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

Completed

• Conditions: Colon Cancer Liver Metastasis
• Interventions: Procedure: Contrast-enhanced intraoperative ultrasound

• Registration Number: NCT01526200
• Lead Sponsor: University of Milan

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2007-10
• Primary Completion: 2011-03
• Study Completion: 2011-12
• Status Verified: 2012-01
• Study First Submitted: 2012-01-27
• Study First Submitted QC: 2012-02-02
• Last Update Submitted: 2012-02-02
• Study First Posted: 2012-02-03
• Last Update Posted: 2012-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 127

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CEIOUS	Contrast-enhanced intraoperative ultrasound	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.

Primary Outcome Measures

Name	Time	Method
new colorectal liver metastases detected at contrast-enhanced intraoperative ultrasonography	October 2007 - March 2011 (up to 4 years)

Secondary Outcome Measures

Name	Time	Method
new colorectal liver metastases detected at intraoperative ultrasonography	October 2007 - March 2011 (up to 4 years)
new colorectal liver metastases detected during 6-month postoperative follow-up	October 2007 - December 2011 (up to 4 years)

Trial Locations

Locations (1)

Istituto Clinico Humanitas IRCS; 🇮🇹 Rozzano, Milan, Italy