Development of a Composite Endpoint for Randomized Controlled Trials in Pancreaticoduodenectomy

M.M.E. Coolsen, S.H.E.M. Clermonts, R.M. van Dam, B. Winkens, M. Malagó, G.K. Fusai, C.H.C. Dejong, S.W.M. Olde Damink

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Abstract

BACKGROUND: Few randomized controlled trials (RCTs) have been performed patients undergoing pancreaticoduodenectomy (PD). An important factor contributing to this is the large number of patients needed to RCTs for relevant clinical single endpoints. A PD-specific composite (CEP) could solve this problem. The aim of the present study was to PD-specific CEP, consisting of complications related to PD, allowing sample sizes and improving the ability to compare outcomes. METHODS: PD- CEP components were selected after a systematic review of the literature consensus between 25 international pancreatic surgeons. Ultimately, cohorts of patients who underwent PD in two high-volume HPB centers and Maastricht, NL) were used to assess the event rate and effect of a PD-specific CEP. RESULTS: From a total of 18 single-component intra-abdominal abscess, sepsis, post-PD hemorrhage, bile leakage, gastrojejunostomy leakage, leakage of the pancreatic anastomosis, emptying, and operative mortality within 90 days were selected to be PD-specific CEP. All eight components had consensus definitions and a Dindo-Clavien classification of 3 or more. The incidence of the PD- was 24.7 % in the Maastricht cohort and 23.3 % in the London cohort. incidence rates led to a twofold reduction in the theoretical calculated size for an adequately powered RCT on PD using this CEP as a primary CONCLUSIONS: The proposed PD-specific CEP enables clinical investigators adequately power RCTs on PD and increases the feasibility, utility in meta-analysis.
Original languageEnglish
Pages (from-to)1468-1475
JournalWorld Journal of Surgery
Volume38
Issue number6
DOIs
Publication statusPublished - 1 Jan 2014

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