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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof. Guido Torzilli, University of Milan
ClinicalTrials.gov Identifier:
NCT01526200
First received: January 27, 2012
Last updated: February 2, 2012
Last verified: January 2012
History of Changes

January 27, 2012
February 2, 2012
October 2007
March 2011   (final data collection date for primary outcome measure)
new colorectal liver metastases detected at contrast-enhanced intraoperative ultrasonography [ Time Frame: October 2007 - March 2011 (up to 4 years) ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01526200 on ClinicalTrials.gov Archive Site
  • new colorectal liver metastases detected at intraoperative ultrasonography [ Time Frame: October 2007 - March 2011 (up to 4 years) ] [ Designated as safety issue: Yes ]
  • new colorectal liver metastases detected during 6-month postoperative follow-up [ Time Frame: October 2007 - December 2011 (up to 4 years) ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Contrast-Enhanced Intraoperative Ultrasound During Liver Surgery for Colorectal Cancer Liver Metastases
Factors Influencing the Impact of Contrast-Enhanced Intraoperative Ultrasound During Liver Surgery for Colorectal Cancer Liver Metastases

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.

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.
Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

Consecutively enrolled patients with CLM who underwent surgery and during this procedure received IOUS and CE-IOUS.
Colon Cancer Liver Metastasis
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.
Other Name: Sonovue, Sonazoid, CEIOUS
CEIOUS
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.
Intervention: Procedure: Contrast-enhanced intraoperative ultrasound
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
127
December 2011
March 2011   (final data collection date for primary outcome measure)

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
Both
29 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01526200
CEIOUSCLM
No
Prof. Guido Torzilli, University of Milan
University of Milan
Not Provided
Principal Investigator: Guido Torzilli, MD, PhD University of Milano
University of Milan
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP