Actively Recruiting
A Randomized Controlled Trial of Methylprednisolone Versus Standard of Care in Patients Undergoing Major Hepatectomy
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-04-02
750
Participants Needed
19
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether giving methylprednisolone before major liver surgery can reduce side effects such as infections and longer hospital stays. This randomized, phase 3 trial compares methylprednisolone to standard care in patients undergoing major hepatectomy, aiming to improve recovery outcomes after surgery. Participants are randomly assigned to one of two groups: one group receives a single preoperative dose of methylprednisolone, while the other group does not receive steroids. The study focuses on patients having major hepatectomy, which may include additional partial hepatectomy or operative ablation. The treatment is administered before surgery as a single dose. During the study, researchers will monitor participants for complications occurring within 30 days after surgery, including overall morbidity. Assessments include monitoring infections, hospital stay length, and other side effects related to surgery. Participants will be followed for at least 30 days post-surgery to evaluate recovery and safety. The total duration for individual participation depends on surgery scheduling and follow-up visits.
CONDITIONS
Brief Title
A Study of Methylprednisolone in People Having Liver Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of consent
- Scheduled to undergo elective major hepatectomy (trisegmentectomy, total left hepatectomy, or total right hepatectomy)
- May undergo additional partial hepatectomy or operative ablation alongside major hepatectomy
You will not qualify if you...
- Known or documented adverse reactions to methylprednisolone
- Unable to receive methylprednisolone due to other medical conditions
- Long-term systemic corticosteroid use (10 days or more) within 30 days before surgery, except steroids given with preoperative chemotherapy
- Significant chance of unsuccessful surgery due to unresectability
- Expected to have major organ resection other than liver
- Expected to have biliary tree reconstruction via biliary-enteric anastomosis
- Scheduled for insertion of hepatic artery infusion pump device
- Renal dysfunction (creatinine clearance ≤40 mL/min or on dialysis)
- Dependent on mechanical ventilation before surgery
- Pregnant or nursing females
- Known bacterial infection expected at surgery or recent systemic antibiotic or antifungal use within 7 days before surgery
- Unable to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 day (day of surgery)
Participants receive a single preoperative dose of methylprednisolone or no steroid before undergoing major liver surgery.
1 preoperative visit and surgery day
Duration - 30 days
Participants are monitored for 30 days after surgery to assess recovery and any complications.
Approximately 3 to 4 follow-up visits
Trial Site Locations
Total: 19 locations
1
Rush University Medical Center (Data collection only)
Chicago, Illinois, United States, 606012
Not Yet Recruiting
2
University of Chicago (Data Collection Only)
Chicago, Illinois, United States, 60637
Not Yet Recruiting
3
Indiana University (Data Collection Only)
Indianapolis, Indiana, United States, 46202
Not Yet Recruiting
4
UNIVERSITY OF IOWA (Data Collection Only)
Iowa City, Iowa, United States, 52242
Not Yet Recruiting
5
University of Kentucky (Data Collection Only)
Lexington, Kentucky, United States, 40536-0093
Not Yet Recruiting
6
Henry Ford Hospital (Data collection only)
Detroit, Michigan, United States, 48202
Not Yet Recruiting
7
Mayo Clinic (Data Collection Only)
Rochester, Minnesota, United States, 55905
Not Yet Recruiting
8
Washington University (Data Collection Only)
St Louis, Missouri, United States, 63110
Not Yet Recruiting
9
University of Nebraska Medical Center (Data Collection Only)
Omaha, Nebraska, United States, 68198-7680
Not Yet Recruiting
10
Rutgers University (Data Collection Only)
New Brunswick, New Jersey, United States, 08903
Not Yet Recruiting
11
Memorial Sloan Kettering Commack (Data Collection Only)
Commack, New York, United States, 11725
Actively Recruiting
12
Memoral Sloan Kettering Westchester (Data Collection Only)
Harrison, New York, United States, 10604
Actively Recruiting
13
Northwell Health (Data collection only)
Manhasset, New York, United States, 11030
Not Yet Recruiting
14
New York University (Data Collection Only)
New York, New York, United States, 10010
Not Yet Recruiting
15
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
16
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
Not Yet Recruiting
17
Duke University (Data Collection Only)
Durham, North Carolina, United States, 27710
Not Yet Recruiting
18
Gundersen Lutheran Medical Foundation (Data Collection Only)
La Crosse, Wisconsin, United States, 54601
Not Yet Recruiting
19
University of Wisconsin (Data Collection Only)
Madison, Wisconsin, United States, 53792
Not Yet Recruiting
Research Team
M
Michael D'Angelica, MD
P
Peter Kingham, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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