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PURPOSE: The aim of the study was to compare the perioperative outcomes of patients affected by inflammatory bowel disease (IBD) who underwent surgery performed through laparoscopy or using the Medtronic Hugo™ RAS. METHODS: This is a retrospective study from a prospectively maintained database comparing laparoscopic vs. robotic-assisted surgery for IBD from 01/11/2017 to 15/04/2024. All procedures were performed by a single surgeon robotic-naïve with a large experience in laparoscopic surgery for IBD. The robotic procedures were performed using the Medtronic Hugo™ RAS platform. Outcomes were 30-day postoperative complications, operative time, conversion rate, intraoperative complications, length of hospital stay, and readmission rate. RESULTS: Among 121 consecutive patients, 80 underwent laparoscopic (LG) and 41 robotic-assisted surgery (RG). Baseline, preoperative and disease-specific characteristics were comparable except for older age (50 [38-56] vs. 38 [28-54] years; p = 0.05) and higher albumin level (42 [40-44] vs. 40 [38-42] g/L, p = 0.006) in the RG. The intracorporeal anastomosis was more frequent in the RG (80% vs. 6%; p < 0.001) with longer operative time (240 vs. 205 min; p = 0.006), while the conversion rate was not different (5% vs. 10%, p = 0.49). Surgical procedure types were equally distributed between the two groups, and the rate of intra-abdominal septic complication (IASC) was comparable across the different procedures. Postoperative complications were similar, including the rate of IASC (5% vs. 5%, p = 1), postoperative ileus (5% vs. 7.5%, p = 0.71), bleeding (2% vs. 5%, p = 0.66), and Clavien-Dindo > 2 complications (7% vs. 6%; p = 1). CONCLUSION: IBD surgery performed using the Medtronic Hugo™ RAS is safe and feasible, with similar postoperative outcomes when compared to the laparoscopic approach.
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Doenças Inflamatórias Intestinais , Laparoscopia , Complicações Pós-Operatórias , Procedimentos Cirúrgicos Robóticos , Humanos , Procedimentos Cirúrgicos Robóticos/efeitos adversos , Procedimentos Cirúrgicos Robóticos/métodos , Masculino , Feminino , Pessoa de Meia-Idade , Doenças Inflamatórias Intestinais/cirurgia , Adulto , Resultado do Tratamento , Complicações Pós-Operatórias/etiologia , Laparoscopia/efeitos adversos , Duração da Cirurgia , Tempo de Internação , Readmissão do Paciente , Estudos RetrospectivosRESUMO
INTRODUCTION: In June 2023, our institution adopted the Medtronic Hugo RAS system for colorectal procedures. This system's independent robotic arms enable personalized docking configurations. This study presents our refined multi-docking strategy for robotic low anterior resection (LAR) and deep pelvic procedures, designed to maximize the Hugo RAS system's potential in rectal surgery, and evaluates the associated learning curve. METHODS: This retrospective analysis included 31 robotic LAR procedures performed with the Hugo RAS system using our novel multi-docking strategy. Docking times were the primary outcome. The Mann-Kendall test, Spearman's correlation, and cumulative sum (CUSUM) analysis were used to assess the learning curve and efficiency gains associated with the strategy. RESULTS: Docking times showed a significant negative trend (p < 0.01), indicating improved efficiency with experience. CUSUM analysis confirmed a distinct learning curve, with proficiency achieved around the 15th procedure. The median docking time was 6 min, comparable to other robotic platforms after proficiency. CONCLUSION: This study demonstrates the feasibility and effectiveness of a multi-docking strategy in robotic LAR using the Hugo RAS system. Our personalized approach, capitalizing on the system's unique features, resulted in efficient docking times and streamlined surgical workflow. This approach may be particularly beneficial for surgeons transitioning from laparoscopic to robotic surgery, facilitating a smoother adoption of the new technology. Further research is needed to validate the generalizability of these findings across different surgical settings and experience levels.
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Procedimentos Cirúrgicos Robóticos , Centros de Atenção Terciária , Humanos , Feminino , Masculino , Pessoa de Meia-Idade , Pelve/cirurgia , Curva de Aprendizado , Idoso , Adulto , Estudos RetrospectivosAssuntos
Neoplasias Colorretais , Complicações Pós-Operatórias , Humanos , Neoplasias Colorretais/cirurgia , Neoplasias Colorretais/patologia , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/epidemiologia , Estudos Multicêntricos como Assunto , Hospitais com Alto Volume de Atendimentos , Resultado do Tratamento , Hospitais com Baixo Volume de Atendimentos/estatística & dados numéricosRESUMO
BACKGROUND: Wnt/ß-catenin signalling impairment accounts for 85% of colorectal cancers (CRCs), including sporadic and familial adenomatous polyposis (FAP) settings. An altered PI3K/mTOR pathway and gut microbiota also contribute to CRC carcinogenesis. We studied the interplay between the two pathways and the microbiota composition within each step of CRC carcinogenesis. METHODS: Proteins and target genes of both pathways were analysed by RT-qPCR and IHC in tissues from healthy faecal immunochemical test positive (FIT+, n = 17), FAP (n = 17) and CRC (n = 15) subjects. CRC-related mutations were analysed through NGS and Sanger. Oral, faecal and mucosal microbiota was profiled by 16 S rRNA-sequencing. RESULTS: We found simultaneous hyperactivation of Wnt/ß-catenin and PI3K/mTOR pathways in FAP-lesions compared to CRCs. Wnt/ß-catenin molecular markers positively correlated with Clostridium_sensu_stricto_1 and negatively with Bacteroides in FAP faecal microbiota. Alistipes, Lachnospiraceae, and Ruminococcaceae were enriched in FAP stools and adenomas, the latter also showing an overabundance of Lachnoclostridium, which positively correlated with cMYC. In impaired-mTOR-mutated CRC tissues, p-S6R correlated with Fusobacterium and Dialister, the latter also confirmed in the faecal-ecosystem. CONCLUSIONS: Our study reveals an interplay between Wnt/ß-catenin and PI3K/mTOR, whose derangement correlates with specific microbiota signatures in FAP and CRC patients, and identifies new potential biomarkers and targets to improve CRC prevention, early adenoma detection and treatment.
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Carcinogênese , Neoplasias Colorretais , Fosfatidilinositol 3-Quinases , Serina-Treonina Quinases TOR , Via de Sinalização Wnt , Humanos , Neoplasias Colorretais/microbiologia , Serina-Treonina Quinases TOR/metabolismo , Projetos Piloto , Fosfatidilinositol 3-Quinases/metabolismo , Masculino , Feminino , Polipose Adenomatosa do Colo/microbiologia , Polipose Adenomatosa do Colo/genética , Pessoa de Meia-Idade , Proteína da Polipose Adenomatosa do Colo/genética , Proteína da Polipose Adenomatosa do Colo/metabolismo , Fezes/microbiologia , Microbioma Gastrointestinal , Idoso , Adulto , Mutação/genética , MicrobiotaRESUMO
BACKGROUND: Previous research has identified some tensions that public organizations may encounter during crises. However, there remains a scarcity of research examining how public health care organizations effectively navigate these tensions to reconcile the diverse interests, needs, and demands from various stakeholders. PURPOSES: The study seeks to shed light on the dynamics underlying the tensions experienced by public hospitals during the COVID-19 pandemic. It illustrates how different hospitals' actors have navigated these tensions, identifying solutions and approaches that fostered collaborative endeavors among internal and external stakeholders. METHODOLOGY: The study draws on qualitative analyses of 49 semistructured interviews and the notes from two focus groups involving key informants at one of the largest university hospitals in Italy. We also rely on the verbatim transcripts from meetings involving the members of the temporary emergency team constituting the taskforce. FINDINGS: The results highlight the tensions that emerged throughout the different waves of the COVID-19 pandemic and how various actors have managed them in a way to reconcile opposing forces while unleashing adaptability and creativity. PRACTICE IMPLICATIONS: Hospital managers would benefit from developing a paradoxical mindset for crisis preparedness, allowing them to embrace existing tensions and devise creative solutions to favor resilience and change.
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COVID-19 , Grupos Focais , Hospitais Universitários , Pandemias , Pesquisa Qualitativa , COVID-19/epidemiologia , Itália/epidemiologia , Humanos , Hospitais Universitários/organização & administração , Entrevistas como Assunto , SARS-CoV-2RESUMO
BACKGROUND AND AIMS: The terminal ileum is the most frequent site of Crohn's Disease (CD) that necessitates surgery. Of the postoperative complications (POCs) associated with ileocaecal resection for CD, intra-abdominal septic complications (IASCs) include anastomotic leak, abscesses, and entero-cutaneous fistula. We aimed to identify predictors of IASCs and severe POCs (Clavien-Dindo ≥3) after primary ileocaecal resection for CD. METHODS: This is a retrospective single-centre cohort study including all consecutive primary ileocaecal resection for CD in a tertiary IBD centre between 2004 and 2021. RESULTS: A total of 853 patients underwent primary ileocaecal resection for CD. 307 (36.6 %) patients were receiving antibiotics, 253 (29.8 %), systemic steroids, and 178 (21.0 %) oral budesonide at surgery. At 90 days, 260 (30.8 %) patients developed POCs, 62 (7.3 %) severe POCs, and 56 (6.6 %) IASCs. At multivariate analysis, severe POCs were associated with lower preoperative albumin levels (OR1.58, 95 %CI 1.02-2.50, p = 0.040) and a history of cardiovascular diseases (OR2.36, 95 %CI 1.08-7.84, p = 0.030). IASCs were associated with lower preoperative albumin levels (OR1.81, 95 %CI 1.15-2.94, p = 0.011) and oral budesonide (OR2.07, 95 %CI 1.12-3.83, p = 0.021) with a dose-dependent effect. CONCLUSIONS: The independent association, dose-dependent effect, and biological plausibility of budesonide and IASCs suggest a robust causal effect. Oral budesonide should be carefully assessed before primary ileocaecal resection for CD.
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Budesonida , Doença de Crohn , Íleo , Complicações Pós-Operatórias , Humanos , Estudos Retrospectivos , Masculino , Feminino , Doença de Crohn/cirurgia , Doença de Crohn/tratamento farmacológico , Adulto , Budesonida/administração & dosagem , Budesonida/efeitos adversos , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/epidemiologia , Pessoa de Meia-Idade , Íleo/cirurgia , Albumina Sérica/análise , Fatores de Risco , Administração Oral , Ceco/cirurgia , Fístula Anastomótica/etiologia , Análise Multivariada , Adulto Jovem , Sepse/etiologia , Sepse/sangue , Anti-Inflamatórios/administração & dosagem , Anti-Inflamatórios/efeitos adversosRESUMO
Ectopic liver (EL) is a rare congenital anomaly characterized by the presence of a mass composed of hepatic tissue localized in a different anatomical location with no connection to the native liver. Usually an incidental finding, EL can rarely cause symptoms such as abdominal pain due to torsion, intraperitoneal bleeding, compression, obstruction, or neoplastic transformation, both benign and malignant. EL is often suspected after instrumental investigations such as ultrasound, CT and MRI, however a definitive diagnosis is necessarily bioptic. Here we report a case of a 22-year-old Italian female patient with acute abdominal pain, who underwent abdominal ultrasound, CEUS with Sonovue®, CT scan and ultrasound-guided biopsy which raised the suspicion of hepatocellular adenoma (H-HCA). After a laparoscopic excision of the lesion a diagnosis of H-HCA was formulated.
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BACKGROUND: The association between volume, complications and pathological outcomes is still under debate regarding colorectal cancer surgery. The aim of the study was to assess the association between centre volume and severe complications, mortality, less-than-radical oncologic surgery, and indications for neoadjuvant therapy. METHODS: Retrospective analysis of 16,883 colorectal cancer cases from 80 centres (2018-2021). Outcomes: 30-day mortality; Clavien-Dindo grade >2 complications; removal of ≥ 12 lymph nodes; non-radical resection; neoadjuvant therapy. Quartiles of hospital volumes were classified as LOW, MEDIUM, HIGH, and VERY HIGH. Independent predictors, both overall and for rectal cancer, were evaluated using logistic regression including age, gender, AJCC stage and cancer site. RESULTS: LOW-volume centres reported a higher rate of severe postoperative complications (OR 1.50, 95% c.i. 1.15-1.096, P = 0.003). The rate of ≥ 12 lymph nodes removed in LOW-volume (OR 0.68, 95% c.i. 0.56-0.85, P < 0.001) and MEDIUM-volume (OR 0.72, 95% c.i. 0.62-0.83, P < 0.001) centres was lower than in VERY HIGH-volume centres. Of the 4676 rectal cancer patients, the rate of ≥ 12 lymph nodes removed was lower in LOW-volume than in VERY HIGH-volume centres (OR 0.57, 95% c.i. 0.41-0.80, P = 0.001). A lower rate of neoadjuvant chemoradiation was associated with HIGH (OR 0.66, 95% c.i. 0.56-0.77, P < 0.001), MEDIUM (OR 0.75, 95% c.i. 0.60-0.92, P = 0.006), and LOW (OR 0.70, 95% c.i. 0.52-0.94, P = 0.019) volume centres (vs. VERY HIGH). CONCLUSION: Colorectal cancer surgery in low-volume centres is at higher risk of suboptimal management, poor postoperative outcomes, and less-than-adequate oncologic resections. Centralisation of rectal cancer cases should be taken into consideration to optimise the outcomes.
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Procedimentos Cirúrgicos do Sistema Digestório , Neoplasias Retais , Humanos , Estudos Retrospectivos , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Neoplasias Retais/cirurgia , Neoplasias Retais/complicações , Procedimentos Cirúrgicos do Sistema Digestório/efeitos adversos , LinfonodosRESUMO
AIM: Local excision (LE) in selected cases after neoadjuvant radiochemotherapy (RCT) for locally advanced rectal cancer in clinically complete or major responders has been recently reported as an alternative to standard radical resection. Completion total mesorectal excision (cTME) is generally performed when high-risk pathological features are found in LE surgical specimens. The aim of this study was to evaluate the incidence of residual tumour and lymph node metastases after cTME in patients previously treated by RCT + LE. The secondary aims were to quantify the rate of postoperative morbidity and mortality and to evaluate the long-term oncological outcome of this group of patients. METHODS: All patients treated from 2007 to 2020 by LE for locally advanced rectal cancer with a clinically complete or major response to RCT who had a subsequent cTME for high-risk pathological factors (ypT >1 and/or TRG >2 and/or positive margins) were included in this multicentre retrospective study. Pathological data, postoperative short-term morbidity (classified according to Clavien-Dindo) and mortality and oncological long-term outcome after cTME were recorded in a database. Statistical analysis was performed using Wizard for iOS version 1.9.31. RESULTS: A total of 47 patients were included in the study. The rate of R0 resection was 95.7%, and a sphincter-saving procedure was performed in 37 patients (78.7%), with a protective stoma rate of 78.4%. In 28 cases (59.6%), it was possible to perform a minimally invasive approach. A residual tumour (pT and/or pN) on cTME specimens was found in 21 cases (44.7%). The rate of lymph node metastases was 12.8%. The overall short-term (within 30 days) postoperative morbidity was 34%, but grade >2 postoperative complications occurred in only nine patients (19.1%), with a reoperation rate of 6.4%. No short-term postoperative deaths occurred. At a median follow-up of 57 months (range: 21-174), the long-term stoma-free rate was 70.2%, and the actuarial 5-year overall survival (OS), disease-free survival (DFS) and local control (LC) were 86.7%, 88.9% and 95.7%, respectively. CONCLUSION: When patients exhibit high-risk pathological factors after RCT + LE, cTME should be suggested due to the high risk of residual tumour or lymph node involvement (44.7%). The results after cTME in terms of the rate of R0 resection, sphincter-saving procedure, postoperative morbidity and mortality and long-term oncological outcome seem to be acceptable and do not represent a contraindication to use LE as a first-step treatment in patients with major or complete clinical response after RCT.
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Terapia Neoadjuvante , Neoplasias Retais , Humanos , Terapia Neoadjuvante/efeitos adversos , Metástase Linfática , Neoplasia Residual/tratamento farmacológico , Neoplasia Residual/etiologia , Neoplasia Residual/patologia , Resultado do Tratamento , Neoplasias Retais/cirurgia , Neoplasias Retais/tratamento farmacológico , Quimiorradioterapia , Recidiva Local de Neoplasia/patologia , Estadiamento de NeoplasiasRESUMO
INTRODUCTION: As robotic surgery increases its reach, novel platforms are being released. We present the first 17 consecutive cases of alimentary tract surgery performed with the HugoTM RAS (Medtronic). METHODS: patients were selected to undergo surgery from February through April 2023. Exclusion criteria were age <16 years, BMI>60, ASA IV. RESULTS: 17 patients underwent ileocaecal resection for Chrons disease (2 M and 1 F) and pseudo-obstruction of the terminal ileum (1 M), cholecystectomy (3 M and 5 F), subtotal gastrectomy with D2 lymphadenectomy (1 F), sleeve gastrectomy (1 F), hiatal hernia repair with Nissen fundoplication (1 M), right hemicolectomy (1 M) and sigmoidectomy (1 M). No conversion to an open approach or any arm collisions requiring corrective actions were reported. CONCLUSIONS: Our preliminary experience with the HugoTM RAS point to safety and feasibility for a rather wide spectrum of surgical procedures of the alimentary tract.
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Hérnia Hiatal , Laparoscopia , Procedimentos Cirúrgicos Robóticos , Robótica , Humanos , Adolescente , Procedimentos Cirúrgicos Robóticos/métodos , Estudos de Viabilidade , Fundoplicatura/métodos , Gastrectomia , Laparoscopia/métodos , Estudos Retrospectivos , Resultado do Tratamento , Hérnia Hiatal/cirurgiaRESUMO
Correct tumour restaging is pivotal for identifying the most personalised surgical treatment for patients with locally advanced rectal cancer undergoing neoadjuvant therapy, and works to avoid both poor oncological outcome and overtreatment. Digital rectal examination, endoscopy, and pelvic magnetic resonance imaging are the recommended modalities for local tumour restaging, while chest and abdominal computed tomography are utilised for the assessment of distant disease. The optimal length of time between neoadjuvant treatment and restaging, in terms of both oncological safety and clinical effectiveness of treatment, remains unclear, especially for patients receiving prolonged total neoadjuvant therapy. The timely identification of patients who are radioresistant and at risk of disease progression remains challenging.
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OBJECTIVES: Therapeutic drug monitoring (TDM) may be helpful in tailoring antimicrobial treatment, and expert interpretation of the results may make it more clinically useful. METHODS: This study aimed to assess retrospectively the first-year impact (July 2021 to June 2022) of a newly established expert clinical pharmacological advice (ECPA) programme based on TDM results in tailoring therapy with 18 antimicrobials hospital-wide in a tertiary university hospital. All patients having ≥1 ECPA were grouped in five cohorts [haematology, intensive care unit (ICU), paediatrics, medical wards and surgical wards]. Four indicators of performance were identified: total ECPAs; total ECPAs recommending dosing adjustments/total ECPAs both at first and at subsequent assessments; and turnaround time (TAT) of ECPAs, defined as optimal (<12 h), quasi-optimal (12-24 h), acceptable (24-48 h) or suboptimal (>48 h). RESULTS: A total of 8484 ECPAs were provided for tailoring treatment in 2961 patients, mostly admitted in the ICU (34.1%) and medical wards (32.0%). The proportion of ECPAs recommending dosing adjustments was >40% at first assessment (40.9% haematology; 62.9% ICU; 53.9% paediatrics; 59.1% medical wards; and 59.7% surgical wards), and decreased consistently at subsequent TDM assessments (20.7% haematology; 40.6% ICU; 37.4% paediatrics; 32.9% medical wards; and 29.2% surgical wards). The overall median TAT of the ECPAs was optimal (8.11 h). CONCLUSION: The TDM-guided ECPA programme was successful in tailoring treatment with a wide panel of antimicrobials hospital-wide. Expert interpretation by medical clinical pharmacologists, short TATs, and strict interaction with infectious diseases consultants and clinicians were crucial in achieving this.
