Contrast-Enhanced Intraoperative Ultrasound During Liver Surgery for Colorectal Cancer Liver Metastases (CEIOUSCLM)

University of Milan

Status: Completed

Conditions: Colon Cancer Liver Metastasis

Treatments: Procedure: Contrast-enhanced intraoperative ultrasound

Study type: Observational

Funder types: Other

Identifiers

NCT01526200

CEIOUSCLM

Details and patient eligibility

About

Contrast-enhanced intraoperative ultrasound (CE-IOUS) during surgery for colorectal liver metastases (CLM) has become a part of clinical practice. However, if it should be selectively or routinely applied remains unclear. This study is carried out to clarify which are the criteria for a selective use of CE-IOUS if any.

Full description

Contrast-enhanced intraoperative ultrasound (CE-IOUS) during surgery for colorectal liver metastases (CLM) is entered in clinical practice. However, its impact seems to decrease with the improvement of preoperative imaging. Therefore, if CE-IOUS should be selectively or routinely applied remains unclear: a profile of patients who may benefit of CE-IOUS application has to be disclosed. The aim of this study is to define reliable criteria for a selective use of CE-IOUS during surgery for CLM. IOUS is performed using 3-6 MHz convex probe, and a 7.5-10 MHz micro convex probe. Staging is completed by CE-IOUS using the standard 3-6 MHz convex probe and the dedicated 1.88-3.76 MHz harmonic frequency probe. In all patients, 2.4 mL of sulphur-hexafluoride microbubbles (SonoVue®, Bracco, Milan, Italy) are injected through a peripheral vein by the anesthesiologist. Ultrasound guidance is used to drive the dissection plane as previously described. Reference standards are histology and imaging at 6 months after surgery. Univariate and multivariate analyses are performed. Statistical significance is set at P=0.05.

Enrollment: 127 patients

Sex: All

Ages: 29 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• consecutively enrolled patients with CLM who underwent surgery and during this procedure received IOUS and CE-IOUS.
• each patient had at least 6 months of postoperative follow-up.

Exclusion criteria

• patients who after IOUS and CE-IOUS had explorative laparotomy only were excluded from the analysis since there was no histological confirmation of the tumor and most of them were lost to surgical follow-up

Trial design

127 participants in 1 patient group

CEIOUS

Description:

One hundred and twenty-seven consecutive patients -77 males and 50 females, mean age of patients was 61 years (median 65 years; range 29-85 years)- underwent liver resection using intraoperative ultrasound and contrast-enhanced intraoperative ultrasound.

Treatment:

Procedure: Contrast-enhanced intraoperative ultrasound