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BACKGROUND: Real-world (RW) evidence on nivolumab in pretreated patients with non-small cell lung cancer (NSCLC) by matching data from administrative health flows (AHFs) and clinical records (CRs) may close the gap between pivotal trials and clinical practice. METHODS: This multicenter RW study aims at investigating median time to treatment discontinuation (mTTD), overall survival (mOS) of nivolumab in pretreated patients with NSCLC both from AHF and CR; clinical-pathological features predictive of early treatment discontinuation (etd), budget impact (BI), and cost-effectiveness analysis were investigated; mOS in patients receiving nivolumab and docetaxel was assessed. RESULTS: Overall, 237 patients with NSCLC treated with nivolumab were identified from AHFs; mTTD and mOS were 4.2 and 9.8 months, respectively; 141 (59%) received at least 6 treatment cycles, 96 (41%) received < 6 (etd). Median overall survival in patients with and without etd were 3.3 and 19.6 months, respectively (P < .0001). Higher number, longer duration, and higher cost of hospitalizations were observed in etd cases. Clinical records were available for 162 patients treated with nivolumab (cohort 1) and 83 with docetaxel (cohort 2). Median time to treatment discontinuation was 4.8 and 2.6 months, respectively (P < .0001); risk of death was significantly higher in cohort 2 or cohort 1 with etd compared with cohort 1 without etd (P < .0001). Predictors of etd were body mass index <25, Eastern Cooperative Oncology Group performance status >1, neutrophile-to-lymphocyte ratio >2.91, and concomitant treatment with antibiotics and glucocorticoids. The incremental cost-effectiveness ratio of nivolumab was 3323.64 euros ($3757.37) in all patients and 2805.75 euros ($3171.47) for patients without etd. Finally, the BI gap (real-theoretical) was 857 188 euros ($969 050.18). CONCLUSION: We defined predictors and prognostic-economic impact of nivolumab in etd patients.
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Antineoplásicos Inmunológicos , Carcinoma de Pulmón de Células no Pequeñas , Neoplasias Pulmonares , Antineoplásicos Inmunológicos/farmacología , Antineoplásicos Inmunológicos/uso terapéutico , Carcinoma de Pulmón de Células no Pequeñas/patología , Docetaxel/uso terapéutico , Humanos , Neoplasias Pulmonares/patología , Nivolumab/efectos adversos , Estudios RetrospectivosRESUMEN
BACKGROUND: Esophageal lipomatous tumors, also reported as fibrovascular polyp, fibrolipoma, angiolipoma, and liposarcoma, account for less than 1% of all benign mesenchymal submucosal tumors of the esophagus. Clinical presentation and therapy may differ based on location, size, and morphology. A comprehensive and updated systematic review of the literature is lacking. METHODS: A systematic review of the literature was performed according to PRISMA guidelines. Pubmed, Embase, Cochrane, and Medline databases were consulted using MESH keywords. Non-English written articles and abstracts were excluded. Sex, age, symptoms at presentation, diagnosis, tumor location and size, surgical approach and technique of excision, pathology, and morphology were extracted and recorded in an electronic database. RESULTS: Sixty-seven studies for a total of 239 patients with esophageal lipoma or liposarcoma were included in the qualitative analysis. Among 176 patients with benign lipoma, the median age was 55. The main symptoms were dysphagia (64.2%), transoral polyp regurgitation (32.4%), and globus sensation (22.7%). The majority of lipomas (85.7%) were intraluminal polyps, with a stalk originating from the upper esophagus. Overall, 165 patients underwent excision of the mass through open surgery (65.5%), endoscopy (27.9%), or laparoscopy/thoracoscopy (3.6%). Only 5 (3%) of patients required esophagectomy. Of the 11 untreated patients with an intraluminal polyp, 7 died from asphyxia. Overall, liposarcoma was diagnosed in 63 patients, and 12 (19%) underwent esophagectomy. CONCLUSION: Esophageal lipomatous tumors are rare but potentially lethal when are intraluminal and originate from the cervical esophagus. Modern radiological imaging has improved diagnostic accuracy. Minimally invasive transoral and laparoscopic/thoracoscopic techniques represent the therapeutic approach of choice.
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Neoplasias Esofágicas , Lipoma , Neoplasias Esofágicas/cirugía , Esofagectomía , Humanos , Lipoma/diagnóstico por imagen , Lipoma/cirugía , Liposarcoma/diagnóstico por imagen , Liposarcoma/cirugíaRESUMEN
INTRODUCTION: Gefitinib, erlotinib, and afatinib represent the approved first-line options for epidermal growth factor receptor (EGFR)-mutant non-small cell lung cancer (NSCLC). Because pivotal trials frequently lack external validity, real-world data may help to depict the diagnostic-therapeutic pathway and treatment outcome in clinical practice. METHODS: MOST is a multicenter observational study promoted by the Veneto Oncology Network, aiming at monitoring the diagnostic-therapeutic pathway of patients with nonsquamous EGFR-mutant NSCLC. We reported treatment outcome in terms of median time to treatment failure (mTTF) and assessed the impact of each agent on the expense of the regional health system, comparing it with a prediction based on the pivotal trials. RESULTS: An EGFR mutation test was performed in 447 enrolled patients, of whom 124 had EGFR mutation and who received gefitinib (n = 69, 55%), erlotinib (n = 33, 27%), or afatinib (n = 22, 18%) as first-line treatment. Because erlotinib was administered within a clinical trial to 15 patients, final analysis was limited to 109 patients. mTTF was 15.3 months, regardless of the type of tyrosine kinase inhibitor (TKI) used. In the MOST study, the budget impact analysis showed a total expense of 3,238,602.17, whereas the cost estimation according to median progression-free survival from pivotal phase III trials was 1,813,557.88. CONCLUSION: Good regional adherence and compliance to the diagnostic-therapeutic pathway defined for patients with nonsquamous NSCLC was shown. mTTF did not significantly differ among the three targeted TKIs. Our budget impact analysis suggests the potential application of real-world data in the process of drug price negotiation. IMPLICATIONS FOR PRACTICE: The MOST study is a real-world data collection reporting a multicenter adherence and compliance to diagnostic-therapeutic pathways defined for patients with epidermal growth factor receptor-mutant non-small cell lung cancer. This represents an essential element of evidence-based medicine, providing information on patients and situations that may be challenging to assess using only data from randomized controlled trials, e.g., turn-around time of diagnostic tests, treatment compliance and persistence, guideline adherence, challenging-to-treat populations, drug safety, comparative effectiveness, and cost effectiveness. This study may be of interest to various stakeholders (patients, clinicians, and payers), providing a meaningful picture of the value of a given therapy in routine clinical practice.
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Carcinoma de Pulmón de Células no Pequeñas/tratamiento farmacológico , Vías Clínicas/estadística & datos numéricos , Neoplasias Pulmonares/tratamiento farmacológico , Inhibidores de Proteínas Quinasas/uso terapéutico , Adulto , Afatinib/economía , Afatinib/uso terapéutico , Anciano , Anciano de 80 o más Años , Carcinoma de Pulmón de Células no Pequeñas/diagnóstico , Carcinoma de Pulmón de Células no Pequeñas/economía , Carcinoma de Pulmón de Células no Pequeñas/genética , Análisis Costo-Beneficio , Vías Clínicas/normas , Análisis Mutacional de ADN/normas , Análisis Mutacional de ADN/estadística & datos numéricos , Progresión de la Enfermedad , Supervivencia sin Enfermedad , Receptores ErbB/antagonistas & inhibidores , Receptores ErbB/genética , Clorhidrato de Erlotinib/economía , Clorhidrato de Erlotinib/uso terapéutico , Femenino , Estudios de Seguimiento , Gefitinib/economía , Gefitinib/uso terapéutico , Adhesión a Directriz/normas , Humanos , Neoplasias Pulmonares/diagnóstico , Neoplasias Pulmonares/economía , Neoplasias Pulmonares/genética , Masculino , Cumplimiento de la Medicación/estadística & datos numéricos , Persona de Mediana Edad , Mutación , Guías de Práctica Clínica como Asunto , Supervivencia sin Progresión , Estudios Prospectivos , Inhibidores de Proteínas Quinasas/economía , Factores de Tiempo , Insuficiencia del TratamientoRESUMEN
PRIMARY OBJECTIVE: To report consistent recovery of consciousness to a state of severe disability in a young patient after 7 years in vegetative state due to severe acquired brain injury, with reflections on protraction of intensive care and expert follow-up for the purpose of intercepting possible, albeit infrequent, cases of late recovery of consciousness. RESEARCH DESIGN: Single case study Methods: This study describes the 9-year history of a healthy 15-year-old who suffered cerebellar haemorrhage due to rupture of an arteriovenous malformation, followed by a brief period of coma then protracted vegetative state; late stabilization of general condition with resolution of neurosurgical complications. Clinical monitoring employed scales for structured assessment of severe disability and disorders of consciousness. RESULTS: The transition from vegetative state to full consciousness occurred over a period of ~ 3 months, 7 years after onset. In the subsequent 2 years the patient has shown slow but progressive overall improvement in a framework of severe residual motor and cognitive disability. CONCLUSIONS: Cases of recovery of consciousness after periods of vegetative state exceeding 1 year are rare, but remind one that a negative prognosis decided too early may be a self-fulfilling forecast.
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Malformaciones Arteriovenosas Intracraneales/complicaciones , Estado Vegetativo Persistente/etiología , Recuperación de la Función , Adolescente , Evaluación de la Discapacidad , Femenino , Humanos , Pronóstico , Adulto JovenRESUMEN
BACKGROUND: Long-term outcomes and predictors of success after transoral stapling for Zenker diverticulum are still unclear. METHODS: Between 2001 and 2010, 91 patients with Zenker diverticulum underwent transoral stapling under general anesthesia. Since 2008, the technique was modified by applying traction sutures to ease engagement of the common septum inside the stapler jaws. Perioperative variables, distribution of symptoms, and outcome of surgery were analyzed. Long-term results were compared between patients undergoing standard versus modified technique of transoral stapling. RESULTS: The transoral approach was successfully completed in 79 (86.8 %) patients with a median age of 74 years. Overall morbidity was 5 %, and there was no mortality. The median length of hospital stay was 2 days. Six patients were lost to follow-up. After a median follow-up of 53 (range, 12-114) months, an improvement of dysphagia and regurgitation scores (p < 0.001) and a reduction in the number of pneumonia episodes per year (p < 0.001) was recorded. The long-term success rate of the procedure was 80.1 %. At a median time of 12 months, 14 patients complained of recurrent symptoms, 7 of whom needed an open (n = 4) or transoral (n = 3) reoperation. Use of traction sutures resulted in a greater long-term success compared with the standard procedure (p = 0.04). CONCLUSIONS: Transoral stapling is a safe and effective technique. A repeat procedure is feasible in case of recurrent diverticulum. The use of traction sutures applied at the apex of the common septum before stapling might increase the long-term success of the technique.
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Grapado Quirúrgico/métodos , Divertículo de Zenker/cirugía , Anciano , Femenino , Estudios de Seguimiento , Humanos , Tiempo de Internación , Masculino , Satisfacción del Paciente/estadística & datos numéricos , Recurrencia , Resultado del TratamientoRESUMEN
Background: Breast cancer may present with distinct cutaneous manifestations that may be paraneoplastic or secondary to direct skin infiltration, distant skin metastases, or dermal lymphatic tumor embolization (inflammatory breast carcinoma). Case report: A 51-year-old Asian woman visited the emergency care department during the outbreak of COVID-19 in Northern Italy. About 6 months before, she had noted the onset of right breast swelling accompanied by skin redness and itching. She never consulted a physician, and, over time, the local skin condition progressed to a large scaly plaque covering the entire breast surface including the nipple. At presentation, abduction of the right upper limb was impaired due to severe shoulder pain. CT scan showed the presence of bilateral breast masses with necrotic and colliquative features, and multiple skeletal, nodal, pulmonary, and brain images suggestive of metastases. An ultrasound-guided core biopsy of the contralateral breast showed grade 2 non-special type infiltrating carcinoma. The patient was referred to the breast oncology unit and is currently being treated with aromatase inhibitors and chemotherapy. Conclusion: The COVID-19 pandemic has disrupted the entire spectrum of oncological care including breast cancer. Hopefully, telemedicine will contribute to increase patients' confidence and will provide earlier diagnosis and treatment while minimizing the risk of contagion.
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PURPOSE: Colovesical fistula (CVF) is a rare complication of sigmoid diverticulitis causing significant morbidity and quality of life impairment. Aim of this study was to analyze contemporary literature data to appraise the current standard of care and changes of treatment algorithms over time. MATERIALS AND METHODS: A systematic review of the literature on surgical management of CVF was conducted through PUBMED, EMBASE, and COCHRANE databases, according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses statement guidelines. RESULTS: Fourteen papers published between 2014 and 2020 and including 1061 patients were analyzed. One-stage colonic resection with primary anastomosis, with or without loop ileostomy, was the most common surgical procedure. A laparoscopic or robotic approach was attempted in 39.5% of patients, and conversion rate to open surgery was 7.8%. Clavien-Dindo grade ≥3 complication rate, 30-day mortality, and recurrence rate were 7.4%, 1.5%, and 0.5%, respectively. CONCLUSIONS: Minimally invasive sigmoidectomy with primary anastomosis is safe and should be the first-choice approach for CVF. Bladder repair is not necessary after a negative intraoperative leak test. A standardized perioperative care can improve clinical outcomes and reduce the length of hospital stay and the duration of Foley catheterization.
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Diverticulitis del Colon , Fístula Intestinal , Laparoscopía , Colon Sigmoide/cirugía , Conversión a Cirugía Abierta , Diverticulitis del Colon/cirugía , Humanos , Fístula Intestinal/complicaciones , Fístula Intestinal/cirugía , Laparoscopía/métodos , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/cirugía , Calidad de Vida , Resultado del TratamientoRESUMEN
Background: Crural repair is an essential technical component in laparoscopic hiatal hernia surgery, but there is no consensus regarding the optimal method to prevent postoperative hernia recurrence. Mesh augmentation, especially with permanent materials, is associated with dysphagia and complications. The rotational falciform ligament flap (FLF) has been reported to be effective in reinforcing standard suture closure of the hiatus. Materials and Methods: Patients with primary or secondary hiatal hernia in whom FLF was used to buttress the hiatus repair were included. The FLF was dissected from the anterior abdominal wall, detached from the umbilical area, and transposed below the left lateral liver segment to buttress the cruroplasty. Indocyanine green fluorescence was used to assess vascularization of the flap before and after mobilization. Results: Eighteen consecutive patients underwent laparoscopic FLF cruroplasty reinforcement between October 2019 and January 2021. Indications were primary hiatal hernia (n = 9), recurrent hiatal hernia (n = 4), postsleeve gastrectomy hernia (n = 1), prophylactic hiatal repair during esophagectomy and gastric conduit reconstruction (n = 2), and postesophagectomy hernia (n = 2). All flaps were well vascularized and covered the entire hiatal area. There was no morbidity. At a median follow-up of 8 months (range 3-15), the symptomatic and quality of life scores significantly improved compared with baseline (P < .001), and no anatomic hernia recurrences were detected. Conclusions: FLF is safe for crural buttress and is a viable alternative to mesh in laparoscopic hiatal hernia surgery.
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Hernia Hiatal/cirugía , Herniorrafia/métodos , Laparoscopía/métodos , Ligamentos/trasplante , Colgajos Quirúrgicos/cirugía , Adulto , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Prevención Secundaria/métodos , Resultado del TratamientoRESUMEN
The novel coronavirus disease 2019 (COVID-19) pandemic has been an overwhelming challenge for worldwide health systems. Since the beginning of year 2020, COVID-19 has represented a potential harm for cancer patients and has often hindered oncology care. The Collegio Italiano dei Primari Oncologi Medici (CIPOMO) is an Italian association of head physicians in oncology departments, which promotes working and research activities in oncology on a national basis. During the second wave of COVID-19 pandemic, the CIPOMO promoted a national survey aiming to evaluate the impact of COVID-19 on oncologists' clinical activity and what changes have been made compared with the Italian situation during the first wave of the pandemic. Overall, 138 heads of medical oncology departments participated in this survey: 75 (54%) from the North, 24 (17%) from the Centre and 39 (28%) from the South of Italy and islands. This survey provides an overview of Italian oncologists facing the second wave of COVID-19 pandemic. The lesson learned during the first wave of COVID-19 pandemic has led to a better organisation of clinical activities, and regular testing among healthcare practitioners, with better chances to grant patients' protection. However, the lack of standardised informatic platforms results in serious challenges in replacing frontal visits, often making a concrete reduction of patients' hospital accesses unfeasible. Oncologists need to keep preserving the continuum of care of patients. Standardisation of safety measures, together with the implementation of informatic platforms, can significantly improve oncology pathways during this second wave of COVID-19 pandemic.
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COVID-19/prevención & control , Continuidad de la Atención al Paciente , Neoplasias/terapia , Oncólogos , Pautas de la Práctica en Medicina , Telemedicina , COVID-19/diagnóstico , COVID-19/terapia , Prueba de Ácido Nucleico para COVID-19/estadística & datos numéricos , Humanos , Italia , Tamizaje Masivo , Servicio de Oncología en Hospital/organización & administración , Admisión y Programación de Personal , SARS-CoV-2 , Encuestas y CuestionariosRESUMEN
INTRODUCTION: Coronavirus disease 2019 (COVID-19) pandemic started in Italy with clusters identified in Northern Italy. The Veneto Oncology Network (Rete Oncologica Veneta) licenced dedicated guidelines to ensure proper care minimising the risk of infection in patients with cancer. Rete Oncologica Veneta covID19 (ROVID) is a regional registry aimed at describing epidemiology and clinical course of Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in patients with cancer. MATERIALS AND METHODS: Patients with cancer diagnosis and documented SARS-CoV-2 infection are eligible. Data on cancer diagnosis, comorbidities, anticancer treatments, as well as details on SARS-CoV-2 infection (hospitalisation, treatments, fate of the infection), have been recorded. Logistic regression analysis was applied to calculate the association between clinical/laboratory variables and death from any cause. RESULTS: One hundred seventy patients have been enrolled. The median age at time of the SARS-CoV infection was 70 years (25-92). The most common cancer type was breast cancer (n = 40). The majority of the patients had stage IV disease. Half of the patients had two or more comorbidities. The majority of the patients (78%) presented with COVID-19 symptoms. More than 77% of the patients were hospitalized and 6% were admitted to intensive care units. Overall, 104 patients have documented resolution of the infection. Fifty-seven patients (33%) have died. In 29 cases (17%), the cause of death was directly correlated to SARS-CoV-2 infection. Factors significantly correlated with the risk of death were the following: Eastern Cooperative Oncology Group performance status (PS), age, presence of two or more comorbidities, presence of dyspnoea, COVID-19 phenotype ≥ 3, hospitalisation, intensive care unit admission, neutrophil/lymphocyte ratio and thrombocytopenia. CONCLUSIONS: The mortality rate reported in this confirms the frailty of this population. These data reinforce the need to protect patients with cancer from SARS-CoV-2 infection.
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COVID-19/diagnóstico , COVID-19/epidemiología , Neoplasias/diagnóstico , Neoplasias/epidemiología , Adulto , Anciano , Anciano de 80 o más Años , COVID-19/complicaciones , COVID-19/patología , Redes Comunitarias , Progresión de la Enfermedad , Femenino , Mortalidad Hospitalaria , Hospitalización/estadística & datos numéricos , Humanos , Unidades de Cuidados Intensivos/estadística & datos numéricos , Italia/epidemiología , Masculino , Persona de Mediana Edad , Neoplasias/complicaciones , Neoplasias/patología , Pandemias , Pronóstico , Sistema de Registros , SARS-CoV-2/fisiología , Índice de Severidad de la EnfermedadRESUMEN
Background: Although gastric carcinoma is the fifth most commonly diagnosed cancer, optimal treatment of perforated cancer remains debated. Materials and Methods: The study was conducted according to the guidelines from the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statement. An electronic systematic search was conducted using MEDLINE databases (PubMed, EMBASE, and Web of Science) by matching the terms "perforated gastric cancer," "gastric cancer perforated," "perforation AND gastric cancer," and "perforated gastric tumor." Results: Fifteen studies published between 1995 and 2018 and including 964 patients matched the inclusion criteria for this systematic review. There were 4 publications from Japan, 3 from Turkey, and 1 from China, Germany, Hong Kong, Italy, Nepal, Serbia, South Korea, and Taiwan, respectively. The sample size of the individual studies ranged from 8 to 514 patients. Perforated gastric carcinoma was rare and more prevalent in elderly males, preoperative diagnosis was uncommon, and the distal stomach was most frequently involved. Mortality was 11.4% and 1.9%, respectively, in one-stage versus two-stage gastrectomy (P = .010). Curative treatment by omental patch repair and staged gastrectomy yielded acceptable 5-year survival rates. There were no significant differences in the recurrence rate and pattern between perforated and nonperforated gastric cancer if a curative operation was performed. Use of laparoscopy was mentioned only in one study. Conclusions: Future studies should evaluate the role of laparoscopic surgery and clarify the indications for hyperthermic intraperitoneal chemotherapy and extensive peritoneal lavage protocols to decrease gastric cancer cell shed in the surgical field and increase long-term survival.
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Gastrectomía , Recurrencia Local de Neoplasia/cirugía , Neoplasias Gástricas/cirugía , Humanos , Hipertermia Inducida , Laparoscopía , Recurrencia Local de Neoplasia/mortalidad , Lavado Peritoneal , Peritonitis/cirugía , Prevalencia , Pronóstico , Recurrencia , Neoplasias Gástricas/mortalidad , Tasa de Supervivencia , Resultado del TratamientoRESUMEN
Psoas abscess is a rare and occasionally life-threatening condition. In the past, the major cause of psoas abscess was a descending infection originating from spine tuberculosis (Pott's disease). Subsequently, secondary infection from spondylodiscitis or Crohn's disease has become the prevalent aetiology. Conventional treatment ranges from antibiotic therapy alone to CT-guided and/or surgical drainage. We present the case of a 67-year-old man with a complex history, including pneumonia, sepsis and previous muscle-skeletal trauma. The patient subsequently developed a psoas abscess that was successfully treated with a minimally invasive retroperitoneoscopic approach and antibiotics. Blood cultures and pus yielded Gram-positive Streptococcus sp, and transesophageal echocardiography identified endocarditis as a possible source of sepsis. Postoperative clinical course was complicated by recurrent sepsis that required a change of antibiotic therapy. The patient was eventually discharged to rehabilitation care without further complications. The retroperitoneoscopic approach is safe and effective for the treatment of cryptogenic psoas abscess.
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Antibacterianos/uso terapéutico , Drenaje/métodos , Endoscopía/métodos , Absceso del Psoas/terapia , Espacio Retroperitoneal/cirugía , Anciano , Humanos , Masculino , Absceso del Psoas/microbiología , Infecciones Estreptocócicas/microbiología , Infecciones Estreptocócicas/terapia , Streptococcus intermediusRESUMEN
Background: Malignant rhabdoid tumor is a kidney childhood tumor with aggressive clinical behavior and a wide spectrum of histologic, immunophenotypic, and cytogenetic findings. Extra-renal rhabdoid tumors have been reported in the brain, breast, liver, pancreas, bladder, vulva, prostate, and colon. To date, only nine cases of esophageal rhabdoid tumors have been described, all in patients over 50-year old. We add to the current literature the case of an esophageal, poorly differentiated rhabdoid tumor occurring in a young man. Case Report: A 24-year-old man was referred for progressive dysphagia, retrosternal pain, nausea, and food regurgitation. Esophagogastroduodenoscopy showed an obstructing neoplastic lesion of the distal esophagus associated with Barrett's esophagus. Biopsies revealed undifferentiated esophageal cancer with epithelial morphology and immunohistochemistry positive for CK pan, CK 7 e CK 8-18. Minimally invasive esophagectomy and extended lymphadenectomy was performed. Histopathology showed a poorly differentiated tumor, with morphologic characteristics of rhabdoid tumor, central necrosis and transmural infiltration of the esophageal wall. Definitive immunohistochemistry was positive for vimentin, CD34, synaptophysin, and INI1. Conclusion: Esophageal rhabdoid tumor is extremely rare and highly aggressive, with only few patients alive at 1 year follow-up, according to our review. Immunohistochemistry characterization is critical for diagnosis. Minimally invasive esophagectomy is an appealing and possibly less morbid option compared to open surgery. However, further research is needed to investigate the potential role of targeted immunotherapy.
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The magnetic sphincter augmentation (MSA) device has been proven safe and effective in controlling typical reflux symptoms and esophageal acid exposure for up to 6-year follow-up. Longer term outcomes have not been reported yet. A prospectively maintained database was reviewed to assess long-term safety and efficacy of the laparoscopic MSA procedure at a single referral center. Gastro-Esophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL), use of proton-pump inhibitors (PPI), and esophageal acid exposure were compared to baseline. Favorable outcomes were defined as ≥ 50% improvement of GERD-HRQL total score and PPI discontinuation. Between March 2007 and March 2020, 335 patients met the study inclusion criteria, and 124 of them were followed from 6 to 12 years after surgery (median 9 years, IQR 2). Mean total GERD-HRQL score significantly improved from 19.9 to 4.01 (p < 0.001), and PPI were discontinued by 79% of patients. The mean total percent time with pH < 4 decreased from 9.6% at baseline to 4.1% (p < 0.001), with 89% of patients achieving pH normalization. Independent predictors of a favorable outcome were age at intervention < 40 years (OR 4.17) and GERD-HRQL score > 15 (OR 4.09). We confirm long-term safety and efficacy of MSA in terms of symptom improvement, decreased drug dependency, and reduced esophageal acid exposure.
