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1.
Semin Radiat Oncol ; 34(2): 164-171, 2024 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-38508781

RESUMEN

Surgical resection is the cornerstone of curative treatment for retroperitoneal sarcomas (RPS), aiming for complete excision, yet the complexity of RPS with its proximity to vital structures continues to lead to high local recurrence rates after surgery alone. Thus, the role of radiotherapy (RT) continues to be refined to improve local control, which remains an important goal to prevent RPS recurrence. The recently completed global randomized trial to evaluate the role of surgery with and without preoperative RT - STRASS1, did not demonstrate a significant overall benefit for neoadjuvant RT based on the pre-specified definition of abdominal recurrence-free survival, however, sensitivity analysis using a standard definition of local recurrence and analysis of outcomes by compliance to the RT protocol suggests histology-specific benefit in well- and some de-differentiated liposarcomas. Ultimately, multidisciplinary collaboration and personalized approaches that consider histological sarcoma types and patient-specific factors are imperative for optimizing the therapeutic strategy in the management of RPS.


Asunto(s)
Neoplasias Retroperitoneales , Sarcoma , Humanos , Sarcoma/radioterapia , Sarcoma/cirugía , Sarcoma/patología , Neoplasias Retroperitoneales/radioterapia , Neoplasias Retroperitoneales/cirugía , Neoplasias Retroperitoneales/patología , Terapia Combinada , Radioterapia Adyuvante , Terapia Neoadyuvante , Recurrencia Local de Neoplasia/prevención & control , Recurrencia Local de Neoplasia/radioterapia
2.
J Clin Oncol ; 41(28): 4535-4547, 2023 10 01.
Artículo en Inglés | MEDLINE | ID: mdl-37467395

RESUMEN

PURPOSE: The optimal neoadjuvant treatment for resectable carcinoma of the thoracic esophagus (TE) or gastroesophageal junction (GEJ) remains a matter of debate. We performed an individual participant data (IPD) network meta-analysis (NMA) of randomized controlled trials (RCTs) to study the effect of chemotherapy or chemoradiotherapy, with a focus on tumor location and histology subgroups. PATIENTS AND METHODS: All, published or unpublished, RCTs closed to accrual before December 31, 2015 and having compared at least two of the following strategies were eligible: upfront surgery (S), chemotherapy followed by surgery (CS), and chemoradiotherapy followed by surgery (CRS). All analyses were conducted on IPD obtained from investigators. The primary end point was overall survival (OS). The IPD-NMA was analyzed by a one-step mixed-effect Cox model adjusted for age, sex, tumor location, and histology. The NMA was registered in PROSPERO (CRD42018107158). RESULTS: IPD were obtained for 26 of 35 RCTs (4,985 of 5,807 patients) corresponding to 12 comparisons for CS-S, 12 for CRS-S, and four for CRS-CS. CS and CRS led to increased OS when compared with S with hazard ratio (HR) = 0.86 (0.75 to 0.99), P = .03 and HR = 0.77 (0.68 to 0.87), P < .001 respectively. The NMA comparison of CRS versus CS for OS gave a HR of 0.90 (0.74 to 1.09), P = .27 (consistency P = .26, heterogeneity P = .0038). For CS versus S, a larger effect on OS was observed for GEJ versus TE tumors (P = .036). For the CRS versus S and CRS versus CS, a larger effect on OS was observed for women (P = .003, .012, respectively). CONCLUSION: Neoadjuvant chemotherapy and chemoradiotherapy were consistently better than S alone across histology, but with some variation in the magnitude of treatment effect by sex for CRS and tumor location for CS. A strong OS difference between CS and CRS was not identified.


Asunto(s)
Carcinoma , Neoplasias Esofágicas , Femenino , Humanos , Carcinoma/tratamiento farmacológico , Quimioradioterapia , Quimioterapia Adyuvante , Neoplasias Esofágicas/patología , Unión Esofagogástrica/patología , Terapia Neoadyuvante , Metaanálisis en Red , Ensayos Clínicos Controlados Aleatorios como Asunto , Masculino
3.
Ann Surg Oncol ; 30(8): 5142-5149, 2023 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-37237094

RESUMEN

OBJECTIVE: In this study, we aimed to describe the clinical features, management, and outcomes of desmoid tumors (DTs) in familial adenomatous polyposis (FAP) patients at a high-volume sarcoma center. METHODS: Consecutive patients with FAP and DTs were identified from our institutional databases (1985-2021). Patient demographics, treatment, and outcomes were described. Categorical data were compared using Fisher's exact test, and Kaplan-Meier curves were used to estimate progression-free survival (PFS). RESULTS: Forty-five patients with 67 DTs were identified: 39 mesenteric or retroperitoneal (58.2%), 17 abdominal wall (25.4%), 4 extremity (6%), 4 breast (6%) and 3 back (4.4%). Severe DT symptoms were present in 12 patients (26.7%). Initial treatments per tumor were observation in 30 (44.8%) DTs, chemotherapy in 15 (22.4%) DTs, surgery in 10 (14.9%) DTs, and other systemic therapies in 10 (14.9%) DTs. The majority of DTs remained stable with observation or a single intervention (77.8%). Median PFS was 23.4 years (95% confidence interval 7.6-39.2). In the 12 severely symptomatic patients, four patients required more than two interventions for DT control. At a median follow-up of 6.0 years (range 0.7-35.8 years), 33 (73.3%) patients were alive with disease, 7 (15.6%) were alive without disease, and 5 (11.1%) died of other causes. No patients died of DT-related complications. CONCLUSIONS: The majority of DTs in FAP patients remained stable with observation or a single intervention. There were no DT-related deaths; however, 12 of 45 patients (26.7%) experienced significant tumor morbidity and required more interventions for disease control. Further studies on quality of life are required.


Asunto(s)
Poliposis Adenomatosa del Colon , Fibromatosis Agresiva , Humanos , Fibromatosis Agresiva/patología , Calidad de Vida , Poliposis Adenomatosa del Colon/complicaciones , Mesenterio/patología
4.
Intern Emerg Med ; 18(2): 559-566, 2023 03.
Artículo en Inglés | MEDLINE | ID: mdl-36746888

RESUMEN

Having a beard is an independent predictor of difficult ventilation by face mask. This study evaluates the efficacy of a novel intra-oral Bag-Valve-Guedel Adaptor (BVGA) in anaesthetized bearded patients. Patients with ASA score 1-2, scheduled for elective surgery, were recruited for this prospective, crossover trial. Beard length was categorized as < 0.5 cm, 0.5-1 cm, 1-5 cm, or > 5 cm. Patients were ventilated by attending anesthesiologists using the BVGA and a facemask (both with a Guedel oral airway). End-tidal CO2 (EtCO2) and expiratory tidal volume (TV) were recorded as was the number of hands required for the procedure. The primary outcome was the difference between BVGA and Facemask. Sixty-one patients were enrolled. Of these, 38 had beards, and 23 were without beards or with beards < 0.5 cm length. In bearded patients, ventilation with the BVGA was superior to the face mask by EtCO2 and non-inferior by TV (BVGA-vs-Mask, mean [95% CI]: EtCO2 [mmHg], 33.0 [31.6, 34.3]-vs-27.2 [25.5, 28.8], p < 0.001; TV [ml∙kg-1 IBW], 8.1 [7.4, 8.9]-vs-6.9 [6.0, 7.7], p = 0.11). The BVGA was found to be superior to the face mask by EtCO2 across all beard lengths (p ≤ 0.001), but by TV only for the longest beard group (p = 0.009). After securing the BVGA, ventilation was possible without hands in 74% of the cases - clearly impossible with the facemask (p ≤ 0.001). The BVGA is more effective and more convenient than the facemask in anaesthetized bearded patients. A follow-up study is underway to test whether replacing the face mask with the BVGA will improve effectiveness and ease of pre-intubation field ventilation by less-experienced, first responders.


Asunto(s)
Manejo de la Vía Aérea , Máscaras Laríngeas , Ventilación , Humanos , Estudios Cruzados , Estudios de Seguimiento , Estudios Prospectivos , Respiración Artificial , Volumen de Ventilación Pulmonar
7.
Placenta ; 110: 29-38, 2021 07.
Artículo en Inglés | MEDLINE | ID: mdl-34116499

RESUMEN

INTRODUCTION: Brief hypercapnic challenge causes acute placental hypoperfusion with fetal brain sparing on BOLD-MRI. We hypothesize that this non-invasive imaging strategy can distinguish between normal pregnancy and chronic placental hypoperfusion (using the maternal hypoxia model). METHODS: Eighteen pregnant female ICR mice were randomized to three groups: normoxia, late-onset hypoxia (12%O2;E13.5-17.5) and early-onset hypoxia (12%O2;E10.5-17.5). On E17.5, animals were imaged in a 4.7-T Bruker-Biospec MRI scanner. Fast coronal True-FISP was performed to identify organs of interest (placenta and fetal heart, liver and brain). BOLD-MRI was performed at baseline and during a 4-min hypercapnic challenge (5%CO2). %-change in placental and fetal signal was analyzed from T2*-weighted gradient echo MR images. Following MRI, fetuses and placentas were harvested, weighed and immuno-stained. RESULTS: In normoxic mice, hypercapnia caused reduction in BOLD-MRI signal in placenta (-44% ± 7%; p < 0.0001), fetal liver (-32% ± 7%; p < 0.0001) and fetal heart (-54% ± 12%; p < 0.002), with relative fetal brain sparing (-12% ± 5%; p < 0.0001). These changes were markedly attenuated in both hypoxia groups. Baseline fetal brain/placenta SI ratio was highest in normoxic mice (1.14 ± 0.017) and reduced with increasing duration of hypoxia (late-onset hypoxia: 1.00 ± 0.026; early-onset hypoxia: 0.91 ± 0.016; p = 0.02). Both hypoxic groups exhibited fetal growth restriction with prominent placental glycogen-containing cells, particularly in early-onset hypoxia. There was increased fetal neuro- and intestinal-apoptosis in early-onset hypoxia only. CONCLUSIONS: BOLD-MRI with brief hypercapnic challenge distinguished between normoxia and both hypoxia groups, while fetal neuroapoptosis was only observed after early-onset hypoxia. This suggests that BOLD-MRI with hypercapnic challenge can identify chronic fetal asphyxia before the onset of irreversible brain injury.


Asunto(s)
Feto/irrigación sanguínea , Hipercapnia/etiología , Hipoxia/complicaciones , Placenta/irrigación sanguínea , Enfermedad Aguda , Animales , Enfermedad Crónica , Modelos Animales de Enfermedad , Embrión de Mamíferos , Femenino , Retardo del Crecimiento Fetal/diagnóstico por imagen , Retardo del Crecimiento Fetal/patología , Retardo del Crecimiento Fetal/fisiopatología , Hipoxia Fetal/diagnóstico por imagen , Hipoxia Fetal/etiología , Hipoxia Fetal/patología , Hipoxia Fetal/fisiopatología , Feto/diagnóstico por imagen , Hemodinámica , Hipercapnia/diagnóstico por imagen , Hipercapnia/patología , Hipercapnia/fisiopatología , Hipoxia/diagnóstico por imagen , Hipoxia/patología , Hipoxia/fisiopatología , Imagen por Resonancia Magnética/métodos , Ratones , Ratones Endogámicos ICR , Placenta/diagnóstico por imagen , Insuficiencia Placentaria/diagnóstico por imagen , Insuficiencia Placentaria/patología , Insuficiencia Placentaria/fisiopatología , Embarazo , Complicaciones del Embarazo/diagnóstico por imagen , Complicaciones del Embarazo/patología , Complicaciones del Embarazo/fisiopatología , Diagnóstico Prenatal/métodos
8.
J Clin Oncol ; 39(18): 1995-2004, 2021 06 20.
Artículo en Inglés | MEDLINE | ID: mdl-33891478

RESUMEN

PURPOSE: Preoperative chemoradiotherapy according to the chemoradiotherapy for esophageal cancer followed by surgery study (CROSS) has become a standard of care for patients with locally advanced resectable esophageal or junctional cancer. We aimed to assess long-term outcome of this regimen. METHODS: From 2004 through 2008, we randomly assigned 366 patients to either five weekly cycles of carboplatin and paclitaxel with concurrent radiotherapy (41.4 Gy in 23 fractions, 5 days per week) followed by surgery, or surgery alone. Follow-up data were collected through 2018. Cox regression analyses were performed to compare overall survival, cause-specific survival, and risks of locoregional and distant relapse. The effect of neoadjuvant chemoradiotherapy beyond 5 years of follow-up was tested with time-dependent Cox regression and landmark analyses. RESULTS: The median follow-up was 147 months (interquartile range, 134-157). Patients receiving neoadjuvant chemoradiotherapy had better overall survival (hazard ratio [HR], 0.70; 95% CI, 0.55 to 0.89). The effect of neoadjuvant chemoradiotherapy on overall survival was not time-dependent (P value for interaction, P = .73), and landmark analyses suggested a stable effect on overall survival up to 10 years of follow-up. The absolute 10-year overall survival benefit was 13% (38% v 25%). Neoadjuvant chemoradiotherapy reduced risk of death from esophageal cancer (HR, 0.60; 95% CI, 0.46 to 0.80). Death from other causes was similar between study arms (HR, 1.17; 95% CI, 0.68 to 1.99). Although a clear effect on isolated locoregional (HR, 0.40; 95% CI, 0.21 to 0.72) and synchronous locoregional plus distant relapse (HR, 0.43; 95% CI, 0.26 to 0.72) persisted, isolated distant relapse was comparable (HR, 0.76; 95% CI, 0.52 to 1.13). CONCLUSION: The overall survival benefit of patients with locally advanced resectable esophageal or junctional cancer who receive preoperative chemoradiotherapy according to CROSS persists for at least 10 years.


Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Neoplasias Esofágicas/terapia , Anciano , Carboplatino/administración & dosificación , Neoplasias Esofágicas/mortalidad , Esofagectomía , Femenino , Humanos , Estimación de Kaplan-Meier , Escisión del Ganglio Linfático , Masculino , Persona de Mediana Edad , Terapia Neoadyuvante , Países Bajos/epidemiología , Paclitaxel/administración & dosificación , Resultado del Tratamiento
9.
Clin Case Rep ; 9(2): 1027-1028, 2021 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-33598291

RESUMEN

Hairy cell leukemia can cause massive splenomegaly which may lead to urinary retention and constipation. Patients usually require a splenectomy for relief of symptoms.

10.
Cureus ; 12(8): e9826, 2020 Aug 18.
Artículo en Inglés | MEDLINE | ID: mdl-32953335

RESUMEN

Lung cancer metastases to soft tissues are rarely reported in the literature. In this report, we discuss a case of a 59-year-old female who presented with worsening shortness of breath for over five months. A CT scan of the chest revealed right upper lobe mass and ipsilateral mediastinal adenopathy. An endo-bronchial ultrasound (EBUS)-guided biopsy of the involved lymph nodes revealed cellular features consistent with lung adenocarcinoma. MRI of the brain was negative for metastases; however, a positron emission testing (PET) scan showed fluorodeoxyglucose (FDG)-avid nodules in the soft tissues of the bilateral buttocks. Tissue biopsy of the buttock lesions confirmed metastases of lung origin. To the best of our knowledge, this is the first case report of metastatic lung adenocarcinoma with occult involvement of the gluteal muscles as the sole site of distant metastasis.

11.
Cureus ; 12(7): e8993, 2020 Jul 03.
Artículo en Inglés | MEDLINE | ID: mdl-32775075

RESUMEN

Hepatosplenic T-cell lymphoma is a rare but highly aggressive form of T-cell malignancy. As cases are not routinely seen in practice, the malignancy can be confused with other hematologic conditions that have a similar presentation. Here in, we present the challenges faced in diagnosing a 27-year-old-male who initially presented with asymptomatic pancytopenia and then developed massive splenomegaly over the next three months. After an elaborate workup, including a bone marrow biopsy and extensive serological testing, which all turned out to be negative, he eventually underwent a splenectomy with biopsy results confirming hepatosplenic T-cell lymphoma.

12.
Harefuah ; 159(6): 440-447, 2020 Jun.
Artículo en Hebreo | MEDLINE | ID: mdl-32583648

RESUMEN

INTRODUCTION: Intrathecal morphine administration at the time of neuraxial anesthesia performance is the gold standard for post-cesarean delivery (CD) analgesia. When intrathecal morphine administration is inappropriate or contraindicated, the use of systemic analgesic options increase side effects and risks to both the parturient and the breastfeeding neonate. Moreover, systemic analgesia is often inadequate. The increased clinical use of ultrasound has made way for regional analgesia techniques, mostly in the form of local anesthesia injected between muscular planes. The transversus abdominis plane (TAP) block is the most well-known and the most commonly used for Cesarean delivery. It has been shown to be effective in the absence of intrathecal morphine administration. It has however, not been shown to be beneficial when intrathecal morphine has been administered. Other, newer techniques are being increasingly used and investigated. Some may prove to be superior to the TAP block. These techniques include: ilioinguinal/ilio-hypogastric nerve blocks (II-IH), the quadratus lumborum (QL) blocks and the erector spinae plane (ESP) block. In this review, we will discuss and assess these techniques regarding analgesia following CD.


Asunto(s)
Analgesia/métodos , Cesárea , Bloqueo Nervioso/métodos , Músculos Abdominales , Pared Abdominal , Analgésicos Opioides , Anestésicos Locales , Femenino , Humanos , Recién Nacido , Dolor Postoperatorio , Embarazo
13.
Placenta ; 90: 52-57, 2020 01 15.
Artículo en Inglés | MEDLINE | ID: mdl-32056552

RESUMEN

INTRODUCTION: We previously reported blood oxygen level dependent MRI (BOLD-MRI) for monitoring placental and fetal hemodynamic changes in mice following maternal hypercapnia. Here we use BOLD-MRI to compare the placental and fetal hemodynamic effects of different maternal vasopressors in mice. METHODS: Pregnant ICR mice (n = 16; E17.5) anesthetized with pentobarbital (80 mg/kg i.p.) were placed supine in a 4.7-T Bruker Biospec MRI. Following baseline images, equipotential doses of ephedrine (10 mg/kg) or phenylephrine (10mcg/kg) were administered intravenously. Changes in placental and fetal signal were analyzed from T2*-weighted gradient echo MR images (TR/TE = 147/10 ms). Different regions of interest (placenta, fetal heart, fetal liver and fetal brain) were identified. Percentage change of BOLD-MRI signal intensity (SI) were presented as time curves. RESULTS: Ephedrine and phenylephrine elicited markedly different effects. Phenylephrine caused an approximate 50% reduction in placental, fetal heart and fetal liver BOLD-MRI-SI, but fetal brain BOLD-MRI-SI was unchanged (statistically different from placenta and other fetal organs; p < 0.001), and the fetal brain/liver BOLD-MRI-SI ratio was markedly increased versus baseline (p < 0.001). Following ephedrine, placental BOLD-MRI-SI increased 30% and fetal heart BOLD-MRI-SI was reduced 26%; other fetal organs were unchanged. Blood gases were unchanged. DISCUSSION: Phenylephrine induced BOLD-MRI-SI changes suggestive of placental and fetal hypoperfusion with brain sparing. Ephedrine induced BOLD-MRI-SI changes suggestive of increased cardiac output; we speculate that reduced fetal heart BOLD-MRI-SI may be due to increased fetal myocardial oxygen extraction or metabolic acidosis. The result demonstrates the potential of BOLD-MRI as a non-invasive hemodynamic tool for assessing pharmacodynamics effects in the placental and fetus.


Asunto(s)
Encéfalo/efectos de los fármacos , Efedrina/farmacología , Feto/efectos de los fármacos , Fenilefrina/farmacología , Placenta/efectos de los fármacos , Vasoconstrictores/farmacología , Animales , Encéfalo/diagnóstico por imagen , Femenino , Feto/diagnóstico por imagen , Hemodinámica/efectos de los fármacos , Imagen por Resonancia Magnética , Ratones , Placenta/diagnóstico por imagen , Embarazo
14.
IEEE Trans Vis Comput Graph ; 26(1): 853-862, 2020 01.
Artículo en Inglés | MEDLINE | ID: mdl-31425111

