurrence rate for (pre)malignant diagnosis was 2%. Additional surgical intervention was needed in seven patients (15%). A total of 32 patients (67%) could be discharged from further surveillance after endoscopic resection. Conclusions Endoscopic resection is a safe and effective treatment for SELs and offers valuable information about undetermined SELs for which repeated sampling attempts have failed to provide adequate tissue for diagnosis.
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Endoscopic ultrasound (EUS) with fine needle aspiration or fine needle biopsy is the gold standard for sampling tissue to diagnose pancreatic cancer and autoimmune pancreatitis or to analyze cyst fluid. The most common reported adverse event of fine needle aspiration and/or fine needle biopsy is acute pancreatitis, which is likely induced by the same pathophysiological mechanisms as after endoscopic retrograde cholangiopancreatography (ERCP). According to the current European Society of Gastrointestinal Endoscopy guideline, nonsteroidal anti-inflammatory drugs are administered prior to ERCP as a scientifically proven treatment to reduce post-ERCP pancreatitis incidence rate. A single suppository of diclofenac or indomethacin prior to EUS guided tissue acquisition (TA) is harmless in healthy adults. Since it is associated with low costs and, most important, may prevent a dreadsome complication, we strongly recommend the administration of 100 mg diclofenac rectally prior to EUS-TA. We will explain this recommendation in more detail in this review as well as the risk and pathophysiology of post-EUS TA pancreatitis.
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Pancreatite , Adulto , Humanos , Pancreatite/epidemiologia , Pancreatite/etiologia , Pancreatite/prevenção & controle , Incidência , Diclofenaco/uso terapêutico , Doença Aguda , Anti-Inflamatórios não Esteroides/uso terapêutico , Colangiopancreatografia Retrógrada Endoscópica/efeitos adversos , Ultrassonografia de Intervenção/efeitos adversos , Aspiração por Agulha Fina Guiada por Ultrassom Endoscópico/efeitos adversosRESUMO
Background and study aims Reprocessing reusable endoscopes is challenging due to their non-sterilizable nature. Disinfection has been shown to have a significant risk of failure with serious consequences. Single-use endoscopes can eliminate contamination risk and reduce workflow delays caused by reprocessing. This study evaluated the clinical performance of single-use gastroscopes in patients undergoing esophagogastroduodenoscopy (EGD). Patients and methods In this case series, 60 patients underwent EGD using single-use gastroscopes, with 34 procedures in the endoscopy department and 26 in the intensive care unit. The primary outcome was successful completion of the intended EGD objective. Furthermore, certified endoscopists assessed device performance on a five-point Likert scale (ranging from 1-"much worse" to 5-"much better"), considering their experience with a reusable gastroscope. Results Successful completion of EGDs using only the single-use gastroscope was achieved in 58 of 60 cases (96.7%). In two cases, crossover to an ultra-slim endoscope was necessary to either reach the esophageal stenosis or to transverse the stenosis. Overall satisfaction was rated as comparable to reusable scopes in 51 of 56 cases (91.1%) and inferior in five cases (8.9%). The lower weight of the single-use gastroscope was rated as superior in 42 of 60 cases (70.0%). Drawbacks included reduced image quality (23 of 45 cases; 51.1%). Feedback included the absence of a freeze button, lens cleaning issues, and small image size. Conclusions Single-use gastroscopes exhibited a high EGD completion rate and effectiveness for various indications. Further research should focus on evaluating the implementation of single-use gastroscopes in a comprehensive context, considering clinical effectiveness, costs, and environmental impact.
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Studies have revealed anthropometric discrepancies in girls with adolescent idiopathic scoliosis (AIS) compared to non-scoliotic subjects, such as a higher stature, lower weight, and lower body mass index. While the causes are still unknown, it was proposed that metabolic hormones could play a role in AIS pathophysiology. Our objectives were to evaluate the association of GLP1R A316T polymorphism in AIS susceptibility and to study its relationship with disease severity and progression. We performed a retrospective case-control association study with controls and AIS patients from an Italian and French Canadian cohort. The GLP1R rs10305492 polymorphism was genotyped in 1025 subjects (313 non-scoliotic controls and 712 AIS patients) using a validated TaqMan allelic discrimination assay. Associations were evaluated by odds ratio and 95% confidence intervals. In the AIS group, there was a higher frequency of the variant genotype A/G (4.2% vs. 1.3%, OR = 3.40, p = 0.016) and allele A (2.1% vs. 0.6%, OR = 3.35, p = 0.017) than controls. When the AIS group was stratified for severity (≤40° vs. >40°), progression of the disease (progressor vs. non-progressor), curve type, or body mass index, there was no statistically significant difference in the distribution of the polymorphism. Our results support that the GLP1R A316T polymorphism is associated with a higher risk of developing AIS, but without being associated with disease severity and progression.
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Receptor do Peptídeo Semelhante ao Glucagon 1 , Polimorfismo de Nucleotídeo Único , Escoliose , Humanos , Escoliose/genética , Feminino , Adolescente , Itália/epidemiologia , Masculino , Receptor do Peptídeo Semelhante ao Glucagon 1/genética , Estudos de Casos e Controles , Predisposição Genética para Doença , Canadá/epidemiologia , Estudos Retrospectivos , Criança , MutaçãoRESUMO
BACKGROUND: Postoperative cholangitis is a common complication after pancreatoduodenectomy that can occur with or without anatomical biliary obstruction. This study aimed to investigate the incidence, diagnosis, treatment, and risk factors of cholangitis after pancreatoduodenectomy. METHODS: We performed a retrospective cohort study of consecutive patients who underwent pancreatoduodenectomy in 2 Dutch tertiary pancreatic centers (2010-2019). Primary outcome was postoperative cholangitis, defined as systemic inflammation with abnormal liver tests without another focus of infection, at least 1 month after resection. Diagnostic and therapeutic strategies were evaluated. Two types of postoperative cholangitis were distinguished; obstructive cholangitis (benign stenosis of the hepaticojejunostomy) and nonobstructive cholangitis. Potential risk factors were identified using logistic regression analysis. RESULTS: Postoperative cholangitis occurred in 93 of 900 patients (10.3%). Median time to first episode of cholangitis was 8 months (interquartile range 4-16) after pancreatoduodenectomy. Multiple episodes of cholangitis occurred in 44 patients (47.3%) and readmission was necessary in 83 patients (89.2%). No cholangitis-related mortality was observed. Obstructive cholangitis was seen in 37 patients (39.8%) and nonobstructive cholangitis in 56 patients (60.2%). Surgery was performed for cholangitis in 7 patients (7.5%) and consisted of revision of the hepaticojejunostomy or elongation of the biliary limb. Postoperative biliary leakage (odds ratio 2.56; 95% confidence interval 1.42-4.62; P = .0018) was independently associated with postoperative cholangitis. CONCLUSION: Postoperative cholangitis unrelated to cancer recurrence was seen in 10% of patients after pancreatoduodenectomy. Nonobstructive cholangitis was more common than obstructive cholangitis. Postoperative biliary leakage was an independent risk factor.
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INTRODUCTION: Refractory pain is a major clinical problem in patients with pancreatic ductal adenocarcinoma (PDAC) and chronic pancreatitis (CP). New, effective therapies to reduce pain are urgently needed. Intravenous lidocaine is used in clinical practice in patients with PDAC and CP, but its efficacy has not been studied prospectively. METHODS: Multicentre prospective non-randomized pilot study including patients with moderate or severe pain (NRS ≥ 4) associated with PDAC or CP in 5 Dutch centers. An intravenous lidocaine bolus of 1.5mg/kg, was followed by continuous infusion at 1.5 mg/kg/hour. The dose was raised every 15 minutes until treatment response (up to a maximum 2mg/kg/hour) and consecutively administered for two hours. Primary outcome was the mean difference in pain severity, pre-infusion and the first day after (Brief Pain Inventory [BPI] scale 1-10). A BPI decrease ≥ 1.3 points was considered clinically relevant. RESULTS: Overall, 30 patients were included, 19 with PDAC (63%) and 11 with CP (37%). The mean difference in BPI at day one was 1.1 (SD±1.3) points for patients with PDAC and 0.5 (SD±1.7) for CP patients. A clinically relevant decrease in BPI on day one was reported in 9/29 patients (31%), this response lasted up to one month. No serious complications were reported, and only three minor complications (vertigo, nausea, tingling of mouth). Treatment with lidocaine did not impact quality of life. CONCLUSION: Intravenous lidocaine in patients with painful PDAC and CP did not show an overall clinically relevant reduction of pain. However, this pilot study shows that the treatment is feasible in this patient group, and had a positive effect in a third of patients which lasted up to a month with only minor side effects. To prove or exclude the efficacy of intravenous lidocaine, the study should be performed in a study with a greater sample size and less heterogeneous patient group.
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BACKGROUND: Mesenteric artery stenting with a bare-metal stent is the current treatment for atherosclerotic chronic mesenteric ischaemia. Long-term patency of bare-metal stents is unsatisfactory due to in-stent intimal hyperplasia. Use of covered stents might improve long-term patency. We aimed to compare the patency of covered stents and bare-metal stents in patients with chronic mesenteric ischaemia. METHODS: We conducted a multicentre, patient-blinded and investigator-blinded, randomised controlled trial including patients with chronic mesenteric ischaemia undergoing mesenteric artery stenting. Six centres in the Netherlands participated in this study, including two national chronic mesenteric ischaemia expert centres. Patients aged 18 years or older were eligible for inclusion when an endovascular mesenteric artery revascularisation was scheduled and a consensus diagnosis of chronic mesenteric ischaemia was made by a multidisciplinary team of gastroenterologists, interventional radiologists, and vascular surgeons. Exclusion criteria were stenosis length of 25 mm or greater, stenosis caused by median arcuate ligament syndrome or vasculitis, contraindication for CT angiography, or previous target vessel revascularisation. Digital 1:1 block randomisation with block sizes of four or six and stratification by inclusion centre was used to allocate patients to undergo stenting with bare-metal stents or covered stents at the start of the procedure. Patients, physicians performing follow-up, investigators, and radiologists were masked to treatment allocation. Interventionalists performing the procedure were not masked. The primary study outcome was the primary patency of covered stents and bare-metal stents at 24 months of follow-up, evaluated in the modified intention-to-treat population, in which stents with missing data for the outcome were excluded. Loss of primary patency was defined as the performance of a re-intervention to preserve patency, or 75% or greater luminal surface area reduction of the target vessel. CT angiography was performed at 6 months, 12 months, and 24 months post intervention to assess patency. The study is registered with ClinicalTrials.gov (NCT02428582) and is complete. FINDINGS: Between April 6, 2015, and March 11, 2019, 158 eligible patients underwent mesenteric artery stenting procedures, of whom 94 patients (with 128 stents) provided consent and were included in the study. 47 patients (62 stents) were assigned to the covered stents group (median age 69·0 years [IQR 63·0-76·5], 28 [60%] female) and 47 patients (66 stents) were assigned to the bare-metal stents group (median age 70·0 years [63·5-76·5], 33 [70%] female). At 24 months, the primary patency of covered stents (42 [81%] of 52 stents) was superior to that of bare-metal stents (26 [49%] of 53; odds ratio [OR] 4·4 [95% CI 1·8-10·5]; p<0·0001). A procedure-related adverse event occurred in 17 (36%) of 47 patients in the covered stents group versus nine (19%) of 47 in the bare-metal stent group (OR 2·4 [95% CI 0·9-6·3]; p=0·065). Most adverse events were related to the access site, including haematoma (five [11%] in the covered stents group vs six [13%] in the bare-metal stents group), pseudoaneurysm (five [11%] vs two [4%]), radial artery thrombosis (one [2%] vs none), and intravascular closure device (none vs one [2%]). Six (13%) patients in the covered stent group versus one (2%) in the bare-metal stent group had procedure-related adverse events not related to the access site, including stent luxation (three [6%] vs none), major bleeding (two (4%) vs none), mesenteric artery perforation (one [2%] vs one [2%]), mesenteric artery dissection (one [2%] vs one [2%]), and death (one [2%] vs none). INTERPRETATION: The findings of this trial support the use of covered stents for mesenteric artery stenting in patients with chronic mesenteric ischaemia. FUNDING: Atrium Maquet Getinge Group.
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Aterosclerose , Isquemia Mesentérica , Humanos , Feminino , Idoso , Masculino , Isquemia Mesentérica/cirurgia , Constrição Patológica/etiologia , Stents/efeitos adversos , Artérias MesentéricasRESUMO
BACKGROUND: The dynamics of Staphylococcus aureus in patients and the hospital environment are relatively unknown. We studied these dynamics in a tertiary care hospital in the Netherlands. METHODS: Nasal samples were taken from adult patients at admission and discharge. Isolates cultured from clinical samples taken before and during hospitalization from these patients were included. Environmental samples of patient rooms were taken over a three-year period. Finally, isolates from clinical samples from patients with an epidemiological link to S. aureus positive rooms were included. Staphylococcal protein A (spa) typing was performed. RESULTS: Nasal samples were taken from 673 patients. One hundred eighteen (17.5%) were positive at admission and discharge, 15 (2.2%) patients acquired S. aureus during hospitalization. Nineteen patients had a positive clinical sample during hospitalization, 15.9% of the S. aureus were considered as from an exogenous source. One hundred and forty (2.8%) environmental samples were S. aureus positive. No persistent contamination of surfaces was observed. Isolates were highly diverse: spa typing was performed for 893 isolates, identifying 278 different spa types, 161 of these spa types were observed only once. CONCLUSION: Limited transmission could be identified between patients and the hospital environment, and from patient-to-patient. Exogenous acquisition was assumed to occur in 15% of clinical samples. Environmental contamination was infrequent, temporarily, and coincided with the strain from the patient admitted to the room at that time. MRSA was rare and not found in the environment.