Evaluation of Perioperative Residual Adrenal Function After Extended Multivisceral Resection for Primary Retroperitoneal Soft Tissue Sarcomas: a Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Serum Cortisol peak after low dose Synachten stimulation test.
研究概览
简要总结
Early recognition of adrenal function deficit in patients undergoing multivisceral surgery including adrenalectomy for primitive retroperitoneal sarcomas
详细描述
The extended multivisceral resection of retroperitoneum is the standard treatment for primary retroperitoneal soft tissue sarcomas. This procedure also includes the removal of the healthy adrenal gland ipsilateral to the tumor site.
The investigators think that a such extended surgical approach together with the removal of the adrenal gland may lead to a state of acute adrenal insufficiency and related hemodynamic instability.
In order to recognize this condition the investigators use a low dose ACTH test (Synacthen test) during the 1° and 10° post-operative days.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adult patients (age> 18 years)
- •Diagnosis of retroperitoneal sarcoma
- •Adrenalectomy enbloc included in multivisceral resection
- •Voluntary informed written consent
排除标准
- •Recurrent and / or metastatic disease
- •Patient chronically treated with corticosteroids
- •Primary disorders of adrenal gland
- •Basal serum cortisol values ≤ 7 µg / dL
- •Clinically significant heart disease
- •Altered TSH
结局指标
主要结局
Serum Cortisol peak after low dose Synachten stimulation test.
时间窗: 4 months after surgery (only if test positive on 10th postoperative day)
Assessment of postoperative chronic adrenal dysfunction.
次要结局
- Postoperative morbidity(30th postoperative day)
- Vasoactive inotropic score(Intraoperatively and up to 3rd postoperative day)
研究者
Marco Fiore
Principal Investigator
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano