Clinical Utility of Contrast-enhanced Intraoperative Ultrasound in Surgery of Colorectal Liver Metastases. Phase II Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Clinical Utility of Intraoperative Contrast Ultrasound in the Surgery of Colorectal Cancer Liver Metastases.
研究概览
简要总结
Hypothesis: Use of contrast ultrasound showed interesting results, which can increase ultrasonography sensitivity performed during surgery in the evaluation of operable liver metastases.
This study is a two-stage phase II multicenter study (Simon's two-stage).
详细描述
Hypothesis
Use of contrast ultrasound showed interesting results, which can increase ultrasonography sensitivity performed during surgery in the evaluation of operable liver metastases.
This study is a two-stage phase II multicenter study (Simon's two-stage).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Patient with histological proven colorectal cancer.
- •Operable liver metastases according to preoperative imagery. Operability is the possibility of treatment by resection and/or local destruction (radiofrequency, cryotherapy…).
- •Patient treated or not with preoperative chemotherapy.
- •With or without extra-hepatic metastases
- •Age ≥ 18 years.
- •Radiological assessment by CT and MRI liver and positron emission tomography scan (PETscan) within six weeks before surgery.
- •Patient affiliated to the Social Security system.
- •Signed informed consent.
排除标准
- •Known hypersensitivity to sulfur hexafluoride or another component of SonoVue®.
- •Patients with recent acute coronary syndrome or suffering from unstable ischemic heart disease, especially: evolving myocardial infarction, unstable angina during the last 7 days, recent coronary intervention or another factor suggesting clinical instability, acute heart failure, class III or IV heart failure, severe arrhythmias.
- •Patients with right-to-left shunt, severe pulmonary arterial hypertension, uncontrolled systemic hypertension, as patients suffering from respiratory distress syndrome.
- •Pregnant and lactating women.
- •Patients with contraindication for a CT scan, a MRI or a positron emission tomography (PET) with contrast.
- •Patients with indication of two step liver surgery.
- •Patients already included in the study.
- •Patient who couldn't be treated or followed up according to study criteria for psychological, social, family or geographical reasons. Patient deprived of liberty or under guardianship.
结局指标
主要结局
Clinical Utility of Intraoperative Contrast Ultrasound in the Surgery of Colorectal Cancer Liver Metastases.
时间窗: At time of surgery
The clinical utility will be evaluated in terms of justified modification of the surgical procedure following contrast-enhanced intra-operative ultrasound (CE-IOUS), compared to the surgical procedure following conventional intra-operative ultrasound. For each patient, we will consider CE-IOUS to be clinically useful: * if the surgical procedure envisaged at the end of the CE-IOUS is different from the surgical procedure envisaged at the end of the conventional ultrasound * and if the surgical procedure envisaged at the end of the CE-IOUS is justified We reported the percentage of patients for whom there was a modified and justified surgical gesture following CE-IOUS.
次要结局
- Clinical Utility of CE-IOUS in Subgroup of Patients Who Received Preoperative Chemotherapy(at time of surgery)
- Performance Evaluation of Intraoperative Ultrasound Contrast: Detection Rate Per Lesion(up to 3 months after surgery)
- Description of Technical Arrangements for the CE-IOUS(At time of contrast-enhanced IOUS)
- Performance Evaluation of Intraoperative Ultrasound Contrast Per Lesion: Characterisation Rate(up to 3 months after surgery)