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1. Pancreatoduodenectomy with or without prophylactic falciform ligament wrap around the gastroduodenal artery stump for prevention of pancreatectomy hemorrhage

Author

Benjamin Müssle, Leonie Zühlke, Ann Wierick, Dorothée Sturm, Xina Grählert, Marius Distler, Nuh N. Rahbari, Jürgen Weitz, and Thilo Welsch

Subjects
Falciform ligament, Pancreatoduodenectomy, Pancreatic fistula, Hemorrhage, Gastroduodenal artery, Medicine (General), R5-920
Abstract

Abstract Background The purpose of this study is to evaluate whether wrapping of the pedicled falciform ligamentum flap around the gastroduodenal artery (GDA) stump/hepatic artery can significantly decrease the incidence of erosion hemorrhage after pancreatoduodenectomy (PD). Methods/design This is a randomized controlled multicenter trial involving 400 patients undergoing PD. Patients will be randomized into two groups. The intervention group consists of 200 patients with a prophylactic wrapping of the GDA stump using the pedicled falciform ligament. The control group consists of 200 patients without the wrap. The primary endpoint is the rate of postoperative erosion hemorrhage of the GDA stump or hepatic artery within 3 months. The secondary endpoints are postpancreatectomy hemorrhage stratified according to the texture of the pancreas, postoperative pancreatic fistula (POPF), postoperative rate of therapeutic interventions, morbidity, and mortality. Discussion Only few retrospective studies investigated the effectiveness of a falciform ligament wrap around the GDA for prevention of erosion hemorrhage. Erosion hemorrhage occurs in up to 6–9% of cases after PD and is most frequently evoked by a POPF. Erosion hemorrhage is associated with a remarkable mortality of over 30%. The rate of hemorrhage after performing the wrap is reported to be low. However, there exist no prospectively controlled data to support its general use. Therefore, the presented randomized controlled trial will provide clinically relevant evidence of the effectiveness of the wrap with statistical significance. Trial registration clinicaltrials.gov, NCT02588066; Registered on 27 October 2015.

Published
2018
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2. Typical investigational medicinal products follow relatively uniform regulations in 10 European Clinical Research Infrastructures Network (ECRIN) countries

Author

Jean-Marc Husson, Timothy O'Brien, Fernando de Andres, Charlotte Asker-Hagelberg, Béatrice Barraud, Nuria Sanz, Zsuza Temesvari, Karl-Heinz Huemer, Sue Bourne, Gabriele Dreier, German Kreis, Adeeba Asghar, Hanna Johansson, Jacques Demotes-Mainard, György Blaskó, Siobhan Gaynor, Xina Grählert, Arrigo Schieppati, Jane Byrne, Kate Whitfield, Gabriella Kardos, Christian Gluud, Margaret Cooney, Steffen Thirstrup, Wolfgang Kuchinke, Christine Kubiak, Sebastian Geismann, Christian Libersa, Copenhagen Trial Unit (CTU), Copenhagen University Hospital-Centre for Clinical Intervention Research-Danish Clinical Research Infrastructures Network, Institut Thématique Santé Publique, Institut National de la Santé et de la Recherche Médicale (INSERM), Education and Research Centre, Wythenshawe Hospital, Medizinische Universität Wien = Medical University of Vienna, Danish Medicines Agency, CIC CHU ( Lille)/inserm, Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille, Droit et Santé, KKS, Medizinische Fakultät Carl Gustav Carus, Studienzentrum-Clinical Trials Unit, University Medical Centre Freiburg, KKS-Duesseldorf (KKSD), Heinrich Heine Universität Düsseldorf = Heinrich Heine University [Düsseldorf], Ministry of Health Social and Family Affairs, Medical Research Council (HECRIN), National University of Ireland [Galway] (NUI Galway), Irish Clinical Research Infrastructures Network (ICRIN), Istituto di Ricerche Farmacologiche Mario Negri (IRFMN), Departemento de Farmacologia (Medicina), Universidad Complutense de Madrid = Complutense University of Madrid [Madrid] (UCM), Hospital Clinic i Provincial de Barcelona (SCReN), Karolinska Trial Alliance, UK Clinical Research Collaboration, NIHR Clinical Research Network Coordination Centre, European Forum for Good Clinical Practice, ECRIN is a project funded by the EU Sixth and Seventh Framework Programmes., and BMC, Ed.

Subjects
Consumer Product Safety, bias, Biomedical Research, Device Approval, International Cooperation, Population, empirical-evidence, Medicine (miscellaneous), Accounting, Guidelines as Topic, 030204 cardiovascular system & hematology, 03 medical and health sciences, 0302 clinical medicine, Surveys and Questionnaires, Medicine, Humans, Pharmacology (medical), 030212 general & internal medicine, education, Drug Approval, Health policy, education.field_of_study, lcsh:R5-920, business.industry, Gyógyszerészeti tudományok, Research, Health Policy, Orvostudományok, Drugs, Investigational, Directive, 3. Good health, Product (business), Europe, Clinical research, quality, Multinational corporation, [SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie, randomized-trials, Government Regulation, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, Guideline Adherence, business, lcsh:Medicine (General)
Abstract

Background In order to facilitate multinational clinical research, regulatory requirements need to become international and harmonised. The EU introduced the Directive 2001/20/EC in 2004, regulating investigational medicinal products in Europe. Methods We conducted a survey in order to identify the national regulatory requirements for major categories of clinical research in ten European Clinical Research Infrastructures Network (ECRIN) countries-Austria, Denmark, France, Germany, Hungary, Ireland, Italy, Spain, Sweden, and United Kingdom-covering approximately 70% of the EU population. Here we describe the results for regulatory requirements for typical investigational medicinal products, in the ten countries. Results Our results show that the ten countries have fairly harmonised definitions of typical investigational medicinal products. Clinical trials assessing typical investigational medicinal products require authorisation from a national competent authority in each of the countries surveyed. The opinion of the competent authorities is communicated to the trial sponsor within the same timelines, i.e., no more than 60 days, in all ten countries. The authority to which the application has to be sent to in the different countries is not fully harmonised. Conclusion The Directive 2001/20/EC defined the term 'investigational medicinal product' and all regulatory requirements described therein are applicable to investigational medicinal products. Our survey showed, however, that those requirements had been adopted in ten European countries, not for investigational medicinal products overall, but rather a narrower category which we term 'typical' investigational medicinal products. The result is partial EU harmonisation of requirements and a relatively navigable landscape for the sponsor regarding typical investigational medicinal products.

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