A Study of Methylprednisolone in People Having Liver Surgery
ConditionHepatectomy
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Methylprednisolone
Drugsingle preoperative dose of methylprednisolone
Treatment groups
750 Participants
are divided into 2 treatment groupsGroup A: Cohort 1: MethylprednisoloneExperimental treatment 1 intervention
Group B: Cohort 2: No SteroidNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
30 daysSponsors and contacts
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Source ClinicalTrials.gov