RESUMEN

Students who eat breakfast more frequently tend to have a higher grade point average. From this data, many people might confidently state that a before-school breakfast program would lead to higher grades. This is a reasoning error, because correlation does not necessarily indicate causation - X and Y can be correlated without one directly causing the other. While this error is pervasive, its prevalence might be amplified or mitigated by the way that the data is presented to a viewer. Across three crowdsourced experiments, we examined whether how simple data relations are presented would mitigate this reasoning error. The first experiment tested examples similar to the breakfast-GPA relation, varying in the plausibility of the causal link. We asked participants to rate their level of agreement that the relation was correlated, which they rated appropriately as high. However, participants also expressed high agreement with a causal interpretation of the data. Levels of support for the causal interpretation were not equally strong across visualization types: causality ratings were highest for text descriptions and bar graphs, but weaker for scatter plots. But is this effect driven by bar graphs aggregating data into two groups or by the visual encoding type? We isolated data aggregation versus visual encoding type and examined their individual effect on perceived causality. Overall, different visualization designs afford different cognitive reasoning affordances across the same data. High levels of data aggregation by graphs tend to be associated with higher perceived causality in data. Participants perceived line and dot visual encodings as more causal than bar encodings. Our results demonstrate how some visualization designs trigger stronger causal links while choosing others can help mitigate unwarranted perceptions of causality.

15.
ACG Case Rep J ; 6(7): e00138, 2019 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-31620535

RESUMEN

Upper gastrointestinal bleeding (UGIB) is a life-threatening complication and a commonly encountered diagnosis requiring hospitalization. It is defined as bleeding proximal to the ligament of Treitz with the most common cause being peptic ulcer disease. There are multiple causes of UGIB and each of them presents its own unique diagnostic and management challenges. We present a rare case of UGIB due to endometrial adenocarcinoma metastatic to the third part of the duodenum. Most common sites of metastasis from endometrial adenocarcinoma are pelvic and paraaortic lymph nodes, and it is very rare for endometrial cancer to metastasize in gastrointestinal tract and then present as UGIB.

16.
Cancers (Basel) ; 11(2)2019 Feb 01.
Artículo en Inglés | MEDLINE | ID: mdl-30717316

RESUMEN

Inter-individual variability in paclitaxel pharmacokinetics may play a role in the response to chemotherapy. Therefore, we studied the association between paclitaxel clearance and treatment response in patients with esophageal cancer. All patients who received paclitaxel (plus carboplatin) treatment for esophageal cancer between 2007 and 2013 were included. The treatment was given as neoadjuvant chemoradiotherapy (nCRT), induction chemotherapy (iCT), or palliative chemotherapy (pCT). The treatment response was assessed by the tumor regression grade (TRG) or by the RECIST1.1 criteria, respectively. The unbound paclitaxel clearance (CL) was estimated with NONMEM. The log-transformed clearance was related to response with ANOVA and independent sample t-tests. A total of 166 patients were included, of whom 113 received nCRT, 23 iCT and 30 pCT. In patients receiving nCRT, paclitaxel clearance was not associated with tumor regression grade (p-value = 0.25), nor with pathologically complete response (geometric mean 561.6 L/h) and residual disease (geometric mean 566.1 L/h, p-value = 0.90). In patients who underwent iCT or pCT, also no association between paclitaxel clearance and RECIST outcome was identified (iCT: p-value = 0.08 and pCT: p-value = 0.81, respectively). In conclusion, systemic paclitaxel exposure was not associated with response to common paclitaxel-based treatment regimens for esophageal cancer. Future studies should focus on tumor exposure in relation to systemic exposure and treatment outcome.

