Preoperative Glucocorticoid Use in Major Hepatectomy
Status:
Completed
Trial end date:
2018-10-30
Target enrollment:
Participant gender:
Summary
Background: Reducing postoperative complications remains a dominant challenge for all
clinicians. By minimizing the incidence of adverse outcomes, health care costs and patient
recovery can be improved. A number of studies have documented that fewer postoperative
adverse events occur with the preoperative use of glucocorticoids (GC). Two small manuscripts
support the use of GC with particular reference to liver resection.
Major hepatectomy can be associated with numerous adverse outcomes (hemorrhage, bile leak,
liver failure, wound infection other infectious complications). This rate approaches 54% in
some trials. Additionally, the liver is responsible for numerous metabolic functions and
actively participates in the acute phase response via the generation of inflammatory
mediators and cytokines. Glucocorticoids play an important role in suppressing the
over-synthesis of pro-inflammatory cytokines and therefore may assist in reducing
postoperative complications. These pro-inflammatory cytokines recruit leukocytes at the site
of injury, leading to hepatic parenchymal cell damage. Decreasing pro-inflammatory cytokine
ratio may therefore reduce hepatic damage.
Methods: The investigators will complete a randomized controlled trial evaluating the
incidence of postoperative complications and overall hospital length of stay in adult
patients following preoperative vs. no administration of 500 mg of methylprednisolone (MP)
within 30 minutes of starting a hepatectomy. This trial will employ block randomization and
intention to treat protocols. Four HPB surgeons at University of Calgary will participate in
the trial with a planned inclusion of all patients scheduled to undergo hepatectomy in a
period of 2 years.
Analysis: Standard statistical analysis will include normally or near-normally distributed
variables reported as means and non-normally distributed variables as medians. Means will be
compared using the student's t test and medians using the Mann-Whitney U test. Differences in
proportions among categorical data will be assessed using Fischer's exact test. A p value <
0.05 will represent statistical significance for all comparisons.
Hypothesis: Preoperative GC administration will decrease the incidence of postoperative
complications and overall hospital length of stay following hepatectomy.
Potential Impact: Health care utilization and economics are an expanding area of importance.
Reducing post-hepatectomy complications are crucial to this end.