Anatomical Resection of the Liver for Hepatocellular Carcinoma: a New Ultrasound Guided Approach

This study has been completed.
Sponsor:
Information provided by:
University of Milan
ClinicalTrials.gov Identifier:
NCT00829335
First received: January 26, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
  Purpose

Anatomical resection is the gold standard approach for liver resection in patients with HCC. A new method for that by means of IOUS-guided finger compression has been devised.


Condition Intervention
Hepatocellular Carcinoma
Procedure: IOUS-GUIDED INTRAHEPATIC VESSEL COMPRESSION

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Anatomical Segmental and Subsegmental Resection of the Liver for Hepatocellular Carcinoma: a New Approach by Means of Ultrasound-Guided Vessel Compression

Further study details as provided by University of Milan:

Primary Outcome Measures:
  • Technical feasibility [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Morbidity and mortality [ Time Frame: 30 and 90 days ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: January 2007
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
HCC patients
According with the investigators previously reported selection flow-chart , patients suitable for surgical approach were those with HCC without ascites, without or with esophageal varices for which preoperative endoscopic eradication could be carried out successfully, and with serum bilirubin level lower than 1.5 mg/dl. Potential candidates to systematic segmental or subsegmental resection by IOUS-guided finger compression were considered patients with single HCC located in one or 2 adjacent segments without portal thrombosis, and anyway not demanding for its complete removal a sectional resection or wider.
Procedure: IOUS-GUIDED INTRAHEPATIC VESSEL COMPRESSION
Using the IOUS, the tumor and the level targeted for compression are identified. Than, under the IOUS guidance, the surgeon compresses bilaterally the liver at the targeted position resulting in the compression of the portal pedicle feeding the tumor previously identified. This maneuver is constantly monitored in real-time just using the same microconvex probe, and it is maintained until the surface of the targeted liver area begins to discolor, at that time the first assistant marks the discolored area with the electrocautery, and the compression is released. Once the area is demarcated, liver dissection is started under intermittent Pringle's maneuver.

Detailed Description:

We herein describe a novel technique for the demarcation of the resection area by means of IOUS-guided finger compression to systematically accomplish anatomical segmental and subsegmental resections.

Using the IOUS, the tumor and the level targeted for compression are identified. Than, under the IOUS guidance, the surgeon compresses bilaterally the liver at the targeted position resulting in the compression of the portal pedicle feeding the tumor previously identified. This maneuver is constantly monitored in real-time just using the same microconvex probe, and it is maintained until the surface of the targeted liver area begins to discolor, at that time the first assistant marks the discolored area with the electrocautery, and the compression is released. Once the area is demarcated, liver dissection is started under intermittent Pringle's maneuver.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients reffered to our outpatient clinic for evaluation as carriers of HCC

Criteria

Inclusion Criteria:

  • Patients suitable for surgical approach carries of HCC
  • Serum bilirubin level lower than 1.5 mg/dl

Exclusion Criteria:

  • Presence of ascites
  • Serum bilirubin level equal or higher than 1.6 mg/dl
  • Conditions (size, vascular relation, or infiltration) demanding resection larger than a segmental area
  • Tumor thrombus in portal or hepatic veins
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00829335

Locations
Italy
Istituto Clinico Humanitas Irccs
Rozzano, Milano, Italy, 20089
Sponsors and Collaborators
University of Milan
Investigators
Study Chair: GUIDO TORZILLI, MD, PHD University of Milan
  More Information

Publications:

Responsible Party: GUIDO TORZILLI, University of Milan - Istituto Clinico Humanitas IRCCS
ClinicalTrials.gov Identifier: NCT00829335     History of Changes
Other Study ID Numbers: IOUS-COMP GENERAL
Study First Received: January 26, 2009
Last Updated: January 26, 2009
Health Authority: Italy: Ministry of Health

Keywords provided by University of Milan:
Intraoperative ultrasound
Segmentectomy
HCC

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on July 26, 2014