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1.
Int J Surg ; 2024 Apr 03.
Artigo em Inglês | MEDLINE | ID: mdl-38573078

RESUMO

INTRODUCTION: Duodenal neuroendocrine tumours (D-NETs) have a low incidence; however, their diagnosis has been increasing. Features such as tumour location, size, type, histological grade, and stage were used to adapt the treatment to either endoscopic (ER) or surgical (SR) resections. There is no consensus regarding the definitive treatment. The authors' study aimed to describe the management of non-metastatic, well-differentiated D-NETs in France and its impact on patient survival. METHODS: A registry-based multicenter study using prospectively collected data between 2000 and 2019, including all patients managed for non-metastatic G1 and G2 D-NETs, was conducted in the GTE group. RESULTS: A total of 153 patients were included. Fifty-eight benefited from an ER, and 95 had an SR. No difference in recurrence-free survival (RFS) was observed regardless of treatment type. There was no significant difference between the two groups (ER vs. SR) in terms of location, size, grade, or lymphadenopathy, regardless of the type of incomplete resection performed or regarding the pre-therapeutic assessment of lymph node invasion in imaging. The surgery allowed for significantly more complete resection (patients with R1 resection in the SR group: 9 vs. 14 in the ER group, P<0.001). Among the 51 patients with positive lymph node dissection after SR, tumour size was less than or equal to 1 cm in 25 cases. Surgical complications were more numerous (P=0.001). In the sub-group analysis of G1-G2 D-NETs between 11 and 19 mm, there was no significant difference in grade (P=0.977) and location (P=0.617) between the two groups (ER vs. SR). No significant difference was found in both morphological and functional imaging, focusing on the pre-therapeutic assessment of lymph node invasion (P=0.387). CONCLUSION: Regardless of the resection type (ER or SR) of G1-G2 non-metastatic D-NETs, as well as the type of management of incomplete resection, which was greater in the ER group, long-term survival results were similar between ER and SR. Organ preservation seems to be the best choice owing to the slow evolution of these tumours.

2.
Eur J Surg Oncol ; 50(6): 108310, 2024 Mar 28.
Artigo em Inglês | MEDLINE | ID: mdl-38598874

RESUMO

BACKGROUND: Although several prognostic factors in GIST have been well studied such as tumour size, mitotic rate, or localization, the influence of microscopic margins or R1 resection remains controversial. The aim of this study was to evaluate the influence of R1 resection on the prognosis of GIST in a large multicentre retrospective series of patients. METHODS: From 2001 to 2013, 1413 patients who underwent surgery for any site of GIST were identified from 61 European centers. 1098 patients were included, excluding synchronous metastases, concurrent malignancies, R2 resection or GIST recurrence. Tumour rupture (TR) was reclassified according to the Oslo sarcoma classification. Cox proportional hazards ratio and Kaplan-Meier survival estimates were used to analyse 5-year recurrence-free survival (RFS). RESULTS: Of 1098 patients, 38 (3%) underwent R1 resection with a risk of TR of 11%. The 5-year RFS was 89.6% with a median follow-up of 81 months [range: 31.2-152 months]. On univariate analysis, lower RFS was significantly associated with R1 resection [HR = 2.13; p = 0.04], high risk score according to the modified NIH classification, administration of adjuvant therapy [HR = 2.24; p < 0.001] and intraoperative complications [HR = 2.82; p < 0.001]. Only intraoperative complications [HR = 1.79; p = 0.02] and high risk according to the modified NIH classification including the updated definition of TR [HR = 3.43; p = 0.04] remained significant on multivariate analysis. CONCLUSION: This study shows that positive microscopic margins are not an independent predictive factor for RFS in GIST when taking into account the up-dated classification of TR. R1 resection may be considered a reasonable alternative to avoid major functional sequelae and should not lead to reoperation.

4.
Ann Surg Oncol ; 31(6): 3984-3994, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38485867

RESUMO

BACKGROUND: French policymakers recently chose to regulate high-risk digestive cancer surgery (DCS). A minimum of five cases per year should be performed for each of the following types of curative cancer surgery: esophagus/esogastric junction (ECS), stomach (GCS), liver (LCS, metastasis included), pancreas (PCS), and rectum (RCS). This study aimed to evaluate the hypothetical beneficial effects of the new legal minimal volume thresholds on the rates of 90-day postoperative mortality (90POM) for each high-risk DCS. METHODS: This nationwide observational population-based cohort study used data extracted from the French National Health Insurance Database from 1 January 2015-31 December 2017. Mixed-effects logistic regression models were performed to estimate the independent effect of hospital volume. RESULTS: During the study period, 61,169 patients (57.1 % male, age 69.7 ±12.2 years) underwent high-risk DCS including ECS (n = 4060), GCS (n = 5572), PCS (n = 8598), LCS (n = 10,988), and RCS (n = 31,951), with 90POM of 6.6 %, 6.9 %, 6.0 %, 5.2 %, and 2.9 %, respectively. For hospitals fulfilling the new criteria, 90POM was lower after adjustment only for LCS (odds ratio [OR],15.2; 95 % confidence interval [CI], 9.5-23.2) vs OR, 7.6; 95 % CI, 5.2-11.0; p < 0.0001) and PCS (OR, 3.6; 95 % CI, 1.7-7.6 vs OR, 2.1; 95 % CI, 1.0-4.4; p<0.0001). With higher thresholds, all DCSs showed a lower adjusted risk of 90POM (e.g., OR, 0.38; 95 % CI, 0.28-0.51) for PCS of 40 or higher. CONCLUSION: Based on retrospective data, thresholds higher than those promulgated would better improve the safety of high-risk DCS. New policies aiming to further centralize high-risk DCS should be considered, associated with a clear clinical pathway of care for patients to improve accessibility to complex health care in France.


Assuntos
Neoplasias do Sistema Digestório , Procedimentos Cirúrgicos do Sistema Digestório , Complicações Pós-Operatórias , Humanos , Masculino , Feminino , Idoso , Neoplasias do Sistema Digestório/cirurgia , Neoplasias do Sistema Digestório/mortalidade , França/epidemiologia , Procedimentos Cirúrgicos do Sistema Digestório/mortalidade , Procedimentos Cirúrgicos do Sistema Digestório/efeitos adversos , Taxa de Sobrevida , Seguimentos , Prognóstico , Pessoa de Meia-Idade , Auditoria Médica , Hospitais com Alto Volume de Atendimentos/estatística & dados numéricos , Fatores de Risco
5.
Int J Surg ; 110(3): 1519-1526, 2024 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-38079593

RESUMO

BACKGROUND: Venous thromboembolism (VTE) is a well-recognized complication following gastrointestinal cancer surgery, particularly early postoperatively. The incidence and risk factors of VTE within 1-year after esophageal (including esophago-gastric junction) (ECS) and gastric (GCS) cancer surgeries, and especially its impact on 1-year global mortality, are yet under-explored. METHODS: This nationwide observational population-based cohort study used data extracted from all patients undergoing ECS and GCS in France between 1 January 2015 and 31 December 2017. Multivariate logistic regression was used to identify risk factors for 90 postoperative days (POD) VTE (OR 95% CI). Cox proportional hazards models investigated the impact of 1-year postoperative VTE on 1-year global mortality [HR (95% CI)]. RESULTS: During the study period, 8005 patients underwent ECS ( N =3429) or GCS ( N =4576) (31.8% female; 66.7±12.1 years old). Majority ( N =4951) of patients had preoperative treatment (chemotherapy or radiochemotherapy). Ninety POD incidence of VTE were 4.7% (ECS=6.2%) (GCS=3.6%) (44.7% during first hospitalization, 19.0% needing readmission, and 36.3% ambulatory management). Main risk factors were three and two field esophagectomy [3.6 (2.20-5.83) and 2.2 (1.68-3.0)], obesity [1.9 (1.40-2.58)] and history of VTE [5.1 (2.72-9.45)]. Late-onset VTE rates (occurring between the 6th and 12th month) represented 1.80 and 1.46% of the overall ECS and GCS groups. Patients with VTE within 1-year had higher risks of 1-year global mortality: (2.04 1.52; 2.73) and 2.71 (2.09; 3.51), respectively. CONCLUSION: Our extensive analysis of a nationwide database highlights the significant risk of postoperative VTE after ECS and GCS, persisting within 90 POD and up to 1-year. Crucially, a higher risk of global mortality within 1-year for patients experiencing early or late VTE was found. These findings could advocate for further research into extended prophylactic regimens, particularly for those most at risk.


Assuntos
Neoplasias , Tromboembolia Venosa , Humanos , Feminino , Pessoa de Meia-Idade , Idoso , Masculino , Tromboembolia Venosa/epidemiologia , Tromboembolia Venosa/etiologia , Tromboembolia Venosa/prevenção & controle , Estudos de Coortes , Neoplasias/complicações , Fatores de Risco , Obesidade/complicações , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/prevenção & controle , Incidência
6.
Pharmaceutics ; 15(2)2023 Feb 16.
Artigo em Inglês | MEDLINE | ID: mdl-36839986

