Transluminal endoscopic step-up approach versus minimally invasive surgical step-up approach in patients with infected necrotising pancreatitis (TENSION trial): design and rationale of a randomised controlled multicenter trial [ISRCTN09186711]

BMC Gastroenterology

Study Protocol

Marcel GW Dijkgraaf¹  Frank P Vleggaar²  Paul Fockens³  Rogier P Voermans³  Sandra van Brunschot⁴  Janneke van Grinsven⁴  Tom Seerden⁵  Erik J Schoon⁶  Marco J Bruno⁷  Jan-Werner Poley⁷  G Willemien Erkelens⁸  Ben J Witteman⁹  Maarten A Meijssen^1,10  Mohammed Hadithi^1,11  Rogier J de Ridder^1,12  Jan Willem A Straathof^1,13  Jeroen JM Jansen^1,14  BW Marcel Spanier^1,15  Robin Timmer^1,16  Chris J Mulder^1,17  Hein G Gooszen^1,18  Stefan A Bouwense^1,19  Vincent C Cappendijk^2,20  Thomas L Bollen^2,21  Krijn P van Lienden^2,22  Johan S Laméris^2,22  Cornelis H Dejong^2,23  Camiel Rosman^2,24  Casper H van Eijck^2,25  Vincent B Nieuwenhuis^2,26  Koop Bosscha^2,27  Alexander F Schaapherder^2,28  Esther C Consten^2,29  Eric R Manusama^3,30  Niels G Venneman^3,31  Harry van Goor^3,32  Joris J Scheepers^3,33  Sijbrand H Hofker^3,34  Jan-Willem Haveman^3,34  Hjalmar C van Santvoort^3,35  Olaf J Bakker^3,35  Marc GH Besselink^3,36  Marja A Boermeester^3,36 

[1] Clinical Research Unit, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands;Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, The Netherlands;Department of Gastroenterology and Hepatology, University of Amsterdam, Amsterdam, The Netherlands;Department of Gastroenterology and Hepatology, University of Amsterdam, Amsterdam, The Netherlands;Department of OR/Evidence Based Surgery, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands;Department of Gastroenterology, Amphia Hospital, Breda, The Netherlands;Department of Gastroenterology, Catharina Hospital, Eindhoven, The Netherlands;Department of Gastroenterology, Erasmus MC, University Medical Center, Rotterdam, The Netherlands;Department of Gastroenterology, Gelre Hospital, Apeldoorn, The Netherlands;Department of Gastroenterology, Hospital Gelderse Vallei, Ede, The Netherlands;Department of Gastroenterology, Isala Clinics, Zwolle, The Netherlands;Department of Gastroenterology, Maasstad Hospital, Rotterdam, The Netherlands;Department of Gastroenterology, Maastricht University Medical Center, Maastricht, The Netherlands;Department of Gastroenterology, Máxima Medical Center, Veldhoven, The Netherlands;Department of Gastroenterology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands;Department of Gastroenterology, Rijnstate Hospital, Arnhem, The Netherlands;Department of Gastroenterology, St Antonius Hospital, Nieuwegein, The Netherlands;Department of Gastroenterology, VU Medical Center, Amsterdam, The Netherlands;Department of OR/Evidence Based Surgery, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands;Department of OR/Evidence Based Surgery, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands;Department of Surgery, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands;Department of Radiology, Jeroen Bosch Hospital, ‘s-Hertogenbosch, The Netherlands;Department of Radiology, St Antonius Hospital, Nieuwegein, The Netherlands;Department of Radiology, University of Amsterdam, Amsterdam, The Netherlands;Department of Surgery and NUTRIM School for Nutrition, Toxicology and Metabolism, Maastricht University Medical Center, Maastricht, The Netherlands;Department of Surgery, Canisius-Wilhelmina Hospital, Nijmegen, The Netherlands;Department of Surgery, Erasmus MC, University Medical Center, Rotterdam, The Netherlands;Department of Surgery, Isala Clinics, Zwolle, The Netherlands;Department of Surgery, Jeroen Bosch Hospital, ‘s-Hertogenbosch, The Netherlands;Department of Surgery, Leiden University Medical Center, Leiden, The Netherlands;Department of Surgery, Meander Medical Center, Amersfoort, The Netherlands;Department of Surgery, Medical Center Leeuwarden, Leeuwarden, The Netherlands;Department of Surgery, Medisch Spectrum Twente, Enschede, The Netherlands;Department of Surgery, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands;Department of Surgery, Reinier de Graaf Group, Delft, The Netherlands;Department of Surgery, University Medical Center Groningen, Groningen, The Netherlands;Department of Surgery, University Medical Center Utrecht, Utrecht, The Netherlands;Department of Surgery, University of Amsterdam, Amsterdam, The Netherlands;

关键词: Acute pancreatitis;    Necrotising;    Treatment;    Drainage;    Trial;    Endoscopy;    Minimally invasive;    Surgery;    Necrosectomy;    Pancreas;   

DOI  :  10.1186/1471-230X-13-161

 received in 2013-10-08, accepted in 2013-11-13,  发布年份 2013

来源: Springer

【 摘 要 】

BackgroundInfected necrotising pancreatitis is a potentially lethal disease that nearly always requires intervention. Traditionally, primary open necrosectomy has been the treatment of choice. In recent years, the surgical step-up approach, consisting of percutaneous catheter drainage followed, if necessary, by (minimally invasive) surgical necrosectomy has become the standard of care. A promising minimally invasive alternative is the endoscopic transluminal step-up approach. This approach consists of endoscopic transluminal drainage followed, if necessary, by endoscopic transluminal necrosectomy. We hypothesise that the less invasive endoscopic step-up approach is superior to the surgical step-up approach in terms of clinical and economic outcomes.Methods/DesignThe TENSION trial is a randomised controlled, parallel-group superiority multicenter trial. Patients with (suspected) infected necrotising pancreatitis with an indication for intervention and in whom both treatment modalities are deemed possible, will be randomised to either an endoscopic transluminal or a surgical step-up approach. During a 4 year study period, 98 patients will be enrolled from 24 hospitals of the Dutch Pancreatitis Study Group. The primary endpoint is a composite of death and major complications within 6 months following randomisation. Secondary endpoints include complications such as pancreaticocutaneous fistula, exocrine or endocrine pancreatic insufficiency, need for additional radiological, endoscopic or surgical intervention, the need for necrosectomy after drainage, the number of (re-)interventions, quality of life, and total direct and indirect costs.DiscussionThe TENSION trial will answer the question whether an endoscopic step-up approach reduces the combined primary endpoint of death and major complications, as well as hospital stay and related costs compared with a surgical step-up approach in patients with infected necrotising pancreatitis.

【 授权许可】

CC BY   
© van Brunschot et al.; licensee BioMed Central Ltd. 2013