Clinical trial NCT01526200: Contrast-Enhanced Intraoperative Ultrasound During Liver Surgery for Colorectal Cancer Liver Metastases
Official title: Factors Influencing the Impact of Contrast-Enhanced Intraoperative Ultrasound During Liver Surgery for Colorectal Cancer Liver Metastases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colon Cancer Liver Metastasis
Keywords: CLM
Lead sponsor: University of Milan
Sponsor class: OTHER
First posted: 2012-02-03
Enrollment: 127
Sex: ALL
Minimum age (years): 29
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutively enrolled patients with CLM who underwent surgery and during this procedure received IOUS and CE-IOUS.

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.

Eligibility criteria: 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

Primary outcomes:
measure: new colorectal liver metastases detected at contrast-enhanced intraoperative ultrasonography
timeFrame: October 2007 - March 2011 (up to 4 years)
Secondary outcomes:
measure: new colorectal liver metastases detected at intraoperative ultrasonography
timeFrame: October 2007 - March 2011 (up to 4 years)
measure: new colorectal liver metastases detected during 6-month postoperative follow-up
timeFrame: October 2007 - December 2011 (up to 4 years)
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas IRCS
state: Milan
Study officials:
affiliation: University of Milano
name: Guido Torzilli, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: