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Completed

NCT Number: NCT01526200

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.

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Key information

Age range

29 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istituto Clinico Humanitas IRCS

Rozzano, Milan, 20089, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Contrast-enhanced intraoperative ultrasound

Procedure

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 names: Sonovue, Sonazoid, CEIOUS

Primary outcomes

  1. new colorectal liver metastases detected at contrast-enhanced intraoperative ultrasonography

    Time frame: October 2007 - March 2011 (up to 4 years)

Secondary outcomes

  1. new colorectal liver metastases detected at intraoperative ultrasonography

    Time frame: October 2007 - March 2011 (up to 4 years)

  2. new colorectal liver metastases detected during 6-month postoperative follow-up

    Time frame: October 2007 - December 2011 (up to 4 years)

Sponsors and collaborators

Lead sponsor

University of Milan

Other

Registry information

Official study title

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

Acronym: CEIOUSCLM

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Feb 3, 2012
Registry last updated
Feb 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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