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  • 1
    Keywords: Study protocol, PANUSCO, pancreatic adenocarcinoma
    Abstract: Background: Pancreatic cancer is an extremely aggressive malignancy. Subjects are afflicted with a variety of disconcerting symptoms, including profound cachexia. Recent data indicate that the outcome of oncological patients suffering from cancer cachexia could be improved by parenteral nutrition and that parenteral nutrition results in an improvement of quality of life and in prolonged survival. Currently, there is no recommendation of routine use of parenteral nutrition. Furthermore, there is no clear recommendation for 2nd line therapy (or higher) for pancreatic adenocarcinoma but often asked for. Methods/Design: PANUSCO is an open label, controlled, prospective, randomized, multicentre phase IIIb trial with two parallel arms. All patients will be treated with 5-fluorouracil, folinic acid and oxaliplatin on an outpatient basis at the study sites. Additionally, all patients will receive best supportive nutritional care (BSNC). In the experimental group BSNC will be expanded with parenteral nutrition (PN). In contrast, patients in the control group obtain solely BSNC. Parenteral nutrition will be applied overnight and at home by experienced medical staff. A total of 120 patients are planned to be enrolled. Primary endpoint is the comparison of the treatment groups with respect to event-free survival (EFS), defined as the time from randomization till time to development of an event defined as either an impairment (change from baseline of at least ten points in EORTC QLQ-C30, functional domain total score) or withdrawal due to fulfilling the special defined stopping criteria for chemotherapy as well as for nutritional intervention (NI) or death from any cause (whichever occurs first). Discussion: The aim of this clinical trial is to evaluate whether parenteral nutrition in combination with defined 2nd line or higher chemotherapy has an impact on quality of life for patients suffering from pancreatic adenocarcinoma. Trial registration: Current Controlled Trials ISRCTN60516908.
    Type of Publication: Journal article published
    PubMed ID: 19943918
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  • 2
    Electronic Resource
    Electronic Resource
    Der Chirurg 71 (2000), S. 615-625 
    ISSN: 1433-0385
    Keywords: Keywords: Evidence-based medicine ; Surgical research ; Randomized controlled trials. ; Schlüsselwörter: Evidenz-basierte Medizin (EBM) ; chirurgische Forschung ; randomisierte kontrollierte Studien (RCT).
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Description / Table of Contents: Zusammenfassung. Die Anwendung der besten Therapieoption nach dem derzeitigen Stand des Wissens wird als Evidenz-basierte Medizin (EBM) bezeichnet. Angesichts der Kostenexplosion im Gesundheitswesen soll die EBM darüber hinaus ihre speziellen Beiträge zum gezielten und ökonomischen Einsatz der knapper werdenden Ressourcen und zur Qualitätssicherung in der Medizin leisten. Dies gilt selbstverständlich auch für die operativen Fächer und kann hier als Evidenz-basierte Chirurgie bezeichnet werden. Chirurgen müssen in dieser Richtung verstärkt ihre „Hausaufgaben“ machen und in besonderem Maße randomisierte kontrollierte klinische Studien (Goldstandard mit der höchsten klinischen Evidenz) durchführen, um diesen Ansprüchen in der Zukunft gerecht zu werden. Diese Evidenz-basierte Therapie ist wichtig für den Erhalt und insbesondere für die Fort- und Weiterentwicklung einer hochqualifizierten und zugleich qualitätsgesicherten Chirurgie im neuen Millennium. Der vorliegende Artikel definiert EBM und deren Bedeutung für die Chirurgie. Darüber hinaus werden wesentliche Grundlagen bei der praktischen Durchführung von klinisch randomisierten kontrollierten Studien und deren spezifische Probleme in der Chirurgie diskutiert.
    Notes: Abstract. The employment of the optimal therapeutic option according to the best current knowledge is called evidence-based medicine (EBM). Moreover, considering the cost explosion in public health systems, EBM should contribute towards economical and targeted use of the restricted resources and towards quality assurance in medicine. Obviously, this is applicable to the operative specialties and can be termed as evidence-based surgery. Surgeons have to do their “homework“ about this subject and to perform randomized controlled trials (the gold standard with the greatest evidence) on a large scale, in order to come up to this expectation in future. Evidence-based therapy is essential for the preservation and especially for the further development and evolution of high-quality surgery with, at the same time, quality assurance in the new millenium. This article presents the definition of EBM and its implication in the operative fields. Fundamental principles for the practical conduct of clinical randomized controlled trials are defined and the specific problems in surgery are discussed.
    Type of Medium: Electronic Resource
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