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

Colon Cancer Liver Metastasis Clinical Trial

— CEIOUSCLM  

Official title:

Factors Influencing the Impact of Contrast-Enhanced Intraoperative Ultrasound During Liver Surgery for Colorectal Cancer Liver Metastases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01526200
• Other study ID #: CEIOUSCLM
• Status: Completed
• Phase: N/A
• First received: January 27, 2012
• Last updated: February 2, 2012
• Start date: October 2007
• Est. completion date: December 2011

Study information

• Verified date: January 2012
• Source: University of Milan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: December 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 29 Years to 85 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Colon Cancer Liver Metastasis
• Colorectal Neoplasms
• Liver Neoplasms
• Neoplasm Metastasis

Intervention

Procedure:
• Contrast-enhanced intraoperative ultrasound
After entering the abdominal cavity, liver mobilization is achieved by dissecting the round and falciform ligaments. IOUS is carried out with a standard 3-6 MHz convex probe, and a 7.5-10 MHz micro convex probe. Staging was 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.

Locations

Country	Name	City	State
Italy	Istituto Clinico Humanitas IRCS	Rozzano	Milan

Sponsors (1)

Lead Sponsor	Collaborator
University of Milan

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	new colorectal liver metastases detected at contrast-enhanced intraoperative ultrasonography		October 2007 - March 2011 (up to 4 years)	Yes
Secondary	new colorectal liver metastases detected at intraoperative ultrasonography		October 2007 - March 2011 (up to 4 years)	Yes
Secondary	new colorectal liver metastases detected during 6-month postoperative follow-up		October 2007 - December 2011 (up to 4 years)	Yes