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Gastro-oEsophageal Cancers (GECs) are severe diseases whose management is rapidly evolving. The European Society of Surgical Oncology (ESSO) is committed to the generation and spread of knowledge, and promotes the multidisciplinary management of cancer patients through its core curriculum. The present work discusses the approach to GECs, including the management of oligometastatic oesophagogastric cancers (OMEC), the diagnosis and management of peritoneal metastases from gastric cancer (GC), the management of Siewert Type II tumors, the importance of mesogastric excision, the role of robotic surgery, textbook outcomes, organ preserving options, the use of molecular markers and immune check-point inhibitors in the management of patients with GECs, as well as the improvement of current clinical practice guidelines for the management of patients with GECs. The aim of the present review is to provide a concise overview of the state-of-the-art on the management of patients with GECs and, at the same time, to share the latest advancements in the field and to foster the debate between surgical oncologists treating GECs worldwide. We are sure that our work will, at the same time, give an update to the advanced surgical oncologists and help the training surgical oncologists to settle down the foundations for their future practice.
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Neoplasias Esofágicas , Procedimientos Quirúrgicos Robotizados , Neoplasias Gástricas , Humanos , Neoplasias Gástricas/terapia , Neoplasias Gástricas/patología , Neoplasias Esofágicas/terapia , Neoplasias Esofágicas/patología , Procedimientos Quirúrgicos Robotizados/educación , Neoplasias Peritoneales/secundario , Neoplasias Peritoneales/terapia , Oncología Quirúrgica/educación , Curriculum , Inhibidores de Puntos de Control Inmunológico/uso terapéutico , Europa (Continente) , Tratamientos Conservadores del Órgano , Sociedades MédicasRESUMEN
BACKGROUND: Unnecessary D2-gastrectomy and associated costs can be prevented after detecting non-curable gastric cancer, but impact of staging on treatment costs is unclear. This study determined the cost impact of 18F-fluorodeoxyglucose positron emission tomography/computed tomography (18FFDG-PET/CT) and staging laparoscopy (SL) in gastric cancer staging. MATERIALS AND METHODS: In this cost analysis, four staging strategies were modeled in a decision tree: (1) 18FFDG-PET/CT first, then SL, (2) SL only, (3) 18FFDG-PET/CT only, and (4) neither SL nor 18FFDG-PET/CT. Costs were assessed on the basis of the prospective PLASTIC-study, which evaluated adding 18FFDG-PET/CT and SL to staging advanced gastric cancer (cT3-4 and/or cN+) in 18 Dutch hospitals. The Dutch Healthcare Authority provided 18FFDG-PET/CT unit costs. SL unit costs were calculated bottom-up. Gastrectomy-associated costs were collected with hospital claim data until 30 days postoperatively. Uncertainty was assessed in a probabilistic sensitivity analysis (1000 iterations). RESULTS: 18FFDG-PET/CT costs were 1104 including biopsy/cytology. Bottom-up calculations totaled 1537 per SL. D2-gastrectomy costs were 19,308. Total costs per patient were 18,137 for strategy 1, 17,079 for strategy 2, and 19,805 for strategy 3. If all patients undergo gastrectomy, total costs were 18,959 per patient (strategy 4). Performing SL only reduced costs by 1880 per patient. Adding 18FFDG-PET/CT to SL increased costs by 1058 per patient; IQR 870-1253 in the sensitivity analysis. CONCLUSIONS: For advanced gastric cancer, performing SL resulted in substantial cost savings by reducing unnecessary gastrectomies. In contrast, routine 18FFDG-PET/CT increased costs without substantially reducing unnecessary gastrectomies, and is not recommended due to limited impact with major costs. TRIAL REGISTRATION: NCT03208621. This trial was registered prospectively on 30-06-2017.
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Fluorodesoxiglucosa F18 , Gastrectomía , Laparoscopía , Estadificación de Neoplasias , Tomografía Computarizada por Tomografía de Emisión de Positrones , Radiofármacos , Neoplasias Gástricas , Neoplasias Gástricas/patología , Neoplasias Gástricas/cirugía , Neoplasias Gástricas/diagnóstico por imagen , Neoplasias Gástricas/economía , Humanos , Laparoscopía/economía , Laparoscopía/métodos , Tomografía Computarizada por Tomografía de Emisión de Positrones/economía , Tomografía Computarizada por Tomografía de Emisión de Positrones/métodos , Estudios Prospectivos , Gastrectomía/economía , Fluorodesoxiglucosa F18/economía , Radiofármacos/economía , Análisis Costo-Beneficio , Estudios de Seguimiento , Pronóstico , Costos y Análisis de Costo , Masculino , FemeninoRESUMEN
INTRODUCTION: Patients with a first venous thromboembolism (VTE) are at risk of recurrence. Recurrent VTE (rVTE) can be prevented by extended anticoagulant therapy, but this comes at the cost of an increased risk of bleeding. It is still uncertain whether patients with an intermediate recurrence risk or with a high recurrence and high bleeding risk will benefit from extended anticoagulant treatment, and whether a strategy where anticoagulant duration is tailored on the predicted risks of rVTE and bleeding can improve outcomes. The aim of the Leiden Thrombosis Recurrence Risk Prevention (L-TRRiP) study is to evaluate the outcomes of tailored duration of long-term anticoagulant treatment based on individualised assessment of rVTE and major bleeding risks. METHODS AND ANALYSIS: The L-TRRiP study is a multicentre, open-label, cohort-based, randomised controlled trial, including patients with a first VTE. We classify the risk of rVTE and major bleeding using the L-TRRiP and VTE-BLEED scores, respectively. After 3 months of anticoagulant therapy, patients with a low rVTE risk will discontinue anticoagulant treatment, patients with a high rVTE and low bleeding risk will continue anticoagulant treatment, whereas all other patients will be randomised to continue or discontinue anticoagulant treatment. All patients will be followed up for at least 2 years. Inclusion will continue until the randomised group consists of 608 patients; we estimate to include 1600 patients in total. The primary outcome is the combined incidence of rVTE and major bleeding in the randomised group after 2 years of follow-up. Secondary outcomes include the incidence of rVTE and major bleeding, functional outcomes, quality of life and cost-effectiveness in all patients. ETHICS AND DISSEMINATION: The protocol was approved by the Medical Research Ethics Committee Leiden-Den Haag-Delft. Results are expected in 2028 and will be disseminated through peer-reviewed journals and during (inter)national conferences. TRIAL REGISTRATION NUMBER: NCT06087952.
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Trombosis , Tromboembolia Venosa , Humanos , Anticoagulantes/efectos adversos , Hemorragia/inducido químicamente , Hemorragia/complicaciones , Estudios Multicéntricos como Asunto , Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como Asunto , Recurrencia , Tromboembolia Venosa/etiologíaRESUMEN
The predominant approach to understand dynamic risk factors of sexual reoffending has been referred to as the Propensities Model (Thornton, 2016). According to this model, dynamic risk factors can be conceptualized as latent constructs whose change alters the risk of sexual reoffending. Despite its strengths and contributions to research, this model does not offer answers to the question of how dynamic risk factors contribute to the risk of sexual reoffending, or of how sustained change in risk might take place. In this paper we introduce the Network-Based Model of Risk of Sexual Reoffending (NBM-RSR), which addresses several limitations and constraints of the Propensities Model and offers empirically testable propositions regarding the nature and development of the risk of sexual reoffending. The NBM-RSR considers risk of sexual reoffending to involve a self-sustaining network of causally connected dynamic risk factors. Consistent with this, an increased risk of sexual reoffending is characterized through a network that contains more and stronger interconnected dynamic risk factors with a higher strength. Sustained change in risk of sexual reoffending occurs when activity in the network exceeds a critical point resulting in a new self-sustaining network. Propositions based on the NBM-RSR are introduced and translated into testable hypotheses. These propositions revolve around (a) risk of sexual reoffending resulting from the construction of a network of causally connected dynamic risk factors, (b) network stability, sudden changes, and critical transitions, and (c) dynamic risk factors' relative influence on risk of sexual reoffending.
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Delitos Sexuales , Adulto , Masculino , Humanos , Factores de Riesgo , Medición de RiesgoRESUMEN
Background: Current guidelines on the management of chronic cough do not provide recommendations for the operation of specialist cough clinics. The objective of the present study was to develop expert consensus on goals and standard procedures for specialist cough clinics. Methods: We undertook a modified Delphi process, whereby initial statements proposed by experts were categorised and presented back to panellists over two ranking rounds using an 11-point Likert scale to identify consensus. Results: An international panel of 57 experts from 19 countries participated, with consensus reached on 15 out of 16 statements, covering the aims, roles and standard procedures of specialist cough clinics. Panellists agreed that specialist cough clinics offer optimal care for patients with chronic cough. They also agreed that history taking should enquire as to cough triggers, cough severity rating scales should be routinely used, and a minimum of chest radiography, spirometry and measurements of type 2 inflammatory markers should be undertaken in newly referred patients. The importance of specialist cough clinics in promoting clinical research and cough specialty training was acknowledged. Variability in healthcare resources and clinical needs between geographical regions was noted. Conclusions: The Delphi exercise provides a platform and guidance for both established cough clinics and those in planning stages.
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BACKGROUND: This study assesses the incidence of gastrointestinal symptoms in the first year after resection of esophageal or gastric cancer and its association with health-related quality of life (HRQoL), functioning, work productivity, and daily activities. PATIENTS AND METHODS: Patients diagnosed with esophageal or gastric cancer between 2015 and 2021, who underwent a resection, and completed ≥ 2 questionnaires from the time intervals prior to resection and 0-3, 3-6, 6-9, and 9-12 months after resection were included. Multivariable generalized linear mixed models were used to assess changes in gastrointestinal symptoms over time and the impact of the number of gastrointestinal symptoms on HRQoL, functioning, work productivity, and daily activities for patients who underwent an esophagectomy or gastrectomy separately. RESULTS: The study population consisted of 961 (78.8%) and 259 (21.2%) patients who underwent an esophagectomy and gastrectomy, respectively. For both groups, the majority of gastrointestinal symptoms changed significantly over time. Most clinically relevant differences were observed 0-3 after resection compared with prior to resection and included increased diarrhea, appetite loss, and eating restrictions, and specifically after esophagectomy dry mouth, trouble with coughing, and trouble talking. At 9-12 after resection one or more severe gastrointestinal symptoms were reported by 38.9% after esophagectomy and 33.7% after gastrectomy. A higher number of gastrointestinal symptoms was associated with poorer functioning, lower HRQoL, higher impairment in daily activities, and lower work productivity. CONCLUSIONS: This study shows that gastrointestinal symptoms are frequently observed and burdensome after esophagectomy or gastrectomy, highlighting the importance to address these sequelae for high quality survivorship.
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Neoplasias Esofágicas , Neoplasias Gástricas , Humanos , Estudios Longitudinales , Neoplasias Esofágicas/cirugía , Neoplasias Gástricas/cirugía , Incidencia , Calidad de Vida , Gastrectomía , Medición de Resultados Informados por el Paciente , Esofagectomía , Unión Esofagogástrica/cirugíaRESUMEN
Introduction: Survivors of COVID-19 frequently endure chronic disabilities. We hypothesise that diaphragm function has a long recovery time after COVID-19 hospitalisation and may play a role in post-COVID-19 syndrome. The aim of this study was to assess diaphragm function during COVID-19 hospitalisation and during recovery. Methods: We conducted a prospective single-centre cohort study in 49 enrolled patients, of which 28 completed 1-year follow-up. Participants were evaluated for diaphragm function. Diaphragm function was assessed using ultrasound measuring of diaphragm thickening fraction (TF) within 24â h after admission, after 7â days of admission or at discharge, whichever came first, and 3 and 12â months after hospital admission. Results: Estimated mean TF increased from 0.56 (95% CI 0.46-0.66) on admission to 0.78 (95% CI 0.65-0.89) at discharge or 7â days after admission, to 1.05 (95% CI 0.83-1.26) 3â months after admission and to 1.54 (95% CI 1.31-1.76) 12â months after admission. The improvements from admission to discharge, 3â months and 12â months were all significant (linear mixed modelling; p=0.020, p<0.001 and p<0.001, respectively), and the improvement from discharge to 3-month follow-up was borderline significant (p<0.1). Conclusion: Diaphragm function was impaired during hospitalisation for COVID-19. During recovery in hospital and up to 1-year follow-up, diaphragm TF improved, suggesting a long recovery time of the diaphragm. Diaphragm ultrasound may be a valuable modality in the screening and follow-up of (post-)COVID-19 patients for diaphragm dysfunction.
