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Preoperative Glucocorticoid Use in Major Hepatectomy

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by University of Calgary
Sponsor:
Information provided by (Responsible Party):
Dr. Chad G. Ball, University of Calgary
ClinicalTrials.gov Identifier:
NCT01997658
First received: May 14, 2013
Last updated: October 30, 2014
Last verified: October 2014
  Purpose

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 Intervention Phase
Complications
Drug: Methylprednisolone
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Preoperative Glucocorticoid Use in Major Hepatectomy - A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • Total Complication rate [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total length of hospital stay [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: October 2014
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01997658

Contacts
Contact: Chad G. Ball, MD,MSc,FRCSC 403-944-3417 ball.chad@gmail.com
Contact: Sana U. Bhatti, MBBS,MRCSEd 403-607-2716 sanaullahbhatti@yahoo.com

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

No publications provided

Responsible Party: Dr. Chad G. Ball, Assistant Professor, University of Calgary
ClinicalTrials.gov Identifier: NCT01997658     History of Changes
Other Study ID Numbers: REB 13 - 0294
Study First Received: May 14, 2013
Last Updated: October 30, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Calgary:
Glucocorticoids
Total complication rate
Hepatectomy.

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

ClinicalTrials.gov processed this record on November 25, 2014