RESUMO

Apixaban and rivaroxaban have first-line use for many patients needing anticoagulation for venous thromboembolism (VTE). The pharmacokinetics of these drugs in non-obese subjects have been extensively studied, and, while changes in pharmacokinetics have been documented in obese patients, data remain scarce for these anticoagulants. The aim of this study was to perform an external validation of published population pharmacokinetic (PPK) models of apixaban and rivaroxaban in a cohort of obese patients with VTE. A literature search was conducted in the PubMed/MEDLINE, Scopus, and Embase databases following the PRISMA statement. External validation was performed using MonolixSuite software, using prediction-based and simulation-based diagnostics. An external validation dataset from the university hospitals of Brest and Rennes, France, included 116 apixaban pharmacokinetic samples from 69 patients and 121 rivaroxaban samples from 81 patients. Five PPK models of apixaban and 16 models of rivaroxaban were included, according to the inclusion criteria of the study. Two of the apixaban PPK models presented acceptable performances, whereas no rivaroxaban PPK model did. This study identified two published models of apixaban applicable to apixaban in obese patients with VTE. However, none of the rivaroxaban models evaluated were applicable. Dedicated studies appear necessary to elucidate rivaroxaban pharmacokinetics in this population.

7.
Thromb Haemost ; 123(4): 393-401, 2023 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-36535657

RESUMO

BACKGROUND: Previous studies have reported inconsistent findings regarding the association between obstructive sleep apnea (OSA) and incident venous thromboembolism (VTE). More specifically, the association between OSA and unprovoked VTE was barely evaluated. We aimed to evaluate whether apnea hypopnea index (AHI) and nocturnal hypoxemia markers were associated with unprovoked VTE incidence in patients investigated for OSA. MATERIAL AND METHODS: Data from the Pays de la Loire Sleep Cohort were linked to the French health administrative data to identify incident unprovoked VTE in patients suspected for OSA and no previous VTE disease. Cox proportional hazards models were used to evaluate the association of unprovoked VTE incidence with AHI and nocturnal hypoxemia markers including the time spent under 90% of saturation (T90), oxygen desaturation index, and hypoxic burden (HB), a more specific marker of respiratory events related to hypoxia. The impact of continuous positive airway pressure (CPAP) was evaluated in the subgroup of patients who were proposed the treatment. RESULTS: After a median [interquartile range] follow-up of 6.3 [4.3-9.0] years, 104 of 7,355 patients developed unprovoked VTE, for an incidence rate of 10.8 per 1,000 patient-years. In a univariate analysis, T90 and HB predicted incident VTE. In the fully adjusted model, T90 was the only independent predictor (hazard ratio: 1.06; 95% confidence interval: [1.01-1.02]; p = 0.02). The CPAP treatment has no significant impact on VTE incidence. CONCLUSION: Patients with more severe nocturnal hypoxia are more likely to have incident unprovoked VTE.


Assuntos
Síndromes da Apneia do Sono , Apneia Obstrutiva do Sono , Tromboembolia Venosa , Humanos , Tromboembolia Venosa/diagnóstico , Tromboembolia Venosa/epidemiologia , Tromboembolia Venosa/complicações , Síndromes da Apneia do Sono/complicações , Apneia Obstrutiva do Sono/complicações , Apneia Obstrutiva do Sono/diagnóstico , Apneia Obstrutiva do Sono/epidemiologia , Hipóxia/complicações , Sono
8.
Ann Surg ; 276(5): 830-837, 2022 11 01.
Artigo em Inglês | MEDLINE | ID: mdl-35856494

RESUMO

OBJECTIVE: To describe the management of pathogenic CDH1 variant carriers (pCDH1vc) within the FREGAT (FRench Eso-GAsTric tumor) network. Primary objective focused on clinical outcomes and pathological findings, Secondary objective was to identify risk factor predicting postoperative morbidity (POM). BACKGROUND: Prophylactic total gastrectomy (PTG) remains the recommended option for gastric cancer risk management in pCDH1vc with, however, endoscopic surveillance as an alternative. METHODS: A retrospective observational multicenter study was carried out between 2003 and 2021. Data were reported as median (interquartile range) or as counts (proportion). Usual tests were used for univariate analysis. Risk factors of overall and severe POM (ie, Clavien-Dindo grade 3 or more) were identified with a binary logistic regression. RESULTS: A total of 99 patients including 14 index cases were reported from 11 centers. Median survival among index cases was 12.0 (7.6-16.4) months with most of them having peritoneal carcinomatosis at diagnosis (71.4%). Among the remaining 85 patients, 77 underwent a PTG [median age=34.6 (23.7-46.2), American Society of Anesthesiologists score 1: 75%] mostly via a minimally invasive approach (51.9%). POM rate was 37.7% including 20.8% of severe POM, with age 40 years and above and low-volume centers as predictors ( P =0.030 and 0.038). After PTG, the cancer rate on specimen was 54.5% (n=42, all pT1a) of which 59.5% had no cancer detected on preoperative endoscopy (n=25). CONCLUSIONS: Among pCDH1vc, index cases carry a dismal prognosis. The risk of cancer among patients undergoing PTG remained high and unpredictable and has to be balanced with the morbidity and functional consequence of PTG.


Assuntos
Mutação em Linhagem Germinativa , Neoplasias Gástricas , Adulto , Antígenos CD , Caderinas/genética , Gastrectomia , Heterozigoto , Humanos , Pessoa de Meia-Idade , Estudos Retrospectivos , Neoplasias Gástricas/genética , Neoplasias Gástricas/patologia , Neoplasias Gástricas/cirurgia , Adulto Jovem
9.
Rev Prat ; 72(2): 176-177, 2022 Feb.
Artigo em Francês | MEDLINE | ID: mdl-35289527

RESUMO

VENOUS THROMBOEMBOLIC RISK AFTER BARIATRIC surgeryvenous thromboembolism is widely considered as the first medical postoperative complication after bariatric surgery with a rate around 0.5% during the first 90 postoperative days. Pulmonary embolism is often associated With septic complication, increasing the risk of postoperative death. Chemoprophylaxis with a minimum lenght of 10 days remains the corner stone of preventive treatment.


Risque thromboembolique veineux après une chirurgie bariatrique La maladie thromboembolique veineuse est la première complication médicale postopératoire de la chirurgie bariatrique, dont la mortalité est dominée par le risque d'embolie pulmonaire, souvent associé à une complica¬tion chirurgicale septique. Avec une incidence de 0,5 % dans les 90 jours, elle reste tout de même une compli¬cation rare mais qui peut se déclarer après la sortie du patient. Sa prévention repose toujours sur une mobili¬sation précoce et une thromboprophylaxie d'au moins 10 jours.


Assuntos
Cirurgia Bariátrica , Tromboembolia , Cirurgia Bariátrica/efeitos adversos , Quimioprevenção , Humanos , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/prevenção & controle , Veias
10.
Obes Rev ; 23(5): e13420, 2022 05.
Artigo em Inglês | MEDLINE | ID: mdl-35040249

RESUMO

While research publications on bariatric surgery (BS) have grown significantly over the past decade, there is no mapping of the existing body of evidence on this field of research. We performed a systematic review followed by a mapping of randomized controlled trials (RCTs) in BS for people with obesity. From January 2020 to December 2020, we performed a systematic review of RCTs evaluating BS, versus another surgical procedure, or versus a medical control group, through a search of Embase and PubMed. There was no restriction on outcomes for study selection. A total of 114 RCTs were included, most (73.7%) of which were based on a comparison with Roux-en-Y gastric bypass (RYGB) and conducted between 2010 and 2020. Only 15% of the trials were multicenter and few (3.5%) were international. The median number of patients enrolled was 61 (interquartile range [IQR]: 47.3-100). Follow-up time was 1 to 2 years in 36% and 22.8% of the trials, respectively. Weight loss was the most studied criterion (87% of RCTs), followed by obesity-related diseases, and medical and surgical complications (73%, 54%, and 47% of RCTs, respectively). Nutritional deficiency frequency, body composition, and mental health were little studied (20%, 18% and 5% of RCTs, respectively). Our literature review revealed that much research in BS is wasted because of replication of RCTs on subjects for which there is already body of evidence, with small populations and follow-up times mostly below 2 years. Yet several research questions remain unaddressed, and there are few long-term trials. Future studies should take into account the experience of the past 70 years of research in this field.


Assuntos
Cirurgia Bariátrica , Derivação Gástrica , Obesidade Mórbida , Cirurgia Bariátrica/métodos , Gastrectomia/métodos , Derivação Gástrica/métodos , Humanos , Estudos Multicêntricos como Assunto , Obesidade/cirurgia , Obesidade Mórbida/cirurgia , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento
11.
J Clin Epidemiol ; 139: 87-95, 2021 11.
Artigo em Inglês | MEDLINE | ID: mdl-34004338

RESUMO

OBJECTIVES: To systematically identify the strategy and frequency of spin in reports of bariatric surgery randomized controlled trials (RCTs) with statistically nonsignificant primary endpoint. STUDY DESIGN AND SETTING: The use of specific reporting strategies to highlight the beneficial effect of an experimental treatment can affect the reader interpretation of trial results, particularly when the primary endpoint is not statistically significant. A literature search was performed to identify RCTs publications assessing the impact of bariatric surgery on obesity-related comorbidities published over the past 10 years (from January 2020 till December 2020) in MEDLINE and EMBASE. RCTs publications with statistically non-significant primary outcomes were included. RESULTS: Of 46 576 reports screened for title and abstract inclusion, 29 RCT reports met the inclusion criteria for spin analysis. In total, 16 abstracts (55%) and 18 main texts (62%) were classified as having a spin. In abstract results and conclusion sections, the spin was identified in 69% of reports. In main text results, discussion, and conclusion sections, the spin was recognized in 37%, 72%, and 76% of reports respectively. The spin consisted mainly of focusing on within-group improvements and the interpretation of statistically nonsignificant results as showing treatment equivalence. CONCLUSION: Spin occurred in a high proportion of bariatric surgery RCTs with a statistically nonsignificant primary endpoint.


Assuntos
Cirurgia Bariátrica/psicologia , Cirurgia Bariátrica/estatística & dados numéricos , Interpretação Estatística de Dados , Obesidade/cirurgia , Viés de Publicação/estatística & dados numéricos , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Relatório de Pesquisa/normas , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade
12.
Fundam Clin Pharmacol ; 35(1): 53-61, 2021 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-32621292

RESUMO

The prevalence of obesity has been steadily increasing in recent years worldwide. At the same time bariatric surgery, the best therapeutic strategy to date in terms of sustainable weight loss and improvement of associated comorbidities has been also increasing. However, these surgeries, whether primarily restrictive or malabsorptive, raise questions about the pharmacology of oral drugs. Among widely used drugs, anticoagulants are the referent therapy to treat some cardiovascular diseases such as atrial fibrillation and venous thromboembolism. How bariatric surgery may impact pharmacological properties of oral anticoagulants, and more specifically, direct oral anticoagulants (DOACs) are difficult to anticipate. In this review, we describe available data concerning the potential impact of bariatric surgery on the pharmacology of oral anticoagulants. The vitamin K antagonists (VKAs) requirements for the same international normalized ratio target are reduced after bariatric surgery. Limited data available for dabigatran 150 mg twice daily indicate a risk of insufficient efficacy in atrial fibrillation after gastric bypass due to probable impaired absorption. Data for rivaroxaban at the prophylactic dose of 10 mg per day suggest no impact of bariatric surgery from 3 days to 8 months post-surgery. However, no conclusive data are available for other anticoagulants or the use of DOACs at therapeutic doses. To date, DOACs are not recommended in patients who have undergone bariatric surgery, because of limited available data. Pending new studies to confirm the predictable pharmacokinetics and safety of DOACs in this population, especially at therapeutic doses, VKAs remain the first option for chronic anticoagulation.


Assuntos
Anticoagulantes/farmacologia , Cirurgia Bariátrica , Administração Oral , Anticoagulantes/farmacocinética , Cirurgia Bariátrica/métodos , Humanos , Guias de Prática Clínica como Assunto , Vitamina K/antagonistas & inibidores
13.
Surg Obes Relat Dis ; 16(9): 1275-1282, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-32654896

RESUMO

BACKGROUND: While the benefits of bariatric surgery (BS) on pregnancy outcomes have been demonstrated for women compared with matched controls on presurgery body mass index (pB-BMI), data are lacking and those benefits are uncertain compared with matched controls on prepregnancy BMI (pP-BMI). OBJECTIVES: Our study aimed to evaluate outcomes (obstetrical and neonatal) of single pregnancy in women previously exposed to BS compared with women unexposed to BS matched on pB-BMI and pP-BMI. SETTINGS: Retrospective matched cohort study from 2 observational studies of pregnant women conducted in a French administrative county (Finistère). METHODS: From April 1, 2015 to January 31, 2019, pregnant women with previous BS (n = 52) were included and compared with 2 different control groups as follows: group A (n = 104), matched for pB-BMI, age, and parity; and group B (n = 104), matched for pP-BMI, age, and parity. RESULTS: In women exposed to BS, mean age was 27.1 (±4.9) years and pB-BMI was 46.0 (±4.6) kg/m2. Operated women differed significantly from group A but not from group B for pP-BMI (29.4 ± 6.1 versus 45.3 ± 4.5 group A versus 28.6 ± 6.6 group B) and gestational diabetes (12.0% versus 44.0% group A versus 17.0% group B), respectively. In the group of women exposed to BS, birth weight (g) was significantly lower (2960 ± 545 versus 3381 ± 735 group A versus 3310 ± 645 group B) and large-for-gestational-age infants less frequent (0% versus 13% group A versus 8% group B). CONCLUSION: Bariatric surgery reduced risks of excessive fetal growth and gestational diabetes with a trend for a higher risk of small-for-gestational-age, despite matching on pP-BMI suggesting a risk associated to BS and solely to previous surgery-induced weight loss.


