Preoperative Glucocorticoid Use in Major Hepatectomy
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|ClinicalTrials.gov Identifier: NCT01997658|
Recruitment Status : Recruiting
First Posted : November 28, 2013
Last Update Posted : October 26, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Complications||Drug: Methylprednisolone Drug: Placebo||Phase 2 Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Preoperative Glucocorticoid Use in Major Hepatectomy - A Randomized Controlled Trial|
|Study Start Date :||October 2014|
|Estimated Primary Completion Date :||January 2018|
|Estimated Study Completion Date :||January 2018|
Injection, 500 mg, single use, over 15 to 20 minutes.
Patients in Methylprednisolone arm will receive injection methylprednisolone 500 mg I/V over 15 to 20 minutes, single dose, 30 minutes before starting surgery.
Other Name: Solu-Medrol
Placebo Comparator: Control
In Control arm, patients will receive the standardized surgical treatment without receiving methylprednisolone preoperatively (placebo).
Patients in the placebo group will receive standard perioperative care and surgery, without preoperative administration of methylprednisolone.
Other Name: Standard surgical care
- Total Complication rate [ Time Frame: 1 month ]
- Total length of hospital stay [ Time Frame: 3 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01997658
|Contact: Chad G. Ball, MD,MSc,FRCSCfirstname.lastname@example.org|
|Contact: Susan Isherwood, PhD||403 944 email@example.com|
|Foothills Medical Centre||Recruiting|
|Calgary, Alberta, Canada, T2N2T9|
|Principal Investigator:||Chad G. Ball, MD,MSc,FRCSC||University of Calgary, Calgary, Alberta, Canada.|