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

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

January 26, 2009
January 26, 2009
January 2007
January 2009   (final data collection date for primary outcome measure)
Technical feasibility [ Designated as safety issue: No ]
Same as current
No Changes Posted
Morbidity and mortality [ Time Frame: 30 and 90 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Anatomical Resection of the Liver for Hepatocellular Carcinoma: a New Ultrasound Guided Approach
Anatomical Segmental and Subsegmental Resection of the Liver for Hepatocellular Carcinoma: a New Approach by Means of Ultrasound-Guided Vessel Compression

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

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

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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
January 2009
January 2009   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00829335
IOUS-COMP GENERAL
Yes
GUIDO TORZILLI, University of Milan - Istituto Clinico Humanitas IRCCS
University of Milan
Not Provided
Study Chair: GUIDO TORZILLI, MD, PHD University of Milan
University of Milan
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP