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Farges O.,University Paris Diderot | Regimbeau J.M.,Center Hospitalier University dAmiens | Fuks D.,Center Hospitalier University dAmiens | Le Treut Y.P.,Hopital Conception | And 3 more authors.
British Journal of Surgery | Year: 2013

Background: Indications for preoperative biliary drainage (PBD) in the context of hepatectomy for hilar malignancies are still debated. The aim of this study was to investigate current European practice regarding biliary drainage before hepatectomy for Klatskin tumours. Methods: This was a retrospective analysis of all patients who underwent formal or extended right or left hepatectomy for hilar cholangiocarcinoma between 1997 and 2008 at 11 European teaching hospitals, and for whom details of serum bilirubin levels at admission and at the time of surgery were available. PBD was performed at the physicians' discretion. The primary outcome was 90-day mortality. Secondary outcomes were morbidity and cause of death. The association of PBD and of preoperative serum bilirubin levels with postoperative mortality was assessed by logistic regression, in the entire population as well as separately in the right- and left-sided hepatectomy groups, and was adjusted for confounding factors. Results: A total of 366 patients were enrolled; PBD was performed in 180 patients. The overall mortality rate was 10·7 per cent and was higher after right- than left-sided hepatectomy (14·7 versus 6·6 per cent; adjusted odds ratio (OR) 3·16, 95 per cent confidence interval 1·50 to 6·65; P = 0·001). PBD did not affect overall postoperative mortality, but was associated with a decreased mortality rate after right hepatectomy (adjusted OR 0·29, 0·11 to 0·77; P = 0·013) and an increased mortality rate after left hepatectomy (adjusted OR 4·06, 1·01 to 16·30; P = 0·035). A preoperative serum bilirubin level greater than 50 μmol/l was also associated with increased mortality, but only after right hepatectomy (adjusted OR 7·02, 1·73 to 28·52; P = 0·002). Conclusion: PBD does not affect overall mortality in jaundiced patients with hilar cholangiocarcinoma, but there may be a difference between patients undergoing right-sided versus left-sided hepatectomy. Copyright © 2012 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.


Lioure B.,Hopital Hautepierre | Fornecker L.,Hopital Hautepierre | Wendling M.-J.,Hopitaux Universitaires Of Strasbourg | Stoll-Keller F.,Hopitaux Universitaires Of Strasbourg | Bigaillon C.,Hopital Begin
Journal of Clinical Virology | Year: 2012

Background: Human HEV infections reported in Europe without previous travel to endemic regions are linked to exposure to genotype 3 Hepatitis E virus (HEV).Genotype 3 is widely distributed through human cases and zoonotic reservoir. The geographical distribution of genotype 4 is limited to Asian countries. Objectives: The first human case of autochthonous genotype 4 hepatitis E infectionwasreported in France. Study design: The HEV infection was described in an immunosuppressed patient, presenting an acute myeloblastic leukemia. Investigation of the case was performed on detection of HEV markers in the patient and in the environment. Results: Hepatitis E infection was diagnosed on the basis of HEV RNA viremia, and detection of anti-HEV IgM. The prognostic of leukemia was favorable and HEV was cleared without relapsing. HEV isolate was classified into genotype 4. Conclusions: The recent characterization of genotype 4 HEV through swine surveillance in Europe and the description of the first human case in France open interesting questions about the circulation of this genotype: health risks in human population, transmission patterns, and zoonotic reservoir. © 2012 Elsevier B.V.


Boulvain M.,University of Geneva | Senat M.-V.,University Paris - Sud | Perrotin F.,Pole de Gynecologie Obstetrique | Winer N.,Departement de Gynecologie Obstetrique | And 16 more authors.
The Lancet | Year: 2015

Background Macrosomic fetuses are at increased risk of shoulder dystocia. We aimed to compare induction of labour with expectant management for large-for-date fetuses for prevention of shoulder dystocia and other neonatal and maternal morbidity associated with macrosomia. Methods We did this pragmatic, randomised controlled trial between Oct 1, 2002, and Jan 1, 2009, in 19 tertiary-care centres in France, Switzerland, and Belgium. Women with singleton fetuses whose estimated weight exceeded the 95th percentile, were randomly assigned (1:1), via computer-generated permuted-block randomisation (block size of four to eight) to receive induction of labour within 3 days between 37+0 weeks and 38+6 weeks of gestation, or expectant management. Randomisation was stratified by centre. Participants and caregivers were not masked to group assignment. Our primary outcome was a composite of clinically significant shoulder dystocia, fracture of the clavicle, brachial plexus injury, intracranial haemorrhage, or death. We did analyses by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00190320. Findings We randomly assigned 409 women to the induction group and 413 women to the expectant management group, of whom 407 women and 411 women, respectively, were included in the final analysis. Mean birthweight was 3831 g (SD 324) in the induction group and 4118 g (392) in the expectant group. Induction of labour significantly reduced the risk of shoulder dystocia or associated morbidity (n=8) compared with expectant management (n=25; relative risk [RR] 0·32, 95% CI 0·15-0·71; p=0·004). We recorded no brachial plexus injuries, intracranial haemorrhages, or perinatal deaths. The likelihood of spontaneous vaginal delivery was higher in women in the induction group than in those in the expectant management group (RR 1·14, 95% CI 1·01-1·29). Caesarean delivery and neonatal morbidity did not differ significantly between the groups. Interpretation Induction of labour for suspected large-for-date fetuses is associated with a reduced risk of shoulder dystocia and associated morbidity compared with expectant management. Induction of labour does not increase the risk of caesarean delivery and improves the likelihood of spontaneous vaginal delivery. These benefits should be balanced with the effects of early-term induction of labour. Funding Assistance Publique-Hôpitaux de Paris and the University of Geneva. © 2015 Elsevier Ltd.


