Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Purpose

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.


Condition Intervention
Colon Cancer Liver Metastasis
Procedure: Contrast-enhanced intraoperative ultrasound

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Factors Influencing the Impact of Contrast-Enhanced Intraoperative Ultrasound During Liver Surgery for Colorectal Cancer Liver Metastases

Resource links provided by NLM:


Further study details as provided by University of Milan:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 127
Study Start Date: October 2007
Study Completion Date: December 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   29 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01526200

Locations
Italy
Istituto Clinico Humanitas IRCS
Rozzano, Milan, Italy, 20089
Sponsors and Collaborators
University of Milan
Investigators
Principal Investigator: Guido Torzilli, MD, PhD University of Milano
  More Information

No publications provided

Responsible Party: Prof. Guido Torzilli, Professor of Surgery, MD, PhD, University of Milan
ClinicalTrials.gov Identifier: NCT01526200     History of Changes
Other Study ID Numbers: CEIOUSCLM
Study First Received: January 27, 2012
Last Updated: February 2, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by University of Milan:
CLM

Additional relevant MeSH terms:
Colorectal Neoplasms
Liver Neoplasms
Neoplasm Metastasis
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Liver Diseases
Neoplasms
Neoplasms by Site
Neoplastic Processes
Pathologic Processes
Rectal Diseases

ClinicalTrials.gov processed this record on November 20, 2014