Assuntos
Cirurgia Bariátrica , Complicações na Gravidez , Adulto , Índice de Massa Corporal , Estudos de Coortes , Feminino , Humanos , Recém-Nascido , Recém-Nascido Pequeno para a Idade Gestacional , Gravidez , Complicações na Gravidez/epidemiologia , Resultado da Gravidez , Estudos Retrospectivos
14.
Trials ; 21(1): 448, 2020 Jun 02.
Artigo em Inglês | MEDLINE | ID: mdl-32487210

RESUMO

BACKGROUND: Postoperative upper gastrointestinal fistula (PUGIF) is a devastating complication, leading to high mortality (reaching up to 80%), increased length of hospital stay, reduced health-related quality of life and increased health costs. Nutritional support is a key component of therapy in such cases, which is related to the high prevalence of malnutrition. In the prophylactic setting, enteral nutrition (EN) is associated with a shorter hospital stay, a lower incidence of severe infectious complications, lower severity of complications and decreased cost compared to total parenteral nutrition (TPN) following major upper gastrointestinal (GI) surgery. There is little evidence available for the curative setting after fistula occurrence. We hypothesize that EN increases the 30-day fistula closure rate in PUGIF, allowing better health-related quality of life without increasing the morbidity or mortality. METHODS/DESIGN: The NUTRILEAK trial is a multicenter, randomized, parallel-group, open-label phase III trial to assess the efficacy of EN (the experimental group) compared with TPN (the control group) in patients with PUGIF. The primary objective of the study is to compare EN versus TPN in the treatment of PUGIF (after esophagogastric resection including bariatric surgery, duodenojejunal resection or pancreatic resection with digestive tract violation) in terms of the 30-day fistula closure rate. Secondary objectives are to evaluate the 6-month postrandomization fistula closure rate, time of first fistula closure (in days), the medical- and surgical treatment-related complication rate at 6 months after randomization, the fistula-related complication rate at 6 months after randomization, the type and severity of early (30 days after randomization) and late fistula-related complications (over 30 days after randomization), 30-day and 6-month postrandomization mortality rate, nutritional status at day 30, day 60, day 90 and day 180 postrandomization, the mean length of hospital stay, the patient's health-related quality of life (by self-assessment questionnaire), oral feeding time and direct costs of treatment. A total of 321 patients will be enrolled. DISCUSSION: The two nutritional supports are already used in daily practice, but most surgeons are reluctant to use the enteral route in case of PUGIF. This study will be the first randomized trial testing the role of EN versus TPN in PUGIF. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03742752. Registered on 14 November 2018.


Assuntos
Nutrição Enteral/normas , Fístula Intestinal/terapia , Nutrição Parenteral Total/normas , Cuidados Pós-Operatórios/métodos , Complicações Pós-Operatórias/terapia , Ensaios Clínicos Fase III como Assunto , Tratamento Conservador , Ingestão de Energia , Nutrição Enteral/métodos , Humanos , Fístula Intestinal/etiologia , Fístula Intestinal/mortalidade , Tempo de Internação/estatística & dados numéricos , Estudos Multicêntricos como Assunto , Avaliação Nutricional , Nutrição Parenteral Total/métodos , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/mortalidade , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Procedimentos Cirúrgicos Operatórios/efeitos adversos , Fatores de Tempo
17.
Lancet Diabetes Endocrinol ; 7(10): 786-795, 2019 10.
Artigo em Inglês | MEDLINE | ID: mdl-31383618

RESUMO

BACKGROUND: Concerns are rising about the late adverse events following gastric bypass and sleeve gastrectomy. We aimed to assess, over a 7-year period, the late adverse events after gastric bypass and sleeve gastrectomy compared with matched control groups. METHODS: In this nationwide, observational, population-based, cohort study, we used data extracted from the French National Health Insurance (Système National des Données de Santé) database. All patients undergoing gastric bypass or sleeve gastrectomy in France in 2009, except those who had undergone bariatric surgery in the previous 4 years before inclusion, were matched with control patients with obesity in terms of age, sex, BMI category, baseline antidiabetic therapy, and baseline insulin therapy. Exclusion criteria for the control group included cancer, pregnancy, chronic infectious disease, serious acute or chronic disease in 2008-09, or previous (2005-09) or forthcoming (2010-11) bariatric surgery. The incidence rate was calculated for each type of adverse event leading to inpatient hospital admission over a 7-year period; incidence rate ratios (with 95% CIs) were computed to compare the rate of complications among the bariatric surgery and control groups. Risks of complications during follow-up were compared using Cox proportional-hazards regression analyses. Data were analysed according to the intention-to-treat methodology. FINDINGS: From Jan 1, 2009, to Dec 31, 2009, 8966 patients who underwent bariatric surgery (7359 [82%] women; mean age 40·4 years [SD 11·3]) and 8966 matched controls (7359 [82%] women; mean age 40·9 years [11·4]) were included in analyses 4955 (55%) off 8966 patients in the bariatric surgery group had a primary gastric bypass and 4011 (45%) patients had sleeve gastrectomy. With a mean follow-up of 6·8 years (SD 0·2), mortality was lower in the gastric bypass group than in its control group (hazard ratio 0·64 [95% CI 0·52-0·78]; p<0·0001) and in the sleeve gastrectomy group than in its control group (0·38 [0·29-0·50]; p<0·0001). The gastric bypass and sleeve gastrectomy groups had higher risk than did their control groups for invasive gastrointestinal surgery or endoscopy (incidence rate ratio 2·4 [95% CI 2·1-2·7], p<0·0001, for gastric bypass vs control and 1·5 [1·3-1·7], p<0·0001, for sleeve gastrectomy vs control); for gastrointestinal disorders not leading to invasive procedures (1·9 [1·7-2·1]), p<0·0001, for gastric bypass vs control and 1·2 [1·1-1·4], p<0·0001, for sleeve gastrectomy vs control); and for nutritional disorders (4·9 [3·8-6·4], p<0·0001, for gastric bypass vs control and 1·8 [1·3-2·5], p<0·0001, for sleeve gastrectomy vs control). For psychiatric disorders, there was no significant association (1·1 [0·9-1·4], p=0·190, for gastric bypass vs control and 1·1 [0·8-1·3], p=0·645, for sleeve gastrectomy vs control), except for gastric bypass and alcohol dependence (1·8 [1·1-2·8], p=0·0124). INTERPRETATION: Despite lower 7-year mortality, patients undergoing gastric bypass or sleeve gastrectomy had higher risk of hospital admission at least once for late adverse events, except for psychiatric disorders, than did control patients, with a higher risk observed after gastric bypass than with sleeve gastrectomy. FUNDING: None.


Assuntos
Gastrectomia/efeitos adversos , Derivação Gástrica/efeitos adversos , Gastroenteropatias/epidemiologia , Transtornos Mentais/epidemiologia , Distúrbios Nutricionais/epidemiologia , Obesidade Mórbida/cirurgia , Complicações Pós-Operatórias/epidemiologia , Adulto , Estudos de Coortes , Feminino , França/epidemiologia , Gastroenteropatias/etiologia , Humanos , Masculino , Transtornos Mentais/etiologia , Pessoa de Meia-Idade , Distúrbios Nutricionais/etiologia , Obesidade Mórbida/epidemiologia , Complicações Pós-Operatórias/fisiopatologia , Complicações Pós-Operatórias/terapia , Literatura de Revisão como Assunto , Fatores de Tempo , Resultado do Tratamento
18.
Eur J Surg Oncol ; 45(12): 2473-2481, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31350076

RESUMO

INTRODUCTION: Type II AEG is now considered as oesophageal cancer in the seventh and eighth edition of TNM classification but optimal surgical approach for these tumors remains debated. The objective of the study is to assess and compare surgical and oncological outcomes of two surgical approaches: superior polar oesogastrectomy (SPO) or total gastrectomy (TG) in patients with type II adenocarcinoma of the oesophagogastric junction (AEG). MATERIAL AND METHODS: 183 patients with type II AEG treated from 1997 to 2010 in 21 French centers by SPO or TG were included in a multicenter retrospective study. The surgical and oncological outcomes were compared between these two surgical approaches. RESULTS: A TG was performed in 64 (35%) patients whereas 119 (65%) patients were treated by SPO with transthoracic approach in 100 of them (83.2%) and transhiatal approach with cervicotomy in 19 (16.8%). Surgical outcomes were comparable between the two approaches with a postoperative mortality rate of 4.9% and a severe operative morbidity rate within 30 days of 15.3%. Median survival in patients operated on by TG was of 46 months compared to 27 months in patients treated by SPO (p = 0.118). At multivariate analysis, TG appears to be an independent good prognostic factor compared to SPO (HR = 1.847; p = 0.008). However, TG was also associated with a higher rate of incomplete resection, (12.5% vs 5.9%; p = 0.120). CONCLUSION: When TG allows obtaining tumor-free resection margins, this approach should be preferred to SPO.


