HepatectomyPhase 3NCT07507643
A Study of Methylprednisolone in People Having Liver Surgery
A Phase 3 study testing Methylprednisolone in people with Hepatectomy, run by Memorial Sloan Kettering Cancer Center at 19 sites in United States.
Trial summary
The purpose of this study is to test whether receiving methylprednisolone before surgery will reduce the side effects of having surgery, such as infections and longer hospital stays. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatectomy
- What is being tested?
- Methylprednisolone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 19 sitesUnited States
- Study dates
- 27 Mar 2026to 27 Mar 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years at the time of consent.
- Scheduled to undergo elective major hepatectomy (defined by CPT codes 47122 [trisegmentectomy], 47125 [total left hepatectomy], or 47130 [total right hepatectomy]).
- In addition to major hepatectomy, as defined above, patients may undergo additional partial hepatectomy or operative ablation.
Who cannot join
- Known or documented adverse reactions to methylprednisolone.
- Unable to receive methylprednisolone because of coexisting medical conditions.
- Long-term (≥10-day course) systemic corticosteroid use, regardless of dose, if doses have been administered within 30 days of the planned date of surgery. This will not apply to steroids administered, in accordance with the standard of care, with preoperative chemotherapy. The following uses of corticosteroids are permitted: single doses, topical applications (e.g., for rash), inhaled sprays (e.g., for obstructive-airway diseases), eye drops, and local injections (e.g., intra-articular).
- Significant chance (based on surgeon judgement) of being unable to successfully complete surgery because of unresectability.
- Expected or highly likely to undergo concomitant major organ resection (stomach, pancreas, colon, rectum, uterus, ovaries, bladder, kidney, small bowel).
- Expected or highly likely to undergo biliary tree reconstruction via creation of a biliary-enteric anastomosis.
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- Scheduled to undergo concurrent insertion of a hepatic artery infusion pump device.
- Estimated renal dysfunction defined by any of the following: creatinine clearance
- ≤40 mL/min as calculated by the Cockcroft-Gault Equation, currently on hemodialysis, currently on peritoneal dialysis.
- Dependence on mechanical ventilation before surgery.
- Pregnant or nursing (lactating), where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
- Known at the time of enrollment to have a bacterial infection that is expected to be present at the time of surgery or receipt of systemic antibiotic or antifungal therapy within 7 days before surgery.
- Unable to provide informed consent
Trial locations and contacts
19 sites in 1 country. Contact the study team or a site near you to ask about taking part.
19 sites in 1 country
United States19 sites, 19 recruiting
- Not yet recruiting
Rush University Medical Center (Data collection only)
Chicago, Illinois, 606012
Matt Dixon, MD, 312-738-3732
- Not yet recruiting
University of Chicago (Data Collection Only)
Chicago, Illinois, 60637
Ryan Merkow, MD, 773-702-1470
- Recruiting
Memorial Sloan Kettering Commack (Data Collection Only)
Commack, New York, 11725
Michael D'Angelica, MD, 212-639-3226
- Not yet recruiting
Henry Ford Hospital (Data collection only)
Detroit, Michigan, 48202
Jessica DeRosier, MD, 517-205-1594
- Not yet recruiting
Duke University (Data Collection Only)
Durham, North Carolina, 27710
Michael Lidsky, MD, 919-613-1474
- Recruiting
Memoral Sloan Kettering Westchester (Data Collection Only)
Harrison, New York, 10604
Michael D'Angelica, MD, 212-639-3226
- Not yet recruiting
Indiana University (Data Collection Only)
Indianapolis, Indiana, 46202
Ryan Ellis, MD, 317-944-0920
- Not yet recruiting
UNIVERSITY OF IOWA (Data Collection Only)
Iowa City, Iowa, 52242
Carlos Chan, MD, 319-356-1727
- Not yet recruiting
Gundersen Lutheran Medical Foundation (Data Collection Only)
La Crosse, Wisconsin, 54601
Travis Smith, MD, 608-775-2331
- Not yet recruiting
University of Kentucky (Data Collection Only)
Lexington, Kentucky, 40536-0093
Michael Cavnar, PhD, 859-257-9612
- Not yet recruiting
University of Wisconsin (Data Collection Only)
Madison, Wisconsin, 53792
Daniel Abbott, MD, 608-263-0786
- Not yet recruiting
Northwell Health (Data collection only)
Manhasset, New York, 11030
Sepideh Gholami, MD, 516-734-8973
- Not yet recruiting
Rutgers University (Data Collection Only)
New Brunswick, New Jersey, 08903
Miral Grandhi, MD, 732-235-6780
- Not yet recruiting
New York University (Data Collection Only)
New York, New York, 10010
Brian Kaplan, MD, 646-501-4848
- Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Michael D'Angelica, MD, 212-639-3226
- Not yet recruiting
University of Nebraska Medical Center (Data Collection Only)
Omaha, Nebraska, 68198-7680
Bradley Reames, MD, 402-559-5600
- Not yet recruiting
Mayo Clinic (Data Collection Only)
Rochester, Minnesota, 55905
Cornelius Thiels, MD, 507-284-2511
- Not yet recruiting
Washington University (Data Collection Only)
St Louis, Missouri, 63110
Dominic Sanford, MD, 314-362-2538
- Not yet recruiting
SUNY Upstate Medical University
Syracuse, New York, 13210
Emily Allen, 315-464-5540
About this study
Official title: A Randomized Controlled Trial of Methylprednisolone Versus Standard of Care in Patients Undergoing Major Hepatectomy
The purpose of this study is to test whether receiving methylprednisolone before surgery will reduce the side effects of having surgery, such as infections and longer hospital stays.