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Anti-Infecciosos , Monitoramento de Medicamentos , Humanos , Criança , Monitoramento de Medicamentos/métodos , Estudos Retrospectivos , Anti-Infecciosos/uso terapêutico , Centros de Atenção Terciária , Hospitais UniversitáriosRESUMO
Locally Recurrent Rectal Cancer (LRRC) remains a major clinical concern; it rapidly invades pelvic organs and nerve roots, causing severe symptoms. Curative-intent salvage therapy offers the only potential for cure but it has a higher chance of success when LRRC is diagnosed at an early stage. Imaging diagnosis of LRRC is very challenging due to fibrosis and inflammatory pelvic tissue, which can mislead even the most expert reader. This study exploited a radiomic analysis to enrich, through quantitative features, the characterization of tissue properties, thus favoring an accurate detection of LRRC by Computed Tomography (CT) and 18F-FDG-Positron Emission Tomography/CT (PET/CT). Of 563 eligible patients undergoing radical resection (R0) of primary RC, 57 patients with suspected LRRC were included, 33 of which were histologically confirmed. After manually segmenting suspected LRRC in CT and PET/CT, 144 Radiomic Features (RFs) were generated, and RFs were investigated for univariate significant discriminations (Wilcoxon rank-sum test, p < 0.050) of LRRC from NO LRRC. Five RFs in PET/CT (p < 0.017) and two in CT (p < 0.022) enabled, individually, a clear distinction of the groups, and one RF was shared by PET/CT and CT. As well as confirming the potential role of radiomics to advance LRRC diagnosis, the aforementioned shared RF describes LRRC as tissues having high local inhomogeneity due to the evolving tissue's properties.
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BACKGROUND: Anastomotic leak (AL) remains one of the most relevant complications after intestinal resection for Crohn's disease (CD). While surgery has always been considered the standard treatment for perianastomotic collection, percutaneous drainage (PD) has been proposed as a potential alternative. METHODS: Retrospective study in consecutive patients treated with either PD or surgery for AL after intestinal resection for CD between 2004 and 2022. AL was defined as a perianastomotic fluid collection confirmed by radiological findings. Patients with generalized peritonitis or clinical instability were excluded. PRIMARY AIM: To compare the success rate of PD vs. surgery. Secondary aims: To compare the outcomes at 90 days after the procedures; to identify the variables associated with the indication for PD. RESULTS: A total of 47 patients were included, of which 25 (53%) underwent PD and 22 (47%) surgery. The success rate was 84% in the PD and 95% in the surgery group (p = 0.20). There were no significant differences between the PD and surgery group in postoperative medical and surgical complications, discharge, readmission or reoperation rates at 90 days. PD was more likely to be performed in patients with later diagnosis of AL (OR 1.25, 95% CI 1.03-1.53, p = 0.027), undergoing ileo-colic anastomosis alone (OR 3.72, 95% CI 2.29-12.45, p = 0.034) and treated after 2016 (OR 6.36, 95% CI 1.04-39.03, p = 0.046). CONCLUSION: The present study suggests that PD is a safe and effective procedure to treat anastomotic leak and perianastomotic collection in CD patients. PD should be indicated in all eligible patients as an effective alternative to surgery.
