Development of a composite endpoint for randomized controlled trials in pancreaticoduodenectomy

World Journal of Surgery
Marielle M E CoolsenS W M Olde Damink

Abstract

Few randomized controlled trials (RCTs) have been performed in patients undergoing pancreaticoduodenectomy (PD). An important factor contributing to this is the large number of patients needed to adequately power RCTs for relevant clinical single endpoints. A PD-specific composite endpoint (CEP) could solve this problem. The aim of the present study was to develop a PD-specific CEP, consisting of complications related to PD, allowing reduction in sample sizes and improving the ability to compare outcomes. PD-specific CEP components were selected after a systematic review of the literature and consensus between 25 international pancreatic surgeons. Ultimately, prospective cohorts of patients who underwent PD in two high-volume HPB centers (London, UK, and Maastricht, NL) were used to assess the event rate and effect of implementing a PD-specific CEP. From a total of 18 single-component endpoints, intra-abdominal abscess, sepsis, post-PD hemorrhage, bile leakage, gastrojejunostomy leakage, leakage of the pancreatic anastomosis, delayed gastric emptying, and operative mortality within 90 days were selected to be included the PD-specific CEP. All eight components had consensus definitions and a Dindo-Clavien classification of 3 or ...Continue Reading

References

Jan 20, 2000·The New England Journal of Medicine·UNKNOWN Heart Outcomes Prevention Evaluation Study InvestigatorsG Dagenais
May 22, 2003·JAMA : the Journal of the American Medical Association·Nick FreemantleCarl Griffin
Jul 9, 2005·Surgery·Claudio BassiUNKNOWN International Study Group on Pancreatic Fistula Definition
May 19, 2006·Journal of Hepato-biliary-pancreatic Surgery·Antonio Ramos-De la Medina, Michael G Sarr
Sep 8, 2006·Digestive Diseases and Sciences·Toshimi Kaido
Nov 23, 2006·Journal of Gastrointestinal Surgery : Official Journal of the Society for Surgery of the Alimentary Tract·Jordan M WinterCharles J Yeo
Apr 4, 2007·BMJ : British Medical Journal·Ignacio Ferreira-GonzálezGordon H Guyatt
Jun 19, 2007·Journal of Clinical Epidemiology·Ignacio Ferreira-GonzálezGordon H Guyatt
Aug 8, 2008·Current Opinion in Organ Transplantation·Kenneth Washburn
Jul 30, 2009·Annals of Surgery·Steven M StrasbergWilliam G Hawkins
Aug 13, 2009·The British Journal of Surgery·M A J van den BroekS W M Olde Damink
Jan 15, 2010·The New England Journal of Medicine·Niels A van der GaagDirk J Gouma
Jan 21, 2010·JAMA : the Journal of the American Medical Association·George Tomlinson, Allan S Detsky
May 11, 2011·The British Journal of Surgery·M A J van den BroekS W M Olde Damink
Jan 13, 2012·The British Journal of Surgery·R F de WildeUNKNOWN Dutch Pancreatic Cancer Group
Jan 14, 2012·Genetics in Medicine : Official Journal of the American College of Medical Genetics·Elisa J F HouwinkCees van der Vleuten

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Citations

Aug 3, 2017·Journal of Surgical Oncology·David P J van DijkCornelis H C Dejong

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