- Conditions
- Hepatectomy
- Being tested
- Methylprednisolone
- Keywords
- Hepatectomy, Methylprednisolone, Memorial Sloan Kettering Cancer Center, 26-077
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single preoperative dose of methylprednisolone
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Methylprednisolone | Experimental | Not described Receives: Drug: Methylprednisolone |
| Cohort 2: No Steroid | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in 30-day all-cause morbidity between Cohort 1 and Cohort 2
To determine whether the administration of preoperative methylprednisolone will result in lower 30-day all-cause morbidity, compared with the standard of care (no methylprednisolone), in participants undergoing elective major hepatectomy for all indications.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start27 Mar 2026
- Primary completion27 Mar 2029 (estimated)
- Study completion27 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HepatectomyStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael D'Angelica, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07507643
- Sponsor's protocol ID
- 26-077
- Status last verified
- Jul 2026
- First submitted
- 27 Mar 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: • Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Methylprednisolone Versus Standard of Care in Patients Undergoing Major Hepatectomy
- ClinicalTrials.gov ID
- NCT07507643
- Acronym / sponsor ID
- 26-077
- Conditions
- Hepatectomy
- Keywords
- Hepatectomy, Methylprednisolone, Memorial Sloan Kettering Cancer Center, 26-077
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 27 Mar 2026 (actual)
- Primary completion
- 27 Mar 2029 (estimated)
- Study completion
- 27 Mar 2029 (estimated)
- First posted
- 2 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test whether receiving methylprednisolone before surgery will reduce the side effects of having surgery, such as infections and longer hospital stays.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Methylprednisolone | Experimental | Drug: Methylprednisolone |
| Cohort 2: No Steroid | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years at the time of consent.
- Scheduled to undergo elective major hepatectomy (defined by CPT codes 47122 [trisegmentectomy], 47125 [total left hepatectomy], or 47130 [total right hepatectomy]).
- In addition to major hepatectomy, as defined above, patients may undergo additional partial hepatectomy or operative ablation.
Key exclusion criteria (13 listed)
- Known or documented adverse reactions to methylprednisolone.
- Unable to receive methylprednisolone because of coexisting medical conditions.
- Long-term (≥10-day course) systemic corticosteroid use, regardless of dose, if doses have been administered within 30 days of the planned date of surgery. This will not apply to steroids administered, in accordance with the standard of care, with preoperative chemotherapy. The following uses of corticosteroids are permitted: single doses, topical applications (e.g., for rash), inhaled sprays (e.g., for obstructive-airway diseases), eye drops, and local injections (e.g., intra-articular).
- Significant chance (based on surgeon judgement) of being unable to successfully complete surgery because of unresectability.
- Expected or highly likely to undergo concomitant major organ resection (stomach, pancreas, colon, rectum, uterus, ovaries, bladder, kidney, small bowel).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methylprednisolonesingle preoperative dose of methylprednisolone | Drug | Cohort 1: Methylprednisolone |
Primary outcome
Difference in 30-day all-cause morbidity between Cohort 1 and Cohort 2
Time frame: 30 days
To determine whether the administration of preoperative methylprednisolone will result in lower 30-day all-cause morbidity, compared with the standard of care (no methylprednisolone), in participants undergoing elective major hepatectomy for all indications.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. • Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael D'Angelica, MD principal investigator
Memorial Sloan Kettering Cancer Center
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Methylprednisolone in people with Hepatectomy, run by Memorial Sloan Kettering Cancer Center at 19 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael D'Angelica, MD (212-639-3226, dangelim@MSKCC.ORG), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in 30-day all-cause morbidity between Cohort 1 and Cohort 2 (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.