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Esfínter Esofágico Inferior/cirugía , Esófago/cirugía , Reflujo Gastroesofágico/cirugía , Evaluación de Resultado en la Atención de Salud , Prótesis e Implantes/efectos adversos , Adulto , Esófago/patología , Femenino , Humanos , Laparoscopía/efectos adversos , Laparoscopía/métodos , Imanes , Masculino , Persona de Mediana Edad , Calidad de Vida , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
Esophageal lipoma is a rare neoplasm with heterogeneous and sometimes life-threatening clinical presentation. We report the case of two patients, a 77-year-old man and a 69-year-old woman presenting with heartburn and dysphagia, and with recurrent vomiting and asphyxia, respectively. Upper gastrointestinal endoscopy and computed tomography were highly suggestive of the diagnosis of esophageal lipoma and identified an intramural and an intraluminal pedunculated mass originating, respectively, from the distal and the cervical esophagus. The first patient was treated by laparoscopic transhiatal enucleation and the second by transoral endoscopic resection under general anesthesia. Both had an uneventful postoperative course and were discharged home on postoperative day 2. Minimally invasive excision of esophageal lipoma is feasible and effective. It may be life-saving in patients with pedunculated tumors who suffer from intermittent regurgitation of a bulky polypoid mass in the mouth causing asphyxia.
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BACKGROUND: Psoas abscess is a relatively rare clinical condition that can occur worldwide, is difficult to diagnose, and has a severe clinical course. Conventional treatment ranges from antibiotic therapy alone to computed tomography (CT)-guided and/or open surgical drainage. Retroperitoneoscopic drainage represents a minimally invasive and potentially definitive therapeutic option. MATERIALS AND METHODS: A systematic review of the literature on minimally invasive extraperitoneal access for drainage of psoas abscess was conducted through PUBMED, EMBASE, and COCHRANE databases, according to the PRISMA statement guidelines. We considered only studies in English and with a full text. The quality of all selected articles was assessed for the risk of methodological bias. Additional literature sources were used to put into context the indications and limits of retroperitoneoscopic drainage. RESULTS: Seven papers published between 2004 and 2020, including a total of 56 patients, met the eligibility criteria and were included in the qualitative analysis. Causative agents of psoas abscess included Mycobacterium tuberculosis, Klebsiella pneumoniae, Enterobacter aerogenes, Staphylococcus aureus, and Streptococcus spp. Tuberculous abscess was more common than pyogenic abscess (92.8% vs. 7.2%). Main clinical findings were back pain (76.8%) and fever (53.6%). All patients were preoperatively evaluated by CT or magnetic resonance imaging. Only 4 patients (7.1%) had previously undergone CT-guided percutaneous drainage. Retroperitoneoscopic drainage was combined with antibiotic therapy in all cases. No Clavien-Dindo grade >3 complications occurred, and there was no 30-day postoperative mortality. The recurrence rate was 1.8% at a mean follow-up of 21 months. CONCLUSION: Retroperitoneoscopic surgical drainage is a safe and effective approach for the treatment of psoas abscess.
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Absceso del Psoas , Infecciones Estafilocócicas , Drenaje , Humanos , Imagen por Resonancia Magnética , Absceso del Psoas/cirugía , Tomografía Computarizada por Rayos XRESUMEN
BACKGROUND: Mediastinal leakage (ML) is one of the most feared complications of esophagectomy. A standard strategy for its diagnosis and treatment has been difficult to establish because of the great variability in their incidence and mortality rates reported in the existing series. AIM: To assess the incidence, predictive factors, treatment, and associated mortality rate of mediastinal leakage using the standardized definition of mediastinal leaks recently proposed by the Esophagectomy Complications Consensus Group (ECCG). METHODS: Seven Italian surgical centers (five high-volume, two low-volume) affiliated with the Italian Society for the Study of Esophageal Diseases designed and implemented a retrospective study including all esophagectomies (n = 501) with intrathoracic esophagogastric anastomosis performed from 2014 to 2017. Anastomotic MLs were defined according to the classification recently proposed by the ECCG. RESULTS: Fifty-nine cases of ML were recorded, yielding an overall incidence of 11.8% (95%CI: 9.1%-14.9%). The surgical approach significantly influenced the occurrence of ML: the proportion of leakage was 10.5% and 9% after open and hybrid esophagectomy (HE), respectively, and doubled (20%) after totally minimally invasive esophagectomy (TMIE) (P = 0.016). No other predictive factors were found. The 30- and 90-d overall mortality rates were 1.4% and 3.2%, respectively; the 30- and 90-d leak-related mortality rates were 5.1% and 10.2%, respectively; the 90-d mortality rates for TMIE and HE were 5.9% and 1.8%, respectively. Endoscopy was the first-line treatment in 49% of ML cases, with the need for retreatment in 17.2% of cases. Surgery was needed in 44.1% of ML cases. Endoscopic treatment had the lowest mortality rate (6.9%). Removal of the gastric tube with stoma formation was necessary in 8 (13.6%) cases. CONCLUSION: The incidence of ML after esophagectomy was high mainly in the TMIE group. However, the general and specific (leak-related) mortality rates were low. Early treatment (surgical or endoscopic) of severe leaks is mandatory to limit related mortality.
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Fuga Anastomótica/epidemiología , Neoplasias Esofágicas/cirugía , Esofagectomía/efectos adversos , Mediastino/cirugía , Anastomosis Quirúrgica/métodos , Fuga Anastomótica/terapia , Neoplasias Esofágicas/patología , Esofagectomía/métodos , Esofagoscopía/efectos adversos , Esofagoscopía/métodos , Esófago/patología , Esófago/cirugía , Femenino , Humanos , Incidencia , Italia/epidemiología , Masculino , Estudios Retrospectivos , Tasa de SupervivenciaRESUMEN
Minimally invasive esophagectomy has become the preferred approach for invasive Barrett's adenocarcinoma because it can speed recovery and enhance patient's quality of life. Multiple minimally invasive surgical techniques have been described during the last two decades. Preoperative staging, anatomy and physiological patient's status, comorbidity, and experience of the surgical team should drive the choice of the surgical approach. The trans-thoracic Ivor Lewis esophagectomy, either hybrid or totally minimal invasive, remains the preferred approach in these patients. Lymph node yield and short-term clinical outcomes have proven similar to open surgery, while quality of life appears improved. To establish a minimally invasive esophagectomy program, a steep learning curve and a multidisciplinary approach are required in order to provide optimal staging, personalized therapy, and adequate perioperative care. The role of minimally invasive surgery in the treatment of invasive Barrett's adenocarcinoma will continue to expand in synergy with enhanced recovery after surgery pathways.
RESUMEN
BACKGROUND: In a previous proof of concept study, transhiatal pleural drain has been shown to be safe and effective after hybrid Ivor Lewis esophagectomy. Aim of this study was to compare the short-term outcomes of transhiatal and intercostal pleural drainage. PATIENTS AND METHODS: This is an observational retrospective cohort study. Two methods of pleural drainage were compared in patients undergoing hybrid Ivor Lewis esophagectomy. Patients treated with a transhiatal drain connected to a vacuum bag were compared to a historical cohort of patients treated with the conventional intercostal drain connected to underwater seal and suction. Postoperative morbidity, total and daily drainage output, serum albumin levels, and total dose of paracetamol and ketorolac administered on demand were recorded. RESULTS: Between January 2014 and December 2016, 50 patients with transhiatal drain and 50 with intercostal drains met the criteria for inclusion in the study. Demographic and clinicopathological variables were similar in the two groups. There was no statistically significant difference in the rate of postoperative complications. The total volume of drain output and the serum albumin levels were similar in the two groups. The total dose of ketorolac was significantly reduced in patients with transhiatal drain (P < .001). CONCLUSIONS: Transhiatal pleural drainage connected to a portable vacuum system could safely replace the intercostal drain after hybrid Ivor Lewis esophagectomy. It has the potential to reduce postoperative pain and use of nonsteroidal anti-inflammatory drugs, and to enhance recovery from surgery.