Skip to main content
main-content

01.06.2014 | Ausgabe 6/2014

World Journal of Surgery 6/2014

Development of a Composite Endpoint for Randomized Controlled Trials in Pancreaticoduodenectomy

Zeitschrift:
World Journal of Surgery > Ausgabe 6/2014
Autoren:
Marielle M. E. Coolsen, Stefan H. E. M. Clermonts, Ronald M. van Dam, Bjorn Winkens, Massimo Malagó, Giuseppe K. Fusai, Cornelis H. C. Dejong, Steven W. M. Olde Damink
Wichtige Hinweise

Electronic supplementary material

The online version of this article (doi:10.​1007/​s00268-013-2421-y) contains supplementary material, which is available to authorized users.
Presented to the Tenth Congress of the European-African Hepatopancreatobiliary Association, Belgrade, Serbia, May 2013.

Abstract

Background

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.

Methods

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.

Results

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 more. The incidence of the PD-specific CEP was 24.7 % in the Maastricht cohort and 23.3 % in the London cohort. These incidence rates led to a twofold reduction in the theoretical calculated sample size for an adequately powered RCT on PD using this CEP as a primary endpoint.

Conclusions

The proposed PD-specific CEP enables clinical investigators to adequately power RCTs on PD and increases the feasibility, comparability, and utility in meta-analysis.

Bitte loggen Sie sich ein, um Zugang zu diesem Inhalt zu erhalten

★ PREMIUM-INHALT
e.Med Interdisziplinär

Mit e.Med Interdisziplinär erhalten Sie Zugang zu allen CME-Fortbildungen und Fachzeitschriften auf SpringerMedizin.de. Zusätzlich können Sie eine Zeitschrift Ihrer Wahl in gedruckter Form beziehen – ohne Aufpreis.

Weitere Produktempfehlungen anzeigen
Zusatzmaterial
Supplementary material 1 (PDF 264 kb)
268_2013_2421_MOESM1_ESM.pdf
Supplementary material 2 (PDF 304 kb)
268_2013_2421_MOESM2_ESM.pdf
Supplementary material 3 (PDF 76 kb)
268_2013_2421_MOESM3_ESM.pdf
Literatur
Über diesen Artikel

Weitere Artikel der Ausgabe 6/2014

World Journal of Surgery 6/2014 Zur Ausgabe
  1. Sie können e.Med Chirurgie 14 Tage kostenlos testen (keine Print-Zeitschrift enthalten). Der Test läuft automatisch und formlos aus. Es kann nur einmal getestet werden.

Neu im Fachgebiet Chirurgie

Mail Icon II Newsletter

Bestellen Sie unseren kostenlosen Newsletter Update Chirurgie und bleiben Sie gut informiert – ganz bequem per eMail.

Bildnachweise