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BACKGROUND: P2X3 receptor antagonists seem to have a promising potential for treating patients with refractory chronic cough. In this double-blind, randomized, placebo-controlled study, we investigated the efficacy, safety, and tolerability of the novel selective P2X3 receptor antagonist filapixant (BAY1902607) in patients with refractory chronic cough. METHODS: Following a crossover design, 23 patients with refractory chronic cough (age: 60.4 ± 9.1 years) received ascending doses of filapixant in one period (20, 80, 150, and 250 mg, twice daily, 4-days-on/3-days-off) and placebo in the other. The primary efficacy endpoint was the 24-h cough frequency on Day 4 of each dosing step. Further, subjective cough severity and health-related quality of life were assessed. RESULTS: Filapixant at doses ≥ 80 mg significantly reduced cough frequency and severity and improved cough health-related quality of life. Reductions in 24-h cough frequency over placebo ranged from 17% (80 mg dose) to 37% (250 mg dose), reductions over baseline from 23% (80 mg) to 41% (250 mg) (placebo: 6%). Reductions in cough severity ratings on a 100-mm visual analog scale ranged from 8 mm (80 mg) to 21 mm (250 mg). No serious or severe adverse events or adverse events leading to discontinuation of treatment were reported. Taste-related adverse events occurred in 4%, 13%, 43%, and 57% of patients treated with filapixant 20, 80, 150, and 250 mg, respectively, and in 12% treated with placebo. CONCLUSIONS: Filapixant proved to be efficacious, safe, and-apart from the occurrence of taste disturbances, especially at higher dosages-well tolerated during the short therapeutic intervention. Clinical trial registration EudraCT, eudract.ema.europa.eu, 2018-000129-29; ClinicalTrials.gov, NCT03535168.
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Tos , Antagonistas del Receptor Purinérgico P2X , Humanos , Persona de Mediana Edad , Anciano , Tos/inducido químicamente , Calidad de Vida , Enfermedad Crónica , Método Doble CiegoRESUMEN
BACKGROUND: Maintenance and reliever therapy (MART) with inhaled corticosteroid (ICS)/formoterol effectively reduces exacerbations in asthma. We aimed to investigate its efficacy compared with fixed-dose fluticasone/salmeterol in chronic obstructive pulmonary disease (COPD). METHODS: Patients with COPD and ≥1 exacerbation in the previous 2 years were randomly assigned to open-label MART (Spiromax budesonide/formoterol 160/4.5 µg 2 inhalations twice daily+1 prn) or fixed-dose therapy (Diskus fluticasone propionate/salmeterol combination (FSC) 500/50 µg 1 inhalation twice daily+salbutamol 100 µg prn) for 1 year. The primary outcome was rate of moderate/severe exacerbations, defined by treatment with oral prednisolone and/or antibiotics. RESULTS: In total, 195 patients were randomised (MART Bud/Form n=103; fixed-dose FSC n=92). No significant difference was seen between MART and FSC therapy in exacerbation rates (1.32 vs 1.32 /year, respectively, rate ratio 1.05 (95% CI 0.79 to 1.39); p=0.741). No differences in lung function parameters or health status were observed. Total ICS dose was significantly lower with MART than FSC therapy (budesonide-equivalent 928 µg/day vs 1747 µg/day, respectively, p<0.05). Similar proportions of patients reported adverse events (MART Bud/Form: 73% vs fixed-dose FSC: 68%, p=0.408) and pneumonias (MART: 5% vs FSC: 1%, p=0.216). CONCLUSIONS: This first study of MART in COPD found that budesonide/formoterol MART might be similarly effective to fluticasone/salmeterol fixed-dose therapy in moderate to severe patients with COPD, at a lower daily ICS dosage. Further evidence is needed about long-term safety.
