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


N/A
29 Years
85 Years
Not Enrolling
Both
Colon Cancer Liver Metastasis

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Trial Information

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) 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.


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Retrospective

Outcome Measure:

new colorectal liver metastases detected at contrast-enhanced intraoperative ultrasonography

Outcome Time Frame:

October 2007 - March 2011 (up to 4 years)

Safety Issue:

Yes

Principal Investigator

Guido Torzilli, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Milano

Authority:

Italy: Ethics Committee

Study ID:

CEIOUSCLM

NCT ID:

NCT01526200

Start Date:

October 2007

Completion Date:

December 2011

Related Keywords:

  • Colon Cancer Liver Metastasis
  • CLM
  • Colonic Neoplasms
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Liver Neoplasms

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