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The pelvic anatomy poses great challenges to orthopedic surgeons. Sarcomas are often large in size and typically enclosed in the narrow confines of the pelvis with the close proximity of vital structures. The aim of this study is to report a systematic planned multidisciplinary surgical approach to treat pelvic sarcomas. Seventeen patients affected by bone and soft tissue sarcomas of the pelvis, treated using a planned multidisciplinary surgical approach, combining the expertise of orthopedic oncology and other surgeons (colleagues from urology, vascular surgery, abdominal surgery, gynecology and plastic surgery), were included. Seven patients were treated with hindquarter amputation; 10 patients underwent excision of the tumor. Reconstruction of bone defects was conducted in six patients with a custom-made 3D-printed pelvic prosthesis. Thirteen patients experienced at least one complication. Well-organized multidisciplinary collaborations between each subspecialty are the cornerstone for the management of patients affected by pelvic sarcomas, which should be conducted in specialized centers. A multidisciplinary surgical approach is of paramount importance in order to obtain the best successful surgical results and adequate margins for achieving acceptable outcomes.
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Neoplasias Pélvicas , Sarcoma , Humanos , Neoplasias Pélvicas/cirurgia , Neoplasias Pélvicas/patologia , Resultado do Tratamento , Pelve/cirurgia , Sarcoma/patologiaRESUMO
PURPOSE: To evaluate the pathological complete response (pCR) rate of locally advanced rectal cancer (LARC) after adaptive high-dose neoadjuvant chemoradiation (CRT) based on 18 F-fluorodeoxyglucose positron emission tomography/computed tomography (18 F-FDG-PET/CT). METHODS: The primary endpoint was the pCR rate. Secondary endpoints were the predictive value of 18 F-FDG-PET/CT on pathological response and acute and late toxicity. All patients performed 18 F-FDG-PET/CT at baseline (PET0) and after 2 weeks during CRT (PET1). The metabolic PET parameters were calculated both at the PET0 and PET1. The total CRT dose was 45 Gy to the pelvic lymph nodes and 50 Gy to the primary tumor, corresponding mesorectum, and to metastatic lymph nodes. Furthermore, a sequential boost was delivered to a biological target volume defined by PET1 with an additional dose of 5 Gy in 2 fractions. Capecitabine (825 mg/m2 twice daily orally) was prescribed for the entire treatment duration. RESULTS: Eighteen patients (13 males, 5 females; median age 55 years [range, 41-77 years]) were enrolled in the trial. Patients underwent surgical resection at 8-9 weeks after the end of neoadjuvant CRT. No patient showed grade > 1 acute radiation-induced toxicity. Seven patients (38.8%) had TRG = 0 (complete regression), 5 (27.0%) showed TRG = 2, and 6 (33.0%) had TRG = 3. Based on the TRG results, patients were classified in two groups: TRG = 0 (pCR) and TRG = 1, 2, 3 (non pCR). Accepting p < 0.05 as the level of significance, at the Kruskal-Wallis test, the medians of baseline-MTV, interim-SUVmax, interim-SUVmean, interim-MTV, interim-TLG, and the MTV reduction were significantly different between the two groups. 18 F-FDG-PET/CT was able to predict the pCR in 77.8% of cases through compared evaluation of both baseline PET/CT and interim PET/CT. CONCLUSIONS: Our results showed that a dose escalation on a reduced target in the final phase of CRT is well tolerated and able to provide a high pCR rate.