17.
Lancet Oncol ; 19(7): 965-974, 2018 07.
Artículo en Inglés | MEDLINE | ID: mdl-29861116

RESUMEN

BACKGROUND: After neoadjuvant chemoradiotherapy for oesophageal cancer, roughly half of the patients with squamous cell carcinoma and a quarter of those with adenocarcinoma have a pathological complete response of the primary tumour before surgery. Thus, the necessity of standard oesophagectomy after neoadjuvant chemoradiotherapy should be reconsidered for patients who respond sufficiently to neoadjuvant treatment. In this study, we aimed to establish the accuracy of detection of residual disease after neoadjuvant chemoradiotherapy with different diagnostic approaches, and the optimal combination of diagnostic techniques for clinical response evaluations. METHODS: The preSANO trial was a prospective, multicentre, diagnostic cohort study at six centres in the Netherlands. Eligible patients were aged 18 years or older, had histologically proven, resectable, squamous cell carcinoma or adenocarcinoma of the oesophagus or oesophagogastric junction, and were eligible for potential curative therapy with neoadjuvant chemoradiotherapy (five weekly cycles of carboplatin [area under the curve 2 mg/mL per min] plus paclitaxel [50 mg/m2 of body-surface area] combined with 41·4 Gy radiotherapy in 23 fractions) followed by oesophagectomy. 4-6 weeks after completion of neoadjuvant chemoradiotherapy, patients had oesophagogastroduodenoscopy with biopsies and endoscopic ultrasonography with measurement of maximum tumour thickness. Patients with histologically proven locoregional residual disease or no-pass during endoscopy and without distant metastases underwent immediate surgical resection. In the remaining patients a second clinical response evaluation was done (PET-CT, oesophagogastroduodenoscopy with biopsies, endoscopic ultrasonography with measurement of maximum tumour thickness, and fine-needle aspiration of suspicious lymph nodes), followed by surgery 12-14 weeks after completion of neoadjuvant chemoradiotherapy. The primary endpoint was the correlation between clinical response during clinical response evaluations and the final pathological response in resection specimens, as shown by the proportion of tumour regression grade (TRG) 3 or 4 (>10% residual carcinoma in the resection specimen) residual tumours that was missed during clinical response evaluations. This study was registered with the Netherlands Trial Register (NTR4834), and has been completed. FINDINGS: Between July 22, 2013, and Dec 28, 2016, 219 patients were included, 207 of whom were included in the analyses. Eight of 26 TRG3 or TRG4 tumours (31% [95% CI 17-50]) were missed by endoscopy with regular biopsies and fine-needle aspiration. Four of 41 TRG3 or TRG4 tumours (10% [95% CI 4-23]) were missed with bite-on-bite biopsies and fine-needle aspiration. Endoscopic ultrasonography with maximum tumour thickness measurement missed TRG3 or TRG4 residual tumours in 11 of 39 patients (28% [95% CI 17-44]). PET-CT missed six of 41 TRG3 or TRG4 tumours (15% [95% CI 7-28]). PET-CT detected interval distant histologically proven metastases in 18 (9%) of 190 patients (one squamous cell carcinoma, 17 adenocarcinomas). INTERPRETATION: After neoadjuvant chemoradiotherapy for oesophageal cancer, clinical response evaluation with endoscopic ultrasonography, bite-on-bite biopsies, and fine-needle aspiration of suspicious lymph nodes was adequate for detection of locoregional residual disease, with PET-CT for detection of interval metastases. Active surveillance with this combination of diagnostic modalities is now being assessed in a phase 3 randomised controlled trial (SANO trial; Netherlands Trial Register NTR6803). FUNDING: Dutch Cancer Society.


Asunto(s)
Quimioradioterapia/métodos , Neoplasias Esofágicas/mortalidad , Neoplasias Esofágicas/terapia , Neoplasia Residual/mortalidad , Neoplasia Residual/terapia , Área Bajo la Curva , Biopsia con Aguja Fina , Estudios de Cohortes , Supervivencia sin Enfermedad , Endosonografía/métodos , Neoplasias Esofágicas/patología , Femenino , Humanos , Masculino , Persona de Mediana Edad , Terapia Neoadyuvante , Invasividad Neoplásica/patología , Estadificación de Neoplasias , Neoplasia Residual/patología , Tomografía Computarizada por Tomografía de Emisión de Positrones/métodos , Pronóstico , Estudios Prospectivos , Medición de Riesgo , Tasa de Supervivencia
18.
Trials ; 19(1): 263, 2018 May 02.
Artículo en Inglés | MEDLINE | ID: mdl-29720238

RESUMEN

BACKGROUND: Acute appendicitis is one of the most common indications for emergency surgery. In patients with a complex appendicitis, prolonged antibiotic prophylaxis is recommended after appendectomy. There is no consensus regarding the optimum duration of antibiotics. Guidelines propose 3 to 7 days of treatment, but shorter courses may be as effective in the prevention of infectious complications. At the same time, the global issue of increasing antimicrobial resistance urges for optimization of antibiotic strategies. The aim of this study is to determine whether a short course (48 h) of postoperative antibiotics is non-inferior to current standard practice of 5 days. METHODS: Patients of 8 years and older undergoing appendectomy for acute complex appendicitis - defined as a gangrenous and/or perforated appendicitis or appendicitis in presence of an abscess - are eligible for inclusion. Immunocompromised or pregnant patients are excluded, as well as patients with a contraindication to the study antibiotics. In total, 1066 patients will be randomly allocated in a 1:1 ratio to the experimental treatment arm (48 h of postoperative intravenously administered (IV) antibiotics) or the control arm (5 days of postoperative IV antibiotics). After discharge from the hospital, patients participate in a productivity-cost-questionnaire at 4 weeks and a standardized telephone follow-up at 90 days after appendectomy. The primary outcome is a composite endpoint of infectious complications, including intra-abdominal abscess (IAA) and surgical site infection (SSI), and mortality within 90 days after appendectomy. Secondary outcomes include IAA, SSI, restart of antibiotics, length of hospital stay (LOS), reoperation, percutaneous drainage, readmission rate, and cost-effectiveness. The non-inferiority margin for the difference in the primary endpoint rate is set at 7.5% (one-sided test at ɑ 0.025). Both per-protocol and intention-to-treat analyses will be performed. DISCUSSION: This trial will provide evidence on whether 48 h of postoperative antibiotics is non-inferior to a standard course of 5 days of antibiotics. If non-inferiority is established, longer intravenous administration following appendectomy for complex appendicitis can be abandoned, and guidelines need to be adjusted accordingly. TRIAL REGISTRATION: Dutch Trial Register, NTR6128 . Registered on 20 December 2016.


Asunto(s)
Absceso Abdominal/prevención & control , Antibacterianos/administración & dosificación , Apendicectomía , Apendicitis/cirugía , Infección de la Herida Quirúrgica/prevención & control , Absceso Abdominal/economía , Absceso Abdominal/microbiología , Absceso Abdominal/mortalidad , Administración Intravenosa , Antibacterianos/efectos adversos , Antibacterianos/economía , Apendicectomía/efectos adversos , Apendicectomía/economía , Apendicectomía/mortalidad , Apendicitis/economía , Apendicitis/microbiología , Apendicitis/mortalidad , Ensayos Clínicos Fase IV como Asunto , Análisis Costo-Beneficio , Esquema de Medicación , Costos de los Medicamentos , Estudios de Equivalencia como Asunto , Femenino , Costos de Hospital , Humanos , Tiempo de Internación , Masculino , Estudios Multicéntricos como Asunto , Países Bajos , Estudios Prospectivos , Factores de Riesgo , Infección de la Herida Quirúrgica/economía , Infección de la Herida Quirúrgica/microbiología , Infección de la Herida Quirúrgica/mortalidad , Factores de Tiempo , Resultado del Tratamiento
20.
Anesth Analg ; 127(1): 224-227, 2018 07.
Artículo en Inglés | MEDLINE | ID: mdl-29239954

RESUMEN

Continuous femoral nerve block (cFNB) is thought to increase the risk of falls after total knee arthroplasty (TKA). Previous studies have failed to consider the timing of cFNB removal in relation to inpatient falls. We investigated all inpatient falls after TKA over a 3-year period using our institutional safety report database. Ninety-five falls were reported from a total of 3745 patients. The frequency of falls after TKA persisted at a similar rate despite removal of cFNB and likely regression of femoral nerve block. Other modifiable risk factors may play a more prominent role in falls risk after TKA.


Asunto(s)
Accidentes por Caídas , Artroplastia de Reemplazo de Rodilla/efectos adversos , Nervio Femoral , Pacientes Internos , Articulación de la Rodilla/cirugía , Bloqueo Nervioso/efectos adversos , Anciano , Anciano de 80 o más Años , Bases de Datos Factuales , Femenino , Humanos , Articulación de la Rodilla/fisiopatología , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento
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