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Anatomical Right Posterior Sectionectomy of the Liver by IOUS-Guided Finger Compression

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by University of Milan.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Milan
ClinicalTrials.gov Identifier:
NCT00797251
First received: November 24, 2008
Last updated: NA
Last verified: November 2008
History: No changes posted
  Purpose

The use of intraoperative ultrasound (IOUS) allows us to perform new conservative hepatectomies. The investigators previously reported the systematic subsegmentectomy by IOUS-guided finger compression for segments 2-3, which is currently applied for patients with hepatocellular carcinoma (HCC)on cirrhosis. The investigators herein describe a novel technique, which consists in the systematic right posterior sectionectomy by IOUS-guided finger compression.


Condition Intervention
Colorectal Liver Metastases
Hepatocellular Carcinoma
Liver Malignancies
 Procedure: Anatomical right posterior sectionectomy of the liver by IOUS-guided finger compression.

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Novel Simple Technique for Performing Anatomical Right Posterior Sectionectomy of the Liver: the Ultrasound-Guided Finger Compression

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by University of Milan:

Primary Outcome Measures:
  • The primary outcome is the safety of the anatomical right posterior sectionectomy performed IOUS-guided finger compression. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The secondary outcome is the efficacy of the anatomical right posterior sectionectomy performed by IOUS-guided finger compression. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: September 2007
Estimated Study Completion Date: January 2009
Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Right posterior section group
Patients with tumors in the right posterior section of the liver (segments 6-7)
 Procedure: Anatomical right posterior sectionectomy of the liver by IOUS-guided finger compression.
The technique consists in IOUS-guided finger compression of the right posterior portal pedicle at the level closest to the tumor but oncologically suitable. This method allows us to anatomically mark the area of resection with nor hilar plate nor IOUS-guided puncture of vessels, which are up to date the only two techniques available to perform anatomical right posterior sectionectomy - namely the removal of segment 6 and 7.
Other Name: anatomic resection of segment 6-7

Detailed Description:

A novel technique for the demarcation of the resection area by means of IOUS-guided finger compression to accomplish a right posterior sectionectomy is described. Dissection or encirclement of the sectional pedicles for resection area demarcation is thus avoided. Ten patients underwent this technique successfully without mortality or major morbidity. IOUS-guided finger compression of sectional portal pedicle feeding the right posterior section is a feasible, safe, and effective method.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The study population include patients with primary or secondary liver tumors in the right posterior section of the liver eligible to a right posterior sectionectomy as a primary surgical procedure.

Criteria

Inclusion Criteria:

  • Patients with tumors at least at 1 cm distally to the bifurcation of the right portal vein (bifurcation of P5-8 and P6-7) eligible for right posterior sectionectomy, namely the anatomical removal of segment 6 and 7, were considered potential candidates to this procedure. Precisely, these criteria were adopted:

    • Patients with hepatocellular carcinoma (HCC) with infiltrative growing pattern in contact with P6-7;
    • Patients with any type of HCC in contact with P6-7 with distal bile duct dilation;
    • Patients with colorectal liver metastasis (CLM) in contact with P6-7.

Exclusion Criteria:

  • Exclusion criteria for carrying out the herein described procedure was considered the presence of tumoral thrombosis in P6-7.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00797251

Locations
Italy
University of Milan School of Medicine, IRCCS Istituto Clinico Humanitas
Rozzano, Milan, Italy, 20089
Sponsors and Collaborators
University of Milan
Investigators
Principal Investigator: Guido Torzilli, MD, PhD University of Milan School of Medicine, IRCCS Istituto Clinico Humanitas
  More Information

Publications:

Responsible Party: Guido Torzilli, MD, PhD, University of Milan School of Medicine
ClinicalTrials.gov Identifier: NCT00797251     History of Changes
Other Study ID Numbers: IOUS-Compression
Study First Received: November 24, 2008
Last Updated: November 24, 2008
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by University of Milan:
Colorectal liver metastasis
hepatocellular carcinoma
liver surgery
intraoperative ultrasound
finger-compression

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

ClinicalTrials.gov processed this record on May 21, 2013