Surrogate endpoints in liver surgery related trials: a systematic review of the literature.

I.L. Mpabanzi, K.M. van Mierlo, M. Malago, C.H.C. Dejong, D. Lytras, S. Olde Damink

Research output: Contribution to journalArticleAcademicpeer-review

5 Citations (Scopus)

Abstract

BACKGROUND: Although the safety of liver surgery has improved enormously, hepatic surgery continues to face challenging complications. Therefore, improvements supported by evidence-based guidelines are still required. The conduct of randomized controlled trials in liver surgery using dichotomous outcomes requires a large sample size. The use of surrogate endpoints (SEPs) reduces sample size but SEPs should be validated before use. AIM: The aim of this review was to summarize the SEPs used in hepatic surgery related trials, their definitions and recapitulating the evidence validating their use. METHOD: A systematic computerized literature search in the biomedical database PubMed using the MeSH terms 'hepatectomy' or 'liver resection' or 'liver transection' was conducted. Search was limited to papers written in the English language and published between 1 January 2000 and 1 January 2010. RESULTS: A total of 593 articles met the search terms and 49 articles were included in the final selection. Standard biochemical liver functions tests were the most frequently used SEP (32 of 49 the studies). The used definitions of SEPs varied greatly among the studies. Most studies referred to earlier published material to justify their choice of SEP. However, no validating studies were found. CONCLUSION: Many SEPs are used in liver surgery trials however there is little evidence validating them.
Original languageEnglish
Pages (from-to)327-336
Number of pages10
JournalHPB
Volume15
Issue number5
DOIs
Publication statusPublished - May 2013

Keywords

  • RANDOMIZED CONTROLLED-TRIALS
  • ISCHEMIA-REPERFUSION INJURY
  • INCREASING PROTEIN RBPI(21)
  • HEPATIC INFLOW OCCLUSION
  • GREEN ELIMINATION RATE
  • ISCHEMIA/REPERFUSION INJURY
  • CLINICAL-TRIALS
  • BIOCHEMICAL FAILURE
  • CIRRHOTIC-PATIENTS
  • PRINGLE MANEUVER

Cite this