Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Methylprednisolone | Experimental |
| |
| Cohort 2: No Steroid | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylprednisolone | Drug | single preoperative dose of methylprednisolone |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 days |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
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.
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael D'Angelica, MD | Contact | 212-639-3226 | dangelim@MSKCC.ORG | |
| Peter Kingham, MD | Contact | 212-639-5260 | kinghamP@mskcc.org |
| Name | Affiliation | Role |
|---|---|---|
| Michael D'Angelica, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center (Data collection only) | Not yet recruiting | Chicago | Illinois | 606012 | United States |
Not provided
| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
Not provided
• 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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| University of Chicago (Data Collection Only) | Not yet recruiting | Chicago | Illinois | 60637 | United States |
|
| Indiana University (Data Collection Only) | Not yet recruiting | Indianapolis | Indiana | 46202 | United States |
|
| UNIVERSITY OF IOWA (Data Collection Only) | Not yet recruiting | Iowa City | Iowa | 52242 | United States |
|
| University of Kentucky (Data Collection Only) | Not yet recruiting | Lexington | Kentucky | 40536-0093 | United States |
|
| Henry Ford Hospital (Data collection only) | Not yet recruiting | Detroit | Michigan | 48202 | United States |
|
| Mayo Clinic (Data Collection Only) | Not yet recruiting | Rochester | Minnesota | 55905 | United States |
|
| Washington University (Data Collection Only) | Not yet recruiting | St Louis | Missouri | 63110 | United States |
|
| University of Nebraska Medical Center (Data Collection Only) | Not yet recruiting | Omaha | Nebraska | 68198-7680 | United States |
|
| Rutgers University (Data Collection Only) | Not yet recruiting | New Brunswick | New Jersey | 08903 | United States |
|
| Memorial Sloan Kettering Commack (Data Collection Only) | Recruiting | Commack | New York | 11725 | United States |
|
| Memoral Sloan Kettering Westchester (Data Collection Only) | Recruiting | Harrison | New York | 10604 | United States |
|
| Northwell Health (Data collection only) | Not yet recruiting | Manhasset | New York | 11030 | United States |
|
| New York University (Data Collection Only) | Not yet recruiting | New York | New York | 10010 | United States |
|
| Memorial Sloan Kettering Cancer Center (All Protocol Activities) | Recruiting | New York | New York | 10065 | United States |
|
| SUNY Upstate Medical University | Not yet recruiting | Syracuse | New York | 13210 | United States |
|
| Duke University (Data Collection Only) | Not yet recruiting | Durham | North Carolina | 27710 | United States |
|
| Gundersen Lutheran Medical Foundation (Data Collection Only) | Not yet recruiting | La Crosse | Wisconsin | 54601 | United States |
|
| University of Wisconsin (Data Collection Only) | Not yet recruiting | Madison | Wisconsin | 53792 | United States |
|
| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided