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
- 1
- 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.
研究组 & 干预措施
Contrast-enhanced intraoperative ultrasound
Contrast-enhanced intraoperative ultrasound
干预措施: Contrast-enhanced intraoperative ultrasound (Device)
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
- Description of Technical Arrangements for the CE-IOUS(At time of contrast-enhanced IOUS)
- Performance Evaluation of Intraoperative Ultrasound Contrast: Detection Rate Per Lesion(up to 3 months after surgery)
- Performance Evaluation of Intraoperative Ultrasound Contrast Per Lesion: Characterisation Rate(up to 3 months after surgery)
- Clinical Utility of CE-IOUS in Subgroup of Patients Who Received Preoperative Chemotherapy(at time of surgery)