Arnould L.,Center Georges Francois Leclerc | Roger P.,Nimes University Hospital Center | MacGrogan G.,Institute Bergonie | Chenard M.-P.,Hopital Hautepierre | And 3 more authors.
Modern Pathology | Year: 2012

Preoperative breast cancer diagnosis on core biopsies has become a standard of care in many countries. Controversies exist concerning the accuracy of HER2 testing on biopsies as compared with surgical specimens, and few data exist concerning the use of emerging technologies such as bright-field in-situ hybridization in such a setting. A French multicenter, cross-sectional, histopathological study assessed the concordance of HER2 status determined by immunohistochemistry and silver (SISH) or chromogenic in-situ hybridization (CISH) on core-needle biopsies with HER2 status determined by fluorescence in-situ hybridization (FISH) on surgical specimens. The concordance between biopsy and operative results was also assessed for each method. We studied 260 breast tumors from 24 centers between April 2003 and August 2009. Excellent concordance (: 0.92-0.97) was shown between immunohistochemistry and FISH with low discordance rates (2-4%), high specificity (97-98%) and sensitivity values (95-99%), with no significant difference according to the immunohistochemistry interpretation guidelines used. The correlation between SISH and CISH on biopsies and FISH on surgical samples was strong (κ:>0.96 and 0.94, respectively), with no significant difference between false negative rates or sensitivity and specificity values (2 and 5%, 99 and 96%, 98 and 98%, respectively). Whatever the evaluation technique, excellent concordance between biopsies and surgical specimens was observed ( 0.97; discordance rates between 1 and 2%), with high sensitivity (98-99%) and specificity (98-100%). Based on these results, when FISH cannot be used, SISH and/or CISH could be proposed as an alternative method to determine HER2 status and to confirm any ambiguous immunohistochemistry results, either for preoperative percutaneous biopsies or for surgical specimens. They could also be used for quality controls and immunohistochemistry calibration. © 2012 USCAP, Inc. All rights reserved.


Soubrier M.,Hopital G Montpied | Lukas C.,Hopital Lapeyronie | Sibilia J.,Hopital Hautepierre | Fautrel B.,Hopital la Pitie Salpetriere | And 4 more authors.
Annals of the Rheumatic Diseases | Year: 2011

Objectives: To compare the efficacy of disease activity score in 28 joints (DAS28ESR)-driven therapy with antitumour necrosis factor (patients from the GUEPARD trial) and routine care in patients with recent-onset rheumatoid arthritis (patients of the ESPOIR cohort). Results: After matching GUEPARD and ESPOIR patients on the basis of a propensity score and a 1:2 ratio, at baseline all patients had comparable demographic characteristics, rheumatoid factor, anticyclic citrullinated peptide antibody positivity and clinical disease activity parameters: erythrocyte sedimentation rate, C-reactive protein, mean DAS (6.26±0.87), Sharp/van der Heijde radiographic score (SHS), health assessment questionnaire (HAQ). Disease duration was longer in GUEPARD patients (5.6±4.6 vs 3.5±2.0 months, p<0.001). After 1 year, the percentage of patients in remission with an HAQ (<0.5) and an absence of radiological progression was higher in the tight control group (32.3% vs 10.2%, p=0.011) as well as the percentage of patients in low DAS with an HAQ (<0.5) and an absence of radiological progression (36.1% vs 18.9%, p=0.045). However, there was no difference in the decrease in DAS, nor in the percentage of EULAR (good and moderate), ACR20, ACR50 and ACR70 responses. More patients in the tight control group had an HAQ below 0.5 (70.2% vs 45.2%, p=0.005). Overall, pain, patient and physician assessment and fatigue decreased more in the tight control group. The mean SHS progression was similar in the two groups as was the percentage of patients without progression. Conclusions: In patients with recent onset active rheumatoid arthritis, a tight control of disease activity allows more patients to achieve remission without disability and radiographic progression.


Leveque D.,Hopital Hautepierre
Bulletin du Cancer | Year: 2016

Biosimilar drugs are biologic drugs clinically similar to the reference products. They correspond to a generic approach applied to biologic agents. Biosimilars are aimed to provide cheaper drugs by enhancing the concurrency. The approval of biosimilars is abbreviated when compared to that of the reference biologics but includes clinical trials (distinguishing them from the generics). Current available biosimilars in oncology are filgrastim and epoietin alpha. In the next future, will be launched rituximab and trastuzumab. In France, the development of biosimilars is faced with many hurdles that necessitates a better information of physicians and a greater price discount in the out-patient setting. More globally, harmonisation of recommendations particularly concerning extrapolation of indications and nomenclature are needed for a better acceptance. © 2016 Société Française du Cancer.


De Seze J.,Hopital Hautepierre
Revue Neurologique | Year: 2012

Inflammatory optic neuritis (ON) represents a frequent clinical situation in neurology and ophthalmology. The most current etiology is multiple sclerosis (MS) but, when MRI and Cerebrospinal fluid (CSF) analyses are normal, ON is usually considered as "idiopathic" with a suspected viral etiology. In rare cases, a systemic disease such as sarcoidosis, lupus or Sjögren syndrome may be diagnosed. In several cases either a recurrence or a myelitis may occur without any argument for MS. In the first case, it corresponds to relapsing inflammatory optic neuritis (RION) and in the second case to neuromyelitis optica (NMO). In the present paper, the author successively presents the various clinical situations and complementary findings (infectious, vasculitis, NMO or idiopathic) that can lead to a differential diagnosis of MS in a context of ON. © 2012 Elsevier Masson SAS.


Moor B.K.,Hopital du Valais | Ehlinger M.,Hopital Hautepierre | Arlettaz Y.,Hopital du Valais
Orthopaedics and Traumatology: Surgery and Research | Year: 2012

Background: During the last decades, intramedullary nailing has become the standard treatment for diaphyseal fractures of long bones. Numerous innovative techniques and devices have been proposed to simplify distal locking. Each has its own limitations and, as a result, the fluoroscopy-dependent " free-hand technique" remains the most popular method. However, radiation exposure to the patient and operating room staff remains a concern. Methods: Before the development of a new radiation-independent, nail-mounted targeting system, we mathematically analyzed the aiming accuracy that such a system has to achieve. The correctness of this mathematical model was evaluated using a mechanical testing apparatus. Findings: We found a quite large targeting range for the unimpeded passage of the drill bit through the locking hole of a given nail. Important degrees of nail bending can thereby be compensated. As predicted by the mathematical formula, a 4-mm drill bit passed the distal locking hole of a 320/11. mm femoral nail up to a deflection of ±13. mm in the coronal plane. Interpretation: This mathematical model can be considered to be an additional tool for the development of new targeting devices. Combining our mathematical model with data previously published, not only torsional deformation along the longitudinal axis of the nail but also bending in the coronal plane can approximately be neglected. Hence, the three-dimensional aiming process can be simplified to the determination of the interlocking hole of the nail in the sagittal plane provided that the insertion-induced nail deformation in vivo stays in the range of that observed in vitro. Level of evidence: Level III. Basic sciences control study. © 2011 Elsevier Masson SAS.


De Seze J.,Hopital Hautepierre
Neuro-Ophthalmology | Year: 2013

Inflammatory optic neuritis represents a frequent clinical situation in neurology and ophthalmology. In those parts of the world where multiple sclerosis is common, it is the condition most discussed as the cause of optic neuritis. However, the risk for conversion from optic neuritis to multiple sclerosis is evaluated at only around 50% after 15 years of follow-up. The risk is higher in cases in whom abnormalities typical of multiple sclerosis are found on magnetic resonance imaging of the brain and oligoclonal bands found on cerebrospinal fluid protein electrophoresis with no corresponding bands in serum. When these investigations are normal, optic neuritis is usually considered as "idiopathic" with a suspected viral aetiology, but in some cases, a systemic disease such as sarcoidosis, systemic lupus erythematosis, or Sjögren syndrome may be diagnosed. In rare cases, either recurrent optic neuritis or myelitis may occur without any evidence for multiple sclerosis. In the first case, it corresponds to a recently characterised disorder referred to as chronic relapsing inflammatory optic neuropathy and in the second case to a recently better identified entity, neuromyelitis optica. In the present paper, the differential diagnosis of inflammatory optic neuritis is presented from multiple sclerosis to infectious optic neuritis, systemic disease, and neuromyelitis optica. © 2013 Informa Healthcare USA, Inc. All rights reserved: reproduction in whole or part not permitted.


Leveque D.,Hopital Hautepierre
World Journal of Clinical Oncology | Year: 2016

Off-label use is defined by the prescription of a marketed drug outside the conditions described in the summary of product characteristics. In oncology, off-label prescribing of targeted therapies may occur in patients with other tumor types expressing the same target. Agents associated to phenotypic approaches such as therapies against the tumoral vasculature (anti-angiogenic drugs) and new immunotherapies (checkpoint inhibitors) also carry the potential of alternative indications or combinations. Off-label use of targeted therapies is little documented and appears to be in the same range than that regarding older drugs with wide variations among agents. When compared with older agents, off-label use of targeted therapies is probably more rational through tumoral genotyping but is faced with a limited clinical support, reimbursement challenges related to the very high pricing and the cost of genotyping or molecular profiling, when applicable. ©2016 Baishideng Publishing Group Inc. All rights reserved.

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