INTRODUCTION: Heart surgery is associated with a sternotomy in most patients. Low serum calcidiol level below 80 nmol/l carries the risk of bone loss as a risk factor in sternotomy healing. OBJECTIVES: The primary objective was to compare postoperative complications of sternotomy healing in two groups of patients treated with cholecalciferol or placebo. Secondary objectives were focused on the degree of sternal healing, length of hospitalization, number of days spent in ICU and mechanical ventilation, and number of repeated hospitalizations for sternotomy complications. METHODOLOGY: Monocentric, randomized, double-blind, placebo-controlled, prospective study was conducted from September 2016 to December 2020 at Na Homolce Hospital. Of the 216 originally recruited and randomized subjects, 141 completed the study. Seventy-two subjects were enrolled in the cholecalciferol arm, and sixty-nine subjects in the placebo arm. The detailed methodology has been published previously. The results are presented as a comparison between two groups: calcidiol above 80 nmol/l (saturated subjects) and the calcidiol lower or equal to 80 nmol/l (unsaturated subjects). RESULTS: Statistics include 141 subjects. After a 6-month follow-up, CT imaging and calcidiol levels were performed. PRIMARY OBJECTIVE: postoperative complications in sternotomy were not among the population under or above 80 nmol/l statistical difference (p = 0.907). SECONDARY OBJECTIVES: monitored parameters did not differ between individual arms. But the key was the state of saturation with calcidiol (> 80 nmol/l), which was associated with a significantly lower risk of complete non-healed sternotomy (p = 0.008). CONCLUSION: Optimal calcidiol level (> 80 nmol/l) indicates a positive trend towards greater sternal healing. Cholecalciferol oral administration can be considered as a safe method how to achieve the required calcidiol concentration. TRIAL REGISTRATION: EU Clinical Trials Register, EUDRA CT No: 2016-002606-39.
- MeSH
- časové faktory MeSH
- cholekalciferol * aplikace a dávkování MeSH
- dvojitá slepá metoda MeSH
- hojení ran * účinky léků MeSH
- kalcifediol * krev MeSH
- kardiochirurgické výkony * škodlivé účinky MeSH
- lidé středního věku MeSH
- lidé MeSH
- pooperační komplikace etiologie MeSH
- prospektivní studie MeSH
- senioři MeSH
- sternotomie * škodlivé účinky MeSH
- sternum * diagnostické zobrazování chirurgie MeSH
- výsledek terapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- randomizované kontrolované studie MeSH
- MeSH
- chybná diagnóza MeSH
- lidé středního věku MeSH
- lidé MeSH
- metastázy nádorů MeSH
- nádory štítné žlázy * diagnóza terapie MeSH
- výsledek terapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- Publikační typ
- kazuistiky MeSH
BACKGROUND: Neuroendocrine neoplasms (NENs) are rare tumours with variable clinical behaviour. Their natural history is ideally best approached in large, multicentre and multinational registries with long-term patients' follow-up. The European Neuroendocrine Tumour Society registry aims to obtain information regarding NEN outcomes and prognostic factors in a European frame. PATIENTS AND METHODS: We collected data from 7 national NEN registries (Belgium, Czech Republic, Germany, Greece, Poland, Spain, Switzerland), representing 10,102 patients. Anonymised/pseudonymised data were collected in a secured server. Descriptive statistical methods were applied, as well as Kaplan-Meier survival curves and multivariable analyses for prognostic factors of overall survival (OS). RESULTS: median age of the study population was 60 years (range: 18-102), 48% were female. Common primary tumour sites were pancreas (27%) and small intestine (21%). Stage 4 disease was found in 47% of patients, while 26/10/16% had stage 1/2/3 disease, respectively. Grading (n = 6952) was G1/2/3 in 48/37/15% of the patients, respectively. Surgery was the main treatment, provided to 71% of patients, followed by somatostatin analogues (32%), chemotherapy (20%), Peptide receptor Radionuclide Therapy (PRRT) (9%) and targeted therapies (8%). OS at 5 years was 74%, influenced by grade, stage and tissue of origin in multivariate analysis. A Ki67 cut-off value set at 55% within the G3 group allowed to separate 2 groups with a meaningful different OS. CONCLUSION: We report the first analysis of the European Neuroendocrine Tumour Society registry, comprising 10,102 patients with NEN from 7 European countries. This large cohort study describes prognostic factors for the survival of NENs throughout Europe, including primary tumour site, grade, stage and treatment.
- MeSH
- dospělí MeSH
- kohortové studie MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladiství MeSH
- mladý dospělý MeSH
- nádory slinivky břišní * patologie MeSH
- neuroendokrinní nádory * patologie MeSH
- prognóza MeSH
- registrace * MeSH
- retrospektivní studie MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- somatostatin MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladiství MeSH
- mladý dospělý MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- Klíčová slova
- peptide receptor radionuclide therapy,
- MeSH
- dospělí MeSH
- lidé MeSH
- lokální recidiva nádoru chirurgie diagnóza patologie MeSH
- metastázy nádorů diagnóza terapie MeSH
- nádory slinivky břišní MeSH
- neuroendokrinní nádory * diagnóza komplikace terapie MeSH
- progrese nemoci MeSH
- radionuklidy terapeutické užití MeSH
- radioterapie metody MeSH
- transplantace jater škodlivé účinky MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé MeSH
- ženské pohlaví MeSH
- Publikační typ
- kazuistiky MeSH
