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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

127 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-10-31

Study Completion Date

2011-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Colon Cancer Liver Metastasis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Contrast-enhanced intraoperative ultrasound

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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Sonovue, Sonazoid, CEIOUS

Eligibility Criteria

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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

Minimum Eligible Age

29 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No