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International Study Group (international + study_group)

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Medical Sciences	100%

Selected Abstracts

Post pancreaticoduodenectomy haemorrhage: outcome prediction based on new ISGPS Clinical severity grading

HPB, Issue 5 2008
G. Rajarathinam
Abstract Objective & background data. Mortality following pancreatoduodenectomy (PD) has fallen below 5%, yet morbidity remains between 30 and 50%. Major haemorrhage following PD makes a significant contribution to this ongoing morbidity and mortality. The aim of the present study was to validate the new International Study Group of Pancreatic Surgery (ISGPS) Clinical grading system in predicting the outcome of post pancreaticoduodenectomy haemorrhage (PPH). Material and methods. Between January 1998 and December 2007 a total of 458 patients who underwent Whipple's pancreaticoduodenectomy in our department were analysed with regard to haemorrhagic complications. The onset, location and severity of haemorrhage were classified according to the new criteria developed by an ISGPS. Risk factors for haemorrhage, management and outcome were analysed. Results. Severe PPH occurred in 14 patients (3.1%). Early haemorrhage (<24 hours) was recorded in five (36%) patients, and late haemorrhage (>24 hours) in nine (64%) patients. As per Clinical grading of ISGPS 7 (50%) belongs to Grade C and 7 (50%) belongs to Grade B. Haemostasis was attempted by surgery in 10 (71%) patients; angioembolisation was successful in two (14%) and endotherapy in one (7%) patient. The overall mortality is 29%(n=4). Age >60 years (p=0.02), sentinel bleeding (p=0.04), pancreatic leak (p=0.04) and ISGPS Clinical grade C (p=0.02) were associated with increased mortality. Conclusion. Early haemorrhage was mostly managed surgically with better outcome when endoscopy is not feasible. Late haemorrhage is associated with high mortality due to pancreatic leak and sepsis. ISGPS Clinical grading of PPH is useful in predicting the outcome. [source]

Critical role of ribavirin for the achievement of early virological response to HCV therapy in HCV/HIV-coinfected patients

JOURNAL OF VIRAL HEPATITIS, Issue 6 2007
B. Ramos
Summary., The response to hepatitis C virus (HCV) therapy seems to be lower in HCV/HIV-coinfected patients than in HCV-monoinfected individuals. Given that most pivotal trials conducted in coinfected patients have used the combination of pegylated interferon (pegIFN) along with fixed low doses (800 mg/day) of ribavirin (RBV), it is unclear whether HIV itself and/or suboptimal RBV exposure could explain this poorer outcome. Two well-defined end points of early virological response were evaluated in Peginterferon Ribavirina España Coinfección (PRESCO), a multicentre trial in which the combination of pegIFN plus RBV (1000 mg if body weight <75 kg and 1200 mg if >75 kg) was prescribed to coinfected patients. For comparisons, we used unpublished data from early kinetics in two other large trials, one performed in HIV-negative patients [Pegasys International Study Group (PISG)] in which RBV 1000,1200 mg/day was used and another [AIDS Pegasys Ribavirin Coinfection Trial (APRICOT)] in which HIV-positive patients received fixed low RBV doses (800 mg/day). A total of 348 HCV/HIV-coinfected patients from the PRESCO trial were analysed as well as all patients treated with pegIFN plus RBV, who completed 12 weeks of therapy in the comparative studies (435 in PISG and 268 in APRICOT). Negative serum HCV-RNA at week 4 (which has the highest positive predictive value of sustained virological response, SVR) was attained in 33.3%, 31.2% and 13% of treated patients with HCV genotype 1, respectively, in PRESCO, PISG and APRICOT. For HCV genotypes 2/3, responses were 83.7%, 84.2% and 37%, respectively. A decline lower than 2 log10 at week 12 (which has the highest negative predictive value of SVR) was seen in 25.5%, 19.5% and 37% of HCV genotype-1-infected patients, and in 2.1%, 2.9% and 12% of genotypes-2/3-infected patients, respectively. Prescription of high RBV doses enhances the early virological response to HCV therapy in HCV/HIV-coinfected patients, with results approaching those seen in HCV-monoinfected patients. [source]

Pediatric diffuse large B-cell lymphoma demonstrates a high proliferation index, frequent c-Myc protein expression, and a high incidence of germinal center subtype: Report of the French,American,British (FAB) international study group,

PEDIATRIC BLOOD & CANCER, Issue 3 2008
Rodney R. Miles MD
Abstract Background Diffuse large B-cell lymphoma (DLBCL) makes up 10,20% of pediatric non-Hodgkin lymphoma, and these patients have a significantly better prognosis than adults with DLBCL. The difference in prognosis may be related to clinical, phenotypic, and/or biological differences between adult and pediatric DLBCL. In adult DLBCL, the germinal center (GC) phenotype is associated with a better prognosis than the activated B-cell (ABC) phenotype. However, a high proliferative index and expression of Bcl2 and c-Myc protein have all been associated with worse outcomes. While multiple studies have addressed the phenotype and expression patterns of adult DLBCL, relatively little is known about these biological variables in pediatric DLBCL. The goal of this study was to investigate the proliferative index, the relative frequencies of the GC and non-GC subtypes, and the expression of Bcl2 and c-Myc protein in a cohort of children with DLBCL treated in a uniform manner. Procedure We performed immunohistochemistry (IHC) for MIB1, CD10, Bcl6, MUM1, Bcl2, and c-Myc on DLBCL tissue from children treated uniformly in the FAB LMB96 trial (SFOP LMB96/CCG5961/UKCCSG/NHL 9600). Results Compared to published adult DLBCL studies, pediatric DLBCL demonstrated moderate to high proliferation rates (83%), increased c-Myc protein expression (84%), decreased Bcl2 protein expression (28%), and an increased frequency of the GC phenotype (75%). Conclusions These findings suggest that there are significant biologic differences between pediatric and adult forms of DLBCL, which may contribute to the superior prognosis seen in the pediatric population relative to adult disease. Pediatr Blood Cancer 2008;51:369,374. © 2008 Wiley-Liss, Inc. [source]

Study design of the Trial to Reduce IDDM in the Genetically at Risk (TRIGR)

PEDIATRIC DIABETES, Issue 3 2007
The TRIGR Study Group
Abstract:, The hypothesis for this study is that weaning to an extensively hydrolyzed infant formula will decrease the incidence of type 1 diabetes (T1D), as it does in all relevant animal models for the disease. This will be tested in children who carry risk-associated human leukocyte antigen genotypes and have a first-degree relative with T1D. The trial will use a double-blind, prospective, placebo-controlled intervention protocol, comparing casein hydrolysate with a conventional cow's milk (CM)-based formula. A secondary aim is to determine relationships between CM antibodies, a measure of CM exposure, and diabetes-associated autoantibodies. To achieve an 80% power for the detection of a 40% intervention-induced difference in the development of autoantibodies and subsequent diabetes, the study requires 2032 subjects. A multicenter, international, collaborative effort is necessary to achieve recruitment targets. A collaborative international study group of 78 clinical centers in 15 countries has therefore been assembled for this purpose. [source]