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Broncodilatadores , Enfermedad Pulmonar Obstructiva Crónica , Humanos , Broncodilatadores/uso terapéutico , Etanolaminas/efectos adversos , Combinación de Medicamentos , Androstadienos/efectos adversos , Resultado del Tratamiento , Combinación Fluticasona-Salmeterol/uso terapéutico , Budesonida/efectos adversos , Fumarato de Formoterol/uso terapéutico , Enfermedad Pulmonar Obstructiva Crónica/tratamiento farmacológico , Combinación Budesonida y Fumarato de Formoterol/uso terapéutico , Corticoesteroides/uso terapéuticoRESUMEN
Anastomotic leakage is a feared complication after esophagectomy and associated with increased post-operative morbidity and mrotality. The aim of this study was to evaluate the management of leakage after robot-assisted minimally invasive esophagectomy (RAMIE) with intrathoracic anastomosis. From a single center prospectively maintained database, all patients with anastomotic leakages defined by the Esophageal Complications Consensus Group between 2016 and 2021 were included. Contained leakage was defined as presence of air or fluid at level of the anastomosis without the involvement of the mediastinum or thorax. Non-contained leakage was defined as mediastinitis and/or mediastinal/pleural fluid collections. The primary outcome was 90-day mortality and the secondary outcome was successful recovery. In this study, 40 patients with anastomotic leakage were included. The 90-day mortality rate was 3% (n = 1). Leakage was considered contained in 29 patients (73%) and non-contained in 11 patients (27%). In the contained group, the majority of the patients were treated non-surgically (n = 27, 93%) and management was successful in 22 patients (76%). In the non-contained group, all patients required a reoperation with thoracic drainage and management was successful in seven patients (64%). Management failed in 11 patients (28%) of whom 7 developed an esophagobronchial fistula, 3 had a disconnection of the anastomosis and 1 died of a septic bleeding. In conclusion, this study demonstrates that the management anastomotic leakage in patients who underwent RAMIE with an intrathoracic anastomosis was successful in 73% of the patients with a 90-day mortality rate of 3%. A differentiated approach for the management of intrathoracic anastomotic leakage is proposed.
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Neoplasias Esofágicas , Robótica , Humanos , Fuga Anastomótica/etiología , Fuga Anastomótica/cirugía , Esofagectomía/efectos adversos , Anastomosis Quirúrgica/efectos adversos , Estudios RetrospectivosRESUMEN
Introduction: Chronic cough affects â¼10% of the population and adversely impacts quality of life. This retrospective observational cohort study aimed to identify the demographics, clinical characteristics and quality of life of the chronic cough population in a Dutch chronic cough clinic, at baseline and following treatment at 6â months. Patients were categorised based on the underlying phenotype and response to treatment. Methods: Retrospective data on 2397 patients who were diagnosed according to standard guidelines of the American College of Chest Physicians were analysed. Quality of life was captured via the Leicester Cough Questionnaire, the Cough Numeric Rating Scale and the Hospital Anxiety and Depression Scale. Results: Mean patient age was 59â years; 62.5% of the patients were female; and 69.1% had at least one underlying phenotype associated with chronic cough. Of the latter, 52.1% had bronchial hyperresponsiveness/airflow limitation, 33.3% had airway reflux and 20.1% had upper airway cough syndrome. 46% of patients with a phenotype, and 51% without, experienced no improvement in their quality of life or still had significant cough remaining after 6â months. Of patients with available quality-of-life data, 37.5% were categorised as having refractory chronic cough, and 9.5% were categorised as unexplained chronic cough. Discussion: This study highlights the poor quality-of-life outcomes in patients with chronic cough, despite interventions to treat underlying conditions, and indicates a need to manage chronic cough irrespective of phenotype.
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Cough is a physiological defense mechanism. However, excessive cough is known to have a great impact on quality of life. Cough is considered to be chronic when it lasts longer than 8 weeks. In the Netherlands, the prevalence is 10.9%. The concept as a whole is called 'cough hypersensitivity' in which there is a hypersensitivity of the cough reflex to aspecific stimuli. Specific treatment of the phenotype is important. If no specific phenotype is found it is called 'unexplained chronic cough' (UCC) and if symptoms persist despite treatment it is called 'chronic refractory cough' (CRC). Neuromodulating drugs are the main treatment in CRC. However, a suitable condition often cannot be achieved because of severe side effect and great interindividual variability in pharmacokinetics. New drugs, P2X3-antagonists, are being developed. These drugs mediate in a late phase of the cough reflex and are thereby considered to have fewer side effects.
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Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Hipersensibilidad , Enfermedad Crónica , Tos/etiología , Humanos , Calidad de VidaRESUMEN
Importance: The optimal staging for gastric cancer remains a matter of debate. Objective: To evaluate the value of 18F-fludeoxyglucose-positron emission tomography with computed tomography (FDG-PET/CT) and staging laparoscopy (SL) in addition to initial staging by means of gastroscopy and CT in patients with locally advanced gastric cancer. Design, Setting, and Participants: This multicenter prospective, observational cohort study included 394 patients with locally advanced, clinically curable gastric adenocarcinoma (≥cT3 and/or N+, M0 category based on CT) between August 1, 2017, and February 1, 2020. Exposures: All patients underwent an FDG-PET/CT and/or SL in addition to initial staging. Main Outcomes and Measures: The primary outcome was the number of patients in whom the intent of treatment changed based on the results of these 2 investigations. Secondary outcomes included diagnostic performance, number of incidental findings on FDG-PET/CT, morbidity and mortality after SL, and diagnostic delay. Results: Of the 394 patients included, 256 (65%) were men and mean (SD) age was 67.6 (10.7) years. A total of 382 patients underwent FDG-PET/CT and 357 underwent SL. Treatment intent changed from curative to palliative in 65 patients (16%) based on the additional FDG-PET/CT and SL findings. FDG-PET/CT detected distant metastases in 12 patients (3%), and SL detected peritoneal or locally nonresectable disease in 73 patients (19%), with an overlap of 7 patients (2%). FDG-PET/CT had a sensitivity of 33% (95% CI, 17%-53%) and specificity of 97% (95% CI, 94%-99%) in detecting distant metastases. Secondary findings on FDG/PET were found in 83 of 382 patients (22%), which led to additional examinations in 65 of 394 patients (16%). Staging laparoscopy resulted in a complication requiring reintervention in 3 patients (0.8%) without postoperative mortality. The mean (SD) diagnostic delay was 19 (14) days. Conclusions and Relevance: This study's findings suggest an apparently limited additional value of FDG-PET/CT; however, SL added considerably to the staging process of locally advanced gastric cancer by detection of peritoneal and nonresectable disease. Therefore, it may be useful to include SL in guidelines for staging advanced gastric cancer, but not FDG-PET/CT.
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Laparoscopía , Tomografía Computarizada por Tomografía de Emisión de Positrones , Neoplasias Gástricas/diagnóstico por imagen , Neoplasias Gástricas/patología , Anciano , Femenino , Fluorodesoxiglucosa F18 , Humanos , Masculino , Estadificación de Neoplasias , Países Bajos , Estudios Prospectivos , RadiofármacosRESUMEN
BACKGROUND: Refractory dyspnea or breathlessness is a common symptom in patients with advanced chronic obstructive pulmonary disease (COPD), with a high negative impact on quality of life (QoL). Low dosed opioids have been investigated for refractory dyspnea in COPD and other life-limiting conditions, and some positive effects were demonstrated. However, upon first assessment of the literature, the quality of evidence in COPD seemed low or inconclusive, and focused mainly on morphine which may have more side effects than other opioids such as fentanyl. For the current publication we performed a systematic literature search. We searched for placebo-controlled randomized clinical trials investigating opioids for refractory dyspnea caused by COPD. We included trials reporting on dyspnea, health status and/or QoL. Three of fifteen trials demonstrated a significant positive effect of opioids on dyspnea. Only one of four trials reporting on QoL or health status, demonstrated a significant positive effect. Two-thirds of included trials investigated morphine. We found no placebo-controlled RCT on transdermal fentanyl. Subsequently, we hypothesized that both fentanyl and morphine provide a greater reduction of dyspnea than placebo, and that fentanyl has less side effects than morphine. METHODS: We describe the design of a robust, multi-center, double blind, double-dummy, cross-over, randomized, placebo-controlled clinical trial with three study arms investigating transdermal fentanyl 12 mcg/h and morphine sustained-release 10 mg b.i.d. The primary endpoint is change in daily mean dyspnea sensation measured on a numeric rating scale. Secondary endpoints are change in daily worst dyspnea, QoL, anxiety, sleep quality, hypercapnia, side effects, patient preference, and continued opioid use. Sixty patients with severe stable COPD and refractory dyspnea (FEV1 < 50%, mMRC ≥ 3, on optimal standard therapy) will be included. DISCUSSION: Evidence for opioids for refractory dyspnea in COPD is not as robust as usually appreciated. We designed a study comparing both the more commonly used opioid morphine, and transdermal fentanyl to placebo. The cross-over design will help to get a better impression of patient preferences. We believe our study design to investigate both sustained-release morphine and transdermal fentanyl for refractory dyspnea will provide valuable information for better treatment of refractory dyspnea in COPD. Trial registration NCT03834363 (ClinicalTrials.gov), registred at 7 Feb 2019, https://clinicaltrials.gov/ct2/show/NCT03834363 .
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Analgésicos Opioides/administración & dosificación , Disnea/tratamiento farmacológico , Estado de Salud , Enfermedad Pulmonar Obstructiva Crónica/tratamiento farmacológico , Relación Dosis-Respuesta a Droga , Método Doble Ciego , Disnea/etiología , Fentanilo/administración & dosificación , Humanos , Morfina/administración & dosificación , Estudios Multicéntricos como Asunto , Enfermedad Pulmonar Obstructiva Crónica/complicaciones , Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como Asunto , Proyectos de InvestigaciónRESUMEN
OBJECTIVE: Chemotherapy in the last month of life for patients with metastatic lung cancer is often considered as aggressive end-of-life care. Targeted therapy with Tyrosine Kinase Inhibitors (TKIs) is a relatively new treatment of which not much is known yet about use in the last month of life. We examined what percentage of patients received chemotherapy or TKIs in the last month of life in the Netherlands. METHODS: Patient files were drawn from 10 hospitals across the Netherlands. Patients had to meet the following eligibility criteria: metastatic lung cancer; died between June 1, 2013 and July 31, 2015. RESULTS: From the included 1,322 patients, 39% received no treatment for metastatic lung cancer, 52% received chemotherapy and 9% received TKIs. A total of 232 patients (18%) received treatment in the last month of life (11% chemotherapy, 7% TKIs). From the patients who received chemotherapy, 145 (21%) received this in the last month of life and 79 (11%) started this treatment in the last month of life. TKIs were given and started more often in the last month of life: from the patients who received TKIs, 87 (72%) received this treatment in the last month of life and 15 (12%) started this treatment in the last month of life. CONCLUSION: A substantial percentage of patient received and even started chemotherapy or TKIs in the last month of life. For chemotherapy, this might be seen as aggressive care. TKIs are said to have less side effects, do not lead to many hospital visits and due to the rapid response, are considered good palliation. However, it is not known, yet possible that, when patients still receiving treatment until shortly before death, this might influence preparing for death in a negative way.
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Antineoplásicos/uso terapéutico , Carcinoma de Pulmón de Células no Pequeñas/tratamiento farmacológico , Neoplasias Pulmonares/tratamiento farmacológico , Inhibidores de Proteínas Quinasas/uso terapéutico , Carcinoma Pulmonar de Células Pequeñas/tratamiento farmacológico , Cuidado Terminal , Factores de Edad , Anciano , Anciano de 80 o más Años , Carcinoma de Pulmón de Células no Pequeñas/genética , Carcinoma de Pulmón de Células no Pequeñas/secundario , Comorbilidad , Femenino , Humanos , Neoplasias Pulmonares/patología , Masculino , Persona de Mediana Edad , Países Bajos , Oncólogos/estadística & datos numéricos , Cuidados Paliativos , Estudios Retrospectivos , Carcinoma Pulmonar de Células Pequeñas/secundarioRESUMEN
CONTEXT: Metastatic lung cancer is an incurable disease that results in a high burden of symptoms, a poor quality of life, and an expected prognosis of less than one year after diagnosis. Treatment shortly before death may result in potential burdensome and inappropriate hospital admissions and hospital deaths. Dying at home is, at a population level, considered a quality for good end-of-life care. OBJECTIVES: We examined what percentage of patients with metastatic lung cancer died inside the hospital and if hospital death, or other characteristics of the patient, oncologist or health care, were associated with treatment in the last month of life. METHODS: This retrospective cohort study evaluated the medical records of 1322 patients with metastatic lung cancer who received care at one of 10 hospitals across The Netherlands and died between 1/6/2013 and 31/7/2015. Demographic and clinical characteristics were obtained from the medical records. RESULTS: In total, 18% of the patients died during a hospital admission. This percentage was higher for patients who received chemotherapy (42%) or targeted therapy with tyrosine kinase inhibitors (25%) in the last month of life. Patients younger than 60 years of age, patients who received chemotherapy in the last month of life, and patients in whom tyrosine kinase inhibitors were started in the last month of life were more likely to die inside the hospital. CONCLUSION: In The Netherlands, fewer than one in five patients with metastatic lung cancer died in the hospital and in-hospital death was associated with the relatively late use of chemotherapy or targeted therapy. Careful selection of patients for disease-modifying therapy might enhance the opportunity for patients to die at their preferred place.
