Institut Bergonié
Bordeaux, Aquitaine, 33000, France
NCT Number: NCT01880554
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).
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Bordeaux, Aquitaine, 33000, France
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Once the patient is included in the study, a staging procedure is performed in three stages before hepatic metastases treatment:
Step # 1 preoperative (maximum 8 weeks before surgery Steps # 2 and # 3 intraoperative performed by the same surgeon in 2 stages
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:
Time frame: at time of surgery
The primary endpoint will be assessed in the subgroup of patients who received preoperative chemotherapy. As for the primary outcome, the clinical utility is evaluated in terms of justified modification of the surgical gesture envisaged following CE-IOUS, compared to the surgical gesture envisaged following a conventional intraoperative ultrasound.
We reported the percentage of patients for whom there was a modified and justified surgical gesture following CE-IOUS in the subgroup of patients who received preoperative chemotherapy.
Time frame: up to 3 months after surgery
Detection of malignant lesions by CE-IOUS in chemotherapy-free patients within 3 post-operative months. The detection rate is defined as the proportion of malignant lesions for which there is concordance between the diagnosis established by CE-IOUS and the reference examination.
Time frame: At time of contrast-enhanced IOUS
Description of technical arrangements for the CE-IOUS duration. The length of time during which contrast injection was useable.
Time frame: up to 3 months after surgery
Characterisation rate for focal liver lesions: the proportion of lesions whose nature on CE-IOUS is identical to the nature of the lesions defined by the reference examinations among all the lesions seen on CE-IOUS (malignant and benign)
Institut Bergonié
Other
Clinical Utility of Contrast-enhanced Intraoperative Ultrasound in Surgery of Colorectal Liver Metastases. Phase II Clinical Trial.
Acronym: ULIIS
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