Preoperative Glucocorticoid Use in Major Hepatectomy

NCT01997658 | Completed Phase 2

• 1 other identifier: REB 13 - 0294
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Complications

Keywords

Glucocorticoids; Total complication rate; Hepatectomy.

Outcome Measures

Primary Outcomes (1)

• Total Complication rate

  1 month

Secondary Outcomes (1)

• Total length of hospital stay

  3 months

Study Arms (2)

Methylprednisolone

EXPERIMENTAL

Injection, 500 mg, single use, over 15 to 20 minutes.

Drug: Methylprednisolone

Control

PLACEBO COMPARATOR

In Control arm, patients will receive the standardized surgical treatment without receiving methylprednisolone preoperatively (placebo).

Drug: Placebo

Interventions

Methylprednisolone DRUG

Patients in Methylprednisolone arm will receive injection methylprednisolone 500 mg I/V over 15 to 20 minutes, single dose, 30 minutes before starting surgery.

Also known as: Solu-Medrol

Methylprednisolone

Placebo DRUG

Patients in the placebo group will receive standard perioperative care and surgery, without preoperative administration of methylprednisolone.

Also known as: Standard surgical care

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

Foothills Medical Centre

Calgary, Alberta, T2N2T9, Canada

Location

Related Publications (1)

• Bressan AK, Roberts DJ, Bhatti SU, Dixon E, Sutherland FR, Bathe OF, Ball CG. Preoperative single-dose methylprednisolone versus placebo after major liver resection in adults: protocol for a randomised controlled trial. BMJ Open. 2015 Oct 7;5(10):e008948. doi: 10.1136/bmjopen-2015-008948.

  PMID: 26446165 DERIVED

MeSH Terms

Interventions

Methylprednisolone; Methylprednisolone Hemisuccinate

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Chad G. Ball, MD,MSc,FRCSC

  University of Calgary, Calgary, Alberta, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 14, 2013
• First Posted: November 28, 2013
• Study Start: October 1, 2014
• Primary Completion: October 30, 2018
• Study Completion: October 30, 2018
• Last Updated: April 28, 2021

Record last verified: 2021-04

Locations

CA (1)