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

Sponsor
University of Milan (Other)
Overall Status
Completed
CT.gov ID
NCT00829335
Collaborator
(none)
30
1
24
1.2

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Procedure: IOUS-GUIDED INTRAHEPATIC VESSEL COMPRESSION

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.

Study Design

Study Type:
Observational
Actual Enrollment :
30 participants
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
Study Start Date :
Jan 1, 2007
Actual Primary Completion Date :
Jan 1, 2009
Actual Study Completion Date :
Jan 1, 2009

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. Technical feasibility []

Secondary Outcome Measures

  1. Morbidity and mortality [30 and 90 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Istituto Clinico Humanitas Irccs Rozzano Milano Italy 20089

Sponsors and Collaborators

  • University of Milan

Investigators

  • Study Chair: GUIDO TORZILLI, MD, PHD, University of Milan

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00829335
Other Study ID Numbers:
  • IOUS-COMP GENERAL
First Posted:
Jan 27, 2009
Last Update Posted:
Jan 27, 2009
Last Verified:
Jan 1, 2009
Keywords provided by , ,
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 27, 2009