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Tomografia por Emissão de Pósitrons combinada à Tomografia Computadorizada , Neoplasias Retais , Masculino , Feminino , Humanos , Pessoa de Meia-Idade , Fluordesoxiglucose F18 , Compostos Radiofarmacêuticos , Neoplasias Retais/diagnóstico por imagem , Neoplasias Retais/terapia , Neoplasias Retais/patologia , Quimiorradioterapia/efeitos adversos , Tomografia por Emissão de Pósitrons , Terapia Neoadjuvante/efeitos adversos , Resultado do TratamentoRESUMO
BACKGROUND: Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) is the pathogen responsible for pandemic coronavirus disease 2019 (COVID-19). It is a highly contagious virus which primarily affects the respiratory tract, nevertheless, the lungs are not the only target organs of the virus. The intestinal tract could represent an additional tropism site for SARS-CoV-2. Several observations have collectively suggested that enteric infections can occur in COVID-19 patients. However, the detection of viral RNA in gastrointestinal (GI) tissue samples has not been adequately investigated and results are conflicting. AIM: To detect the presence of SARS-CoV-2 RNA in intestinal mucosa samples and to evaluate histological features. METHODS: The COVID-19 patients hospitalized at an Italian tertiary hospital from April 2020 to March 2021 were evaluated for enrollment in an observational, monocentric trial. The study population was composed of two groups of adult patients. In the first group (biopsy group, 30 patients), patients were eligible for inclusion if they had mild to moderate disease and if they agreed to have a rectal biopsy; in the second group (surgical specimen group, 6 patients), patients were eligible for inclusion if they underwent intestinal resection during index hospitalization. Fifty-nine intestinal mucosal samples were analyzed. RESULTS: Viral RNA was not detectable in any of the rectal biopsies performed (0/53). Histological examination showed no enterocyte damage, but slight edema of the lamina propria with mild inflammatory lymphoplasmacytic infiltration. There was no difference in inflammatory infiltrates in patients with and without GI symptoms. SARS-CoV-2 RNA was detected in fecal samples in 6 cases out of 14 cases examined (42.9%). In the surgical specimen group, all patients underwent emergency intestinal resection. Viral RNA was detected in 2 surgical specimens of the 6 examined, both of which were from patients with active neoplastic disease. Histological examination also pointed out abundant macrophages, granulocytes and plasma cells infiltrating the muscular layer and adipose tissue, and focal vasculitis. CONCLUSION: Mild-moderate COVID-19 may not be associated with rectal infection by the virus. More comprehensive autopsies or surgical specimens are needed to provide histological evidence of intestinal infection.
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COVID-19 , Adulto , Humanos , Intestinos , Pacientes , RNA Viral , SARS-CoV-2RESUMO
Importance: Delays in screening programs and the reluctance of patients to seek medical attention because of the outbreak of SARS-CoV-2 could be associated with the risk of more advanced colorectal cancers at diagnosis. Objective: To evaluate whether the SARS-CoV-2 pandemic was associated with more advanced oncologic stage and change in clinical presentation for patients with colorectal cancer. Design, Setting, and Participants: This retrospective, multicenter cohort study included all 17â¯938 adult patients who underwent surgery for colorectal cancer from March 1, 2020, to December 31, 2021 (pandemic period), and from January 1, 2018, to February 29, 2020 (prepandemic period), in 81 participating centers in Italy, including tertiary centers and community hospitals. Follow-up was 30 days from surgery. Exposures: Any type of surgical procedure for colorectal cancer, including explorative surgery, palliative procedures, and atypical or segmental resections. Main Outcomes and Measures: The primary outcome was advanced stage of colorectal cancer at diagnosis. Secondary outcomes were distant metastasis, T4 stage, aggressive biology (defined as cancer with at least 1 of the following characteristics: signet ring cells, mucinous tumor, budding, lymphovascular invasion, perineural invasion, and lymphangitis), stenotic lesion, emergency surgery, and palliative surgery. The independent association between the pandemic period and the outcomes was assessed using multivariate random-effects logistic regression, with hospital as the cluster variable. Results: A total of 17â¯938 patients (10â¯007 men [55.8%]; mean [SD] age, 70.6 [12.2] years) underwent surgery for colorectal cancer: 7796 (43.5%) during the pandemic period and 10â¯142 (56.5%) during the prepandemic period. Logistic regression indicated that the pandemic period was significantly associated with an increased rate of advanced-stage colorectal cancer (odds ratio [OR], 1.07; 95% CI, 1.01-1.13; P = .03), aggressive biology (OR, 1.32; 95% CI, 1.15-1.53; P < .001), and stenotic lesions (OR, 1.15; 95% CI, 1.01-1.31; P = .03). Conclusions and Relevance: This cohort study suggests a significant association between the SARS-CoV-2 pandemic and the risk of a more advanced oncologic stage at diagnosis among patients undergoing surgery for colorectal cancer and might indicate a potential reduction of survival for these patients.