Assuntos
Adenocarcinoma/cirurgia , Cárdia/cirurgia , Neoplasias Esofágicas/cirurgia , Junção Esofagogástrica/cirurgia , Gastrectomia/métodos , Adenocarcinoma/mortalidade , Adenocarcinoma/patologia , Cárdia/patologia , Neoplasias Esofágicas/mortalidade , Neoplasias Esofágicas/patologia , Junção Esofagogástrica/patologia , Feminino , França , Humanos , Masculino , Pessoa de Meia-Idade , Terapia Neoadjuvante , Estadiamento de Neoplasias , Estudos Retrospectivos , Taxa de Sobrevida
19.
Int J Surg ; 53: 257-261, 2018 May.
Artigo em Inglês | MEDLINE | ID: mdl-29621656

RESUMO

PURPOSE: Surgery remains the mainstay of gastrointestinal stromal tumors (GISTs) treatment. The aim of our study was to compare postoperative outcomes and long term oncologic results of GISTs resection. An analysis of laparoscopic versus open surgery for GISTs and a subgroup analysis of lesions larger than 5 cm were realized. MATERIALS AND METHODS: Between January 2005 and December 2014, 143 patients with primary GISTs were treated with radical resection in two tertiary centers. Eight patients with metastatic disease were excluded. The remaining patients were assigned to 2 groups: laparoscopy and open surgery. A separate analysis of tumors larger than 5 cm was realized for the laparoscopy group. Long-term follow-up was used to analyze the oncologic and surgical results. Relevant clinical variables were evaluated using univariate and multivariate analyses. RESULTS: With similar oncological outcomes(p = 0.09) and morbidity(p = 0.56), laparoscopy compared to open surgery significantly reduced length of hospitalization (p = 0.01). For lesions >5 cm laparoscopic resection is associated with similar short-term outcomes with resection for small tumors without compromising oncological outcomes (p = 0.89). For all patients, the probability of remaining disease free at 3 years, and 5 years was 97, 6% and 95%, respectively. CONCLUSION: Laparoscopic resection is a technically and oncologically safe and feasible approach for GISTs compared with open resection. Resection of lesions superior of 5 cm by laparoscopy has efficacy and recurrence rates similar to open surgical controls. Large tumor resection should only be attempted by surgeons with a large experience with minimally invasive surgery in order to avoid operative complications and unfavorable long term outcome.


Assuntos
Gastrectomia/métodos , Tumores do Estroma Gastrointestinal/cirurgia , Laparoscopia , Neoplasias Gástricas/cirurgia , Adulto , Idoso , Intervalo Livre de Doença , Feminino , Hospitalização , Humanos , Laparoscopia/métodos , Tempo de Internação/estatística & dados numéricos , Masculino , Pessoa de Meia-Idade , Recidiva Local de Neoplasia/cirurgia , Segunda Neoplasia Primária/cirurgia , Estudos Retrospectivos
20.
Thromb Res ; 164: 79-84, 2018 04.
Artigo em Inglês | MEDLINE | ID: mdl-29522910

RESUMO

BACKGROUND: Venous thromboembolism (VTE) can be the first manifestation of cancer; however, the current incidence of malignancy in unselected patients with first unprovoked VTE needs to be confirmed. MATERIAL AND METHODS: Between March 1st, 2013 and February 28th, 2015 we included and followed-up all patients living in the Brest district, France, who were seen in hospitals or the community for a first symptomatic unprovoked VTE event. The primary study outcome was the one-year incidence of cancer. RESULTS: 526 patients, mean age 66.6 ±â€¯18.1 years, 246 (46.8%) men, were included in the study. In the year following VTE, 26 patients were diagnosed with cancer, corresponding to a one-year cumulative incidence of cancer of 5.06% (95% CI 3.47-7.35). Age ≥60, smoking and pulmonary embolism were significantly associated with cancer diagnosis in multivariate analysis. Fifty percent of cancers were patent at the time of VTE diagnosis, mostly detected on CTPA (Computed Tomographic Pulmonary Angiography) performed for pulmonary embolism assessment. After excluding patients with patent cancer at VTE diagnosis, the one-year incidence of cancer was 2.65% (95% CI: 1.55-4.52); in multivariate analysis, only current smoking was independently associated with a significant 5.4-fold increased risk for cancer diagnosis (HR 5.40; 95% CI 1.31-22.27). No cancer was diagnosed in patients aged 50 years or younger. CONCLUSION: The one-year incidence of cancer after a first unprovoked VTE was 5.06%. Half of the cancers were diagnosed during the diagnosis procedure for pulmonary embolism using CTPA.


Assuntos
Detecção Precoce de Câncer/métodos , Neoplasias/etiologia , Trombose Venosa/complicações , Idoso , Feminino , Humanos , Incidência , Masculino , Neoplasias/patologia , Fatores de Risco
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