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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00829335
First Posted: January 27, 2009
Last Update Posted: January 27, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Milan
  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

Secondary Outcome Measures:
  • Morbidity and mortality [ Time Frame: 30 and 90 days ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Torzilli G, Donadon M, Marconi M, Palmisano A, Del Fabbro D, Spinelli A, Botea F, Montorsi M. Hepatectomy for stage B and stage C hepatocellular carcinoma in the Barcelona Clinic Liver Cancer classification: results of a prospective analysis. Arch Surg. 2008 Nov;143(11):1082-90. doi: 10.1001/archsurg.143.11.1082.
Torzilli G, Palmisano A, Del Fabbro D, Marconi M, Donadon M, Spinelli A, Bianchi PP, Montorsi M. Contrast-enhanced intraoperative ultrasonography during surgery for hepatocellular carcinoma in liver cirrhosis: is it useful or useless? A prospective cohort study of our experience. Ann Surg Oncol. 2007 Apr;14(4):1347-55. Epub 2007 Jan 26.
Torzilli G, Makuuchi M. Ultrasound-guided finger compression in liver subsegmentectomy for hepatocellular carcinoma. Surg Endosc. 2004 Jan;18(1):136-9. Epub 2003 Nov 21.
Torzilli G, Makuuchi M. Ultrasound-guided liver subsegmentectomy: the peculiarity of segment 4. J Am Coll Surg. 2001 Dec;193(6):706-8.
Torzilli G, Takayama T, Hui AM, Kubota K, Harihara Y, Makuuchi M. A new technical aspect of ultrasound-guided liver surgery. Am J Surg. 1999 Oct;178(4):341-3.
Torzilli G, Montorsi M, Gambetti A, Del Fabbro D, Donadon M, Bianchi P, Olivari N, Makuuchi M. Utility of the hooking technique for cases of major hepatectomy. Surg Endosc. 2005 Aug;19(8):1156-7. Epub 2005 May 26.
Torzilli G, Montorsi M, Del Fabbro D, Palmisano A, Donadon M, Makuuchi M. Ultrasonographically guided surgical approach to liver tumours involving the hepatic veins close to the caval confluence. Br J Surg. 2006 Oct;93(10):1238-46.
Torzilli G, Montorsi M, Donadon M, Palmisano A, Del Fabbro D, Gambetti A, Olivari N, Makuuchi M. "Radical but conservative" is the main goal for ultrasonography-guided liver resection: prospective validation of this approach. J Am Coll Surg. 2005 Oct;201(4):517-28.
Torzilli G, Donadon M, Marconi M, Botea F, Palmisano A, Del Fabbro D, Procopio F, Montorsi M. Systematic extended right posterior sectionectomy: a safe and effective alternative to right hepatectomy. Ann Surg. 2008 Apr;247(4):603-11. doi: 10.1097/SLA.0b013e31816387d7.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Submitted: January 26, 2009
First Posted: January 27, 2009
Last Update Posted: January 27, 2009
Last Verified: January 2009

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
Glucuronyl glucosamine glycan sulfate
Anticoagulants
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Hypoglycemic Agents
Physiological Effects of Drugs


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