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Contrast-enhanced intraoperative ultrasound

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

EVRARD Serge, PU-PH

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).

Ultrasound Liver Intraoperative Imaging With SonoVue®

Clinical Utility of Contrast-enhanced Intraoperative Ultrasound in Surgery of Colorectal Liver Metastases. Phase II Clinical Trial.

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.

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.

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.

Description of technical arrangements for the CE-IOUS duration. The length of time during which contrast injection was useable.

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

Contrast-enhanced intraoperative ultrasound

Contrast-enhanced intraoperative ultrasound: 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

Contrast-enhanced Intraoperative Ultrasound

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

Right Colon

Left Colon

Transverse Colon

Rectum

Cancer localization

Synchronous

Metachronous

Liver metastases

Derek Dinart

Contrast-enhanced intraoperative ultrasound

Contrast-enhanced intraoperative ultrasound: 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. Step #2 intraoperative ultrasound and step #3 Contrast-enhanced intraoperative ultrasound

We used a 2-stage Simon's design with the following assumptions:

* maximum tolerated futility rate: 5%,
* expected minimum utility rate: 15%,
* Type I error of 10%,
* power of 85%. Thus, 52 eligible and evaluable patients were required (25 in the first stage). First stage: stop, if CE-IOUS is not deemed clinically useful for at least one patient (4.0%).

Second stage: CE-IOUS clinically useful if the planned surgical procedure is modified and justified for 5 or more patients (9.6%).

Clinical Utility of Intraoperative Contrast Ultrasound in the Surgery of Colorectal Cancer Liver Metastases.

Subgroup of patients with preoperative chemotherapy

Clinical Utility of CE-IOUS in Subgroup of Patients Who Received Preoperative Chemotherapy

There were 22 (40.7%) out of 54 chemotherapy-free patients within 3 post-operative months

Spots Global Cancer Trial Database for Ultrasound Liver Intraoperative Imaging With SonoVue®

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