Anatomical Resection of the Liver for Hepatocellular Carcinoma: a New Ultrasound Guided Approach - Full Text View

Sponsored by:	University of Milan
Information provided by:	University of Milan
ClinicalTrials.gov Identifier:	NCT00829335

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:	Cohort, Prospective
Official Title:	Anatomical Segmental and Subsegmental Resection of the Liver for Hepatocellular Carcinoma: a New Approach by Means of Ultrasound-Guided Vessel Compression

Resource links provided by NLM:

MedlinePlus related topics: Anatomy Ultrasound

U.S. FDA Resources

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

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.

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00829335

Locations

Italy, MILANO
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.

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. No abstract available.

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.

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

Keywords provided by University of Milan:

Intraoperative ultrasound
Segmentectomy
HCC

Study placed in the following topic categories:

Liver Neoplasms
Liver Diseases
Digestive System Diseases
Digestive System Neoplasms
Carcinoma, Hepatocellular

Gastrointestinal Neoplasms
Hepatocellular Carcinoma
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Liver Neoplasms
Liver Diseases
Neoplasms
Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms

Neoplasms by Histologic Type
Carcinoma, Hepatocellular
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on September 10, 2009