Clinical Utility of Contrast-enhanced Intraoperative Ultrasound in Surgery of Colorectal Liver Metastases. Phase II Clinical Trial.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Liver Metastases From Colorectal Primary Cancer
- Sponsor
- Institut Bergonié
- Enrollment
- 68
- Locations
- 1
- Primary Endpoint
- Clinical Utility of Intraoperative Contrast Ultrasound in the Surgery of Colorectal Cancer Liver Metastases.
- Status
- Completed
- Last Updated
- 8 months ago
Overview
Brief Summary
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).
Detailed Description
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Clinical Utility of Intraoperative Contrast Ultrasound in the Surgery of Colorectal Cancer Liver Metastases.
Time Frame: 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.
Secondary Outcomes
- 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)