Marseille, France
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Calmus Y.,Hopital Cochin | Duvoux C.,Hopital Henri Mondor | Pageaux G.,Hopital Saint Eloi | Wolf P.,Hopital Hautepierre | And 12 more authors.
Journal of Hepatology | Year: 2012

Background & Aims: We aimed at determining the effect of maintenance therapy with ribavirin alone, after a year of combined peginterferon-alfa 2a (PegIFNα-2a) and ribavirin therapy, on viral response and liver histology after liver transplantation (LT). Methods: Hundred and one patients with recurrent HCV and a minimum of stage 1 fibrosis (METAVIR scoring), 1-5 years after LT, were enrolled. PegIFNα-2a and ribavirin were initiated at 90 μg/wk and 600 mg/d, respectively, then increased or adjusted as a function of tolerance. At 12 months, combination therapy was discontinued and patients were randomized to ribavirin or placebo for a further 12 months. Growth factor use was permitted. Results: At 18 months, a sustained virological response (SVR) was obtained in 47.9% of patients in Per Protocol (PP) analysis, and was higher in patients with genotype 2 or 3 than in patients with genotype 1 or 4, in patients with genotypes 1 + 4 receiving ciclosporine than in those receiving tacrolimus, in patients with worse renal function, in those having received EPO, in patients with lower weight, and in those with lower viral load at 3 months. Using logistic regression, only the early viral response, recipient weight and renal function were independently associated with better SVR. SVR, viral load, activity, and fibrosis scores were similar, at M18 and M30, in patients randomized to ribavirin, or to placebo. Conclusions: A PP SVR was achieved in 47.9% of patients with established recurrent hepatitis C after LT. Maintenance therapy with ribavirin alone does not improve the virological response or the histological parameters. © 2012 European Association for the Study of the Liver.


PubMed | University of Poitiers, CHI Poissy St Germain, Center Hospitalier Of Versailles, University of Versailles and 11 more.
Type: | Journal: Trials | Year: 2015

Incomplete spontaneous abortions are defined by the intrauterine retention of the products of conception after their incomplete or partial expulsion. This condition may be managed by expectant care, medical treatment or surgery. Vacuum aspiration is currently the standard surgical treatment in most centers. However, operative hysteroscopy has the advantage over vacuum aspiration of allowing the direct visualization of the retained conception product, facilitating its elective removal while limiting surgical complications. Inadequately powered retrospective studies reported subsequent fertility to be higher in patients treated by operative hysteroscopy than in those treated by vacuum aspiration. These data require confirmation in a randomized controlled trial comparing fertility rates between women undergoing hysteroscopy and those undergoing vacuum aspiration for incomplete spontaneous abortion.After providing written informed consent, 572 women with incomplete spontaneous abortion recruited from 15 centers across France will undergo randomization by a centralized computer system for treatment by either vacuum aspiration or operative hysteroscopy. Patients will not be informed of the type of treatment that they receive and will be cared for during their hospital stay in accordance with standard practices at each center. The patients will be monitored for pregnancy or adverse effects by a telephone conversation or questionnaire sent by e-mail or post over a period of two years. In cases of complications, failure of the intervention or diagnosis of uterine cavity disease, patient care will be left to the discretion of the medical center team.If our hypothesis is confirmed, this study will provide evidence that the use of operative hysteroscopy can increase the number of pregnancies continuing beyond 22weeks of gestation in the two-year period following incomplete spontaneous abortion without increasing the incidence of morbidity and peri- and postoperative complications. The standard surgical treatment of this condition would thus be modified. This study would therefore have a large effect on the surgical management of incomplete spontaneous abortion.ClinicalTrials.gov Identifier: NCT02201732 ; registered on 17 July 2014.


Halfon P.,Hopital Ambroise Pare | Halfon P.,Laboratoire Alphabio | Benmoura D.,Hopital Ambroise Pare | Agostini A.,Hopital la Conception | And 4 more authors.
Cancer Biomarkers | Year: 2010

