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

NCT01526200 | Completed

• 1 other identifier: CEIOUSCLM
• Study Type: observational
• Target: 127
• Locations: 1 country
• Sites: 1

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.

Conditions

Colon Cancer Liver Metastasis

Keywords

CLM

Outcome Measures

Primary Outcomes (1)

• new colorectal liver metastases detected at contrast-enhanced intraoperative ultrasonography

  October 2007 - March 2011 (up to 4 years)

Secondary Outcomes (2)

• new colorectal liver metastases detected at intraoperative ultrasonography

  October 2007 - March 2011 (up to 4 years)

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

  October 2007 - December 2011 (up to 4 years)

Study Arms (1)

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.

Procedure: Contrast-enhanced intraoperative ultrasound

Interventions

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.

Also known as: Sonovue, Sonazoid, CEIOUS

CEIOUS

Eligibility Criteria

• Age: 29 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutively enrolled patients with CLM who underwent surgery and during this procedure received IOUS and CE-IOUS.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Milan: lead

Study Sites (1)

Istituto Clinico Humanitas IRCS

Rozzano, Milan, 20089, Italy

Location

MeSH Terms

Interventions

contrast agent BR1; Sonazoid

Study Officials

• Guido Torzilli, MD, PhD

  University of Milano

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery, MD, PhD

Study Record Dates

• First Submitted: January 27, 2012
• First Posted: February 3, 2012
• Study Start: October 1, 2007
• Primary Completion: March 1, 2011
• Study Completion: December 1, 2011
• Last Updated: February 3, 2012

Record last verified: 2012-01

Locations

IT (1)