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Antineoplásicos/uso terapéutico , Neoplasias Pulmonares/mortalidad , Calidad de Vida , Cuidado Terminal , Anciano , Anciano de 80 o más Años , Femenino , Mortalidad Hospitalaria , Humanos , Neoplasias Pulmonares/tratamiento farmacológico , Masculino , Persona de Mediana Edad , Países Bajos , Pronóstico , Estudios RetrospectivosRESUMEN
BACKGROUND: Oesophagectomy is a major complex operation associated with significant morbidity and mortality. Epidural analgesia has long been the gold standard postoperative analgesia but is associated with side-effects like hypotension, epidural haematoma and infection. In an attempt to lower morbidity and enhance recovery postoperatively, we have adopted the use of paravertebral catheter analgesia (PVCA) for patients undergoing totally minimal invasive oesophagectomy (TMIO). METHODS: Our objective was to review the current literature about the use of both PVCA and epidural analgesia. In addition, we evaluated the effect of PVCA in a large group of patients undergoing TMIO for cancer. We reviewed the records of 100 consecutive patients who had a TMIO with PVCA, spinal morphine, and PCA. Prospective independent scoring of postoperative pain, length of stay, high-dependency unit (HDU) stay, PVCA failure, the use of patient-controlled analgesia (PCA), and the use of vasoconstrictor medication postoperatively was analysed. RESULTS: One hundred consecutive patients received PVCA with PCA after the TMIO. Catheter related failures occurred in 4 cases. The median pain score over each of the 5 days were 0. The average pain score was highest in the first 24 hours and decreased over the next 4 days postoperatively. The use of PCA was highest in the first 2 days and reduced daily over the subsequent 3 days. Seven patients required rescue analgesia in the form of intercostal nerve (ICN) block. Spinal morphine was successful in 94% of cases. Vasoconstrictors were required in 19% on day 1 and 3% on day 2, postoperatively. CONCLUSIONS: Intraoperative placement of PVCA results in good postoperative pain control after a TMIO. This technique is simple, safe, reproducible and with very low failure rates. Therefore, it should be used instead of epidural catheter analgesia.
RESUMEN
OBJECTIVES: Older patients with chronic obstructive pulmonary disease (COPD), hospitalized for an acute exacerbation, often do not receive recommended post-acute pulmonary rehabilitation. This underuse might be related to the impaired clinical and functional status of these patients, who are more likely to present with frailty, comorbidities, and disability. Having developed and implemented a geriatric rehabilitation program for these patients (GR_COPD), the primary aim of this study was to investigate the effectiveness of this program. DESIGN AND INTERVENTION: A prospective cohort study with a 3-month follow-up period. Patients who declined the GR_COPD program were considered as controls. SETTING AND PARTICIPANTS: The study was conducted at the pulmonary department of 2 hospitals. Patients were eligible when hospitalized as a result of an acute exacerbation of COPD and indicated for the GR_COPD program based on standardized criteria. METHODS: Primary outcome was defined as change in disease-specific health status measured with the clinical COPD questionnaire (CCQ), secondary outcome as the exacerbation rate ratio during follow-up. To balance potential confounders between the intervention and control group, propensity score-based weighted linear regression analyses were performed. RESULTS: Of the 158 included patients [78 (49.4%) male, mean age 70.8 (±8.1) years, mean forced expiratory volume in 1 second: 35.5 (±12.8) as % of predicted], 78 received the GR_COPD program. The results of the CCQ showed a significant and clinically relevant treatment effect of -0.56 points [95% confidence interval (CI) -0.89, -0.23; P = .001). Patients in the control group had 2.77 times more exacerbations compared with the intervention group (95% CI 2.13, 3.58; P < .001). CONCLUSIONS/IMPLICATIONS: This study shows a clinically relevant effect of the GR_COPD program on disease-specific health status and exacerbation rate. Implementation of the program for older patients with severe COPD hospitalized for an acute exacerbation is recommended.