Background: The detection of high-risk human papillomavirus (HPV) DNA provides higher sensitivity but lower specificity than cytology for the identification of high-grade cervical intraepithelial neoplasia (CIN). Objectives: The aim of this study was to combine DNA-and RNA-based assays in order to improve the detection of advanced disease (CIN2+). Methods: 107 ASCUS+ women were included in Marseilles (France) between March 2007 and June 2008. Up to five tests were carried out on a liquid PreservCyt sample: Hybrid Capture 2 (HCII) (Digene), Papillocheck (Greiner), Abbott RealTime HR HPV (RT HR HPV) (Abbott), Linear Array (Roche), and EasyQ HPV (Biomérieux). Results: 36 (34%) women had CIN2+ histology; among them 6 (6%) had CIN3+ histology. For CIN2+ detection, all tests had comparable sensitivities except EasyQ HPV test: HCII 94%, Papillocheck and LA 92%, RT HR HPV 89%, and NucliSENS EasyQ HPV 75% (P not significant). On the other hand, EasyQ HPV had a higher specificity than the other assays (except RT HR HPV assay). Combining DNA-based and RNA-based assay would allow to reduce the need of colposcopies to be performed among patients HPV positive with DNA-based assay: 32% (7/22) colposcopies not needed in < 30 years old patients, and 29% (14/49) colposcopies not needed in ≥ 30 years patients. Conclusions: All tests had comparable diagnostic values for CIN2+ detection, but DNA-based tests seemed to be more sensitive and RNA-based assay more specific. The combined use of DNA-and RNA-based assays considerably reduces the number of colposcopies to be performed, and provides better diagnostic accuracy for CIN2+ disease. © 2010-IOS Press and the authors. All rights reserved.


Soukup V.,Charles University | Babjuk M.,Charles University | Bellmunt J.,University of the Sea | Dalbagni G.,Sloan Kettering Cancer Center | And 5 more authors.
European Urology | Year: 2012

Context: Follow-up of patients treated for bladder cancer (BCa) is of great importance for both non-muscle-invasive BCa (NMIBC) and muscle-invasive BCa (MIBC) because of the high incidence of recurrence and progression. The schedule and methods of follow-up should reflect the individual clinical situation. Objective: To evaluate the existing evidence for intensity and duration of follow-up recommendations in patients after surgical treatment of BCa. Evidence acquisition: We searched the Medline, Embase, and Cochrane databases for published data on the follow-up of patients with NMIBC and MIBC after radical cystectomy (RC). Evidence synthesis: Follow-up in patients with NMIBC is necessary because of the high probability of tumour recurrence and the risk of progression. Cystoscopy plus cytology are the standard methods for follow-up. Cystoscopy should be done 3 mo after the transurethral resection in every patient, and the frequency after that depends on the individual recurrence/progression risk. Cytology should be used as an adjunctive method to cystoscopy in intermediate- and high-risk patients. None of the currently available urinary markers or imaging methods can substitute for cystoscopy-based follow-up. High-risk NMIBC patients require regular lifelong upper urinary tract monitoring. Follow-up in MIBC is based on the fact that early detection of recurrence after RC allows for timely treatment with the aim of improving outcomes. Patients with extravesical and lymph node-positive disease should have the most intensive follow-up because of the highest recurrence risk. Routine upper urinary tract imaging is advisable for all patients and should continue in the long term. Follow-up also allows for early detection of urinary diversion-related complications, the rate of which increases with time. Conclusions: Follow-up in BCa is necessary for diagnosing recurrence and progression, as well as for evaluating complications after radical treatment. Since randomised studies investigating the most appropriate follow-up schedule are lacking, most recommendations are based on only the retrospective experience. Nonetheless, reasonable recommendations can be made until further prospective randomised studies testing different follow-up schedules have been performed. © 2012 European Association of Urology.


Halfon P.,Hopital Ambroise Pare | Halfon P.,Laboratoire Alphabio | Benmoura D.,Hopital Ambroise Pare | Agostini A.,Hopital La Conception | And 4 more authors.
Journal of Clinical Virology | Year: 2010

Background: Abbott RealTime (RT) High-Risk (HR) HPV assay is a new qualitative real-time polymerase chain reaction (PCR) based assay for the detection of 14 HR HPV DNA. The assay can differentiate between the infection by HPV 16, HPV 18 and non-HPV 16/18 types through the distinct fluorescent labels on the type specific probes. Objectives: To evaluate the clinical performance of the Abbott RT HR HPV test, in comparison with biopsy, Hybrid Capture II (HCII), and Linear Array (LA), for detection of high-grade disease (CIN2+). Study design: The study population consisted of 143 women who were included in three referral gynecology clinics in Marseilles (France) between March 2007 and June 2008. The clinical performance of the RT HR HPV assay, performed on the fully automated m2000 system, was compared with HCII and LA. Results: HR HPV positivity rate was similar for all tests (Abbott RT HR HPV and HCII, 62%, and LA 63%). All tests had high sensitivities and negative predictive values for CIN2+ detection (>90%). The agreement between HCII and Abbott RT HR HPV, and between HCII and LA were 93% (k= 0.85) and 96% (k= 0.91) respectively. As expected, HPV16 or HPV18 positivity was greater in advanced grades of disease, especially in CIN2+ patients: 85% in CIN2+ vs. 33% in


