Preoperative Glucocorticoid Use in Major Hepatectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01997658
Recruitment Status : Recruiting
First Posted : November 28, 2013
Last Update Posted : October 26, 2017
Information provided by (Responsible Party):
Dr. Chad G. Ball, University of Calgary

Brief 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.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
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

Arm Intervention/treatment
Experimental: Methylprednisolone
Injection, 500 mg, single use, over 15 to 20 minutes.
Drug: Methylprednisolone
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).
Drug: Placebo
Patients in the placebo group will receive standard perioperative care and surgery, without preoperative administration of methylprednisolone.
Other Name: Standard surgical care

Primary Outcome Measures :
  1. Total Complication rate [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. Total length of hospital stay [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Elective surgery patients (adults) scheduled to undergo hepatectomy at FMC from May 2013 to May 2015.

Exclusion Criteria:

  • Patients will be excluded if they are unable to give informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01997658

Contact: Chad G. Ball, MD,MSc,FRCSC 403-944-3417
Contact: Susan Isherwood, PhD 403 944 349

Canada, Alberta
Foothills Medical Centre Recruiting
Calgary, Alberta, Canada, T2N2T9
Sponsors and Collaborators
University of Calgary
Principal Investigator: Chad G. Ball, MD,MSc,FRCSC University of Calgary, Calgary, Alberta, Canada.

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr. Chad G. Ball, Assistant Professor, University of Calgary Identifier: NCT01997658     History of Changes
Other Study ID Numbers: REB 13 - 0294
First Posted: November 28, 2013    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017

Keywords provided by Dr. Chad G. Ball, University of Calgary:
Total complication rate

Additional relevant MeSH terms:
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents