NCT07507643招募中3 期
A Randomized Controlled Trial of Methylprednisolone Versus Standard of Care in Patients Undergoing Major Hepatectomy
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 750
- 试验地点
- 19
- 主要终点
- Difference in 30-day all-cause morbidity between Cohort 1 and Cohort 2
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Difference in 30-day all-cause morbidity between Cohort 1 and Cohort 2
时间窗: 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.
次要结局
未报告次要终点
研究者
研究点 (19)
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