Methylprednisolone for Liver Surgery
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether taking methylprednisolone, a type of steroid, before liver surgery can reduce side effects such as infections and extended hospital stays. Participants will divide into two groups: one will receive methylprednisolone, and the other will not receive any steroids. This trial suits adults planning major liver surgery who have not had issues with steroids before. The goal is to make recovery easier and faster. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but if you are on long-term systemic corticosteroids, you may not be eligible if you've taken them within 30 days before surgery. Other uses of corticosteroids, like inhalers or topical creams, are allowed.
Is there any evidence suggesting that methylprednisolone is likely to be safe for humans?
Research has shown that methylprednisolone, administered before surgery, is generally safe and well-tolerated. Studies suggest that this treatment can reduce the risk of complications after liver surgery. For instance, one study found that methylprednisolone lowered post-surgery issues from 47.3% to 31.2%. Another review found that patients experienced fewer wound infections when given this steroid before surgery.
While some studies have indicated more problems in patients using steroids long-term, this does not increase the risk of death. Overall, methylprednisolone is considered safe, especially for short-term use before surgery.12345Why do researchers think this study treatment might be promising?
Methylprednisolone is unique because it is a corticosteroid that can potentially reduce inflammation and improve recovery times after liver surgery. Most current treatments focus on managing symptoms post-surgery, but methylprednisolone could directly impact the inflammatory response, which is crucial for healing. Researchers are excited about this treatment because it might shorten hospital stays and enhance overall outcomes by effectively controlling inflammation during the critical post-operative period.
What evidence suggests that methylprednisolone might be an effective treatment for reducing surgery side effects?
Research has shown that taking methylprednisolone before liver surgery can greatly reduce complications. In this trial, one group of participants will receive methylprednisolone, while another group will not receive any steroid treatment. One study found that patients who received methylprednisolone had fewer complications (31.2%) compared to those who did not (47.3%). Another study reported similar results, with fewer serious complications in the group that received the drug (26% vs. 46.4%). This treatment reduces inflammation and helps the liver recover faster. Overall, evidence suggests that methylprednisolone can make surgery safer and speed up recovery.34567
Who Is on the Research Team?
Michael D'Angelica, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults (18 or older) who are scheduled to have major planned liver surgery, such as removal of large parts of the liver. People having additional smaller liver procedures at the same time can also join.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Preoperative Treatment
Participants receive methylprednisolone before surgery to test its effect on reducing surgery side effects
Surgery
Participants undergo major hepatectomy
Follow-up
Participants are monitored for 30-day all-cause morbidity after surgery
What Are the Treatments Tested in This Trial?
Interventions
- Methylprednisolone
Trial Overview
The study is testing if giving methylprednisolone (a steroid medication) before major liver surgery helps reduce complications like infections and shortens hospital stays. Participants receive this medicine before their operation.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Find a Clinic Near You
Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer Center
Lead Sponsor
Citations
Preoperative Single-dose Methylprednisolone Prevents ...
There was a significant reduction in the overall incidence of postoperative complications in the methylprednisolone group (31.2% vs 47.3%; P = ...
Impact of preoperative single-dose methylprednisolone on ...
Patients in methylprednisolone group had significantly lower Clavien-Dindo graded complications compared to control (26% versus 46.4%, p = 0.03),predominantly ...
Systematic Review and Meta-Analysis of the Benefit ...
Conclusion: Preoperative administration of steroid in liver resection can promote the recovery of liver function and inhibit the inflammatory response without ...
Impact of perioperative steroid administration in patients ...
Perioperative steroid administration significantly reduces the overall complication rate after elective liver resection without an increased risk of adverse ...
a systematic review and meta-analysis of randomised ...
11 It is currently believed that the use of glucocorticoids can improve the microcirculation of liver tissue and reduce the damage of hepatocytes.12 In the past ...
Systematic Review and Meta-Analysis of the Benefit ... - PMC
Objective: To evaluate the benefit and safety of preoperative administration of steroid in patients undergoing liver resection.
NCT07507643 | A Study of Methylprednisolone in People ...
The purpose of this study is to test whether receiving methylprednisolone before surgery will reduce the side effects of having surgery, ...
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