Halfon P.,Laboratoire Alphabio | Benmoura D.,Hopital Ambroise Pare | Agostini A.,Hopital La Conception | Khiri H.,Laboratoire Alphabio | And 3 more authors.
Journal of Clinical Virology | Year: 2010

Background: DNA- and mRNA-based assays are the main tools used for detecting human papillomavirus (HPV) nucleic acid in clinical samples. A recent tool, NucliSENS EasyQ HPV, uses a new concept to directly detect the expression of HPV oncogenic factors (E6 and E7) from the most prevalent HPV genotypes in cervical cancer (16, 18, 31, 33 and 45). Objectives: The primary aim of the study is to assess the accuracy of NucliSENS EasyQ HPV in detecting high-risk (HR) HPV in a population of atypical cells of undetermined significance/low-grade squamous intraepithelial lesion/high-grade squamous lesion (ASCUS/LSIL/HSIL) patients using a clinical cut-off of a cervical dysplasia (CIN2+) histology. The secondary aim is to compare this mRNA-based assay with the DNA-based hybrid capture II (HCII) assay. Study design: The study population comprised 140 women referred for colposcopy and histology. NucliSENS EasyQ HPV test, hybrid capture II (HCII) test and linear array (LA) test were assessed on all samples. All the tests were performed on the samples collected in PreservCyt liquid media for liquid-based cytology (ThinPrep Pap test). Results: The clinical specificity of the NucliSENS EasyQ HPV was 63% for the detection of CIN2+ or HSIL patients, significantly higher than the specificity of HCII and LA (49% and 45%, respectively, p < 0.05). Agreement between HCII and NucliSENS EasyQ HPV was fair (k = 0.49) and was good between HCII and LA (k = 0.88). HPV 16 was the most-detected type (49% with NucliSENS EasyQ HPV and 56% with LA), and HPV 31 was the second most-detected HPV type (31% with NucliSENS EasyQ HPV and 29% with LA). Conclusions: The NucliSENS EasyQ HPV assay has interesting clinical sensitivity and specificity for the detection of HPV types in CIN2+ patients and shows comparable diagnostic values with the HCII DNA assay. This assay allows simultaneous detection of HPV mRNA and determination of the type of the main prevalent oncogenic virus. © 2009 Elsevier B.V. All rights reserved.


Devauchelle-Pensec V.,University of Western Brittany | Devauchelle-Pensec V.,European University of Brittany | D'Agostino M.A.,University of Versailles | Marion J.,Brest Teaching Hospitals | And 11 more authors.
Arthritis and Rheumatism | Year: 2012

Objective To assess the performance of computed tomography (CT) scanning for ascertaining sacroiliitis in patients with suspected spondylarthritis (SpA). Methods The Echography in Spondylarthritis French cohort consists of 489 patients with suspected SpA. At baseline, all patients underwent clinical examination, HLA-B typing, and pelvic radiography. Pelvic CT scanning was performed if sacroiliitis on radiography was considered uncertain or if patients presented with buttock pain duration of >6 months. A set of 100 paired radiographs and CT scans was read in a blinded manner by 2 radiologists, and the kappa coefficient was used to assess their interreader reliability. One of the radiologists read the 173 available pairs of radiographs and CT scans performed at baseline. Results After training, interreader reliability was moderate for sacroiliitis grading on radiographs (κ = 0.59), excellent on CT scans (κ = 0.91), and excellent for ascertaining sacroiliitis on both radiographs (κ = 1) and CT scans (κ = 0.96). The first and second readers considered the quality of imaging to be excellent in 66% and 67%, respectively, of the radiographs (κ = 0.88) and in 93% and 92%, respectively, of the CT scans (κ = 0.93). Concordance between radiographs and CT scans was low for sacroiliitis grading (κ = 0.08) or ascertainment (κ = 0.16). Definite sacroiliitis was ascertained on radiographs in 6 patients (3.5%) (confirmed by CT scans in 4 patients) and on CT scans in 32 patients (18.5%). A history of uveitis was associated with definite sacroiliitis on radiographs (P = 0.04) and CT scans (P < 0.0001). Conclusion Definite sacroiliitis was underestimated by radiography, as compared to CT scanning. CT scanning should facilitate the diagnosis of ankylosing spondylitis in patients with suspected SpA. Copyright © 2012 by the American College of Rheumatology.


Leone M.,Service d'anesthesie et de reanimation | Leone M.,Aix - Marseille University | Bechis C.,Service d'anesthesie et de reanimation | Baumstarck K.,Aix - Marseille University | And 12 more authors.
Intensive Care Medicine | Year: 2014

Background: In patients with severe sepsis, no randomized clinical trial has tested the concept of de-escalation of empirical antimicrobial therapy. This study aimed to compare the de-escalation strategy with the continuation of an appropriate empirical treatment in those patients.Methods: This was a multicenter non-blinded randomized noninferiority trial of patients with severe sepsis who were randomly assigned to de-escalation or continuation of empirical antimicrobial treatment. Recruitment began in February 2012 and ended in April 2013 in nine intensive care units (ICUs) in France. Patients with severe sepsis were assigned to de-escalation (n = 59) or continuation of empirical antimicrobial treatment (n = 57). The primary outcome was to measure the duration of ICU stay. We defined a noninferiority margin of 2 days. If the lower boundary of the 95 % confidence interval (CI) for the difference in patients assigned to the de-escalation group was less than 2 days, as compared with that of patients assigned to the continuation group, de-escalation was considered to be noninferior to the continuation strategy. Secondary outcomes included mortality at 90 days, occurrence of organ failure, number of superinfections, and number of days with antibiotics during the ICU stay.Results: The median duration of ICU stay was 9 [interquartile range (IQR) 5–22] days in the de-escalation group and 8 [IQR 4–15] days in the continuation group, respectively (P = 0.71). The mean difference was 3.4 (95 % CI −1.7 to 8.5). A superinfection occurred in 16 (27 %) patients in the de-escalation group and six (11 %) patients in the continuation group (P = 0.03). The numbers of antibiotic days were 9 [7–15] and 7.5 [6–13] in the de-escalation group and continuation group, respectively (P = 0.03). Mortality was similar in both groups.Conclusion: As compared to the continuation of the empirical antimicrobial treatment, a strategy based on de-escalation of antibiotics resulted in prolonged duration of ICU stay. However, it did not affect the mortality rate. © 2014, Springer-Verlag Berlin Heidelberg and ESICM.


Simeoni U.,Hopital la Conception | Simeoni U.,French Institute of Health and Medical Research | Ligi I.,Hopital la Conception | Ligi I.,French Institute of Health and Medical Research | And 3 more authors.
Pediatric Nephrology | Year: 2011

Epidemiological and experimental studies show that the risk of cardiovascular and metabolic diseases at adulthood is inversely related to the weight at birth. Although with less evidence, low birth weight has been suggested to increase the risk of chronic kidney disease (CKD). It is well established that the developmental programming of arterial hypertension and of renal disease involves in particular renal factors, especially nephron endowment, which is reduced in low birth weight and maternal diabetes situations. Experimental studies, especially in rodents, have demonstrated the long-term influence of postnatal nutrition and/or postnatal growth on cardiovascular, metabolic and renal functions, while human data are scarce on this issue. Vascular and renal diseases appear to have a "multihits" origin, with reduced nephron number the initial hit and rapid postnatal growth the second hit. This review addresses the current understanding of the role of the kidney, both as a mechanism and as a target, in the developmental origins of adult disease theory, with a particular focus on the long-term effects of postnatal growth and nutrition. © 2010 IPNA.


Balandraud P.,Hopital la Conception | Gregoire E.,Hopital la Conception | Cazeres C.,Hopital la Conception | Le Treut Y.-P.,Hopital la Conception
American Journal of Surgery | Year: 2011

Background: Hepatolithiasis (HL) is a rare disease in Western countries. The aim of our study was to investigate a possible relation between the development of right HL and abnormalities of the hepatic duct confluence. Material and methods: Fourteen patients who presented with localized right-sided HL were included in this study. The anatomy of hepatic duct confluence in this group of patients was analyzed and compared with the anatomy of hepatic duct confluence in the general population. Results: The Presence of a shift of 1 of the 2 sectorial right ducts was significantly associated with right-sided HL (P = .003). Conclusions: The shift of a sectorial right duct must be considered as one of the anatomic causes of HL. This finding must be considered when surgical treatment of HL is planned. © 2011 Elsevier Inc.

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