- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00797251
Anatomical Right Posterior Sectionectomy of the Liver by IOUS-Guided Finger Compression
November 24, 2008 updated by: University of Milan
A Novel Simple Technique for Performing Anatomical Right Posterior Sectionectomy of the Liver: the Ultrasound-Guided Finger Compression
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.
Study Overview
Status
Unknown
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Anticipated)
10
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Milan
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Rozzano, Milan, Italy, 20089
- University of Milan School of Medicine, IRCCS Istituto Clinico Humanitas
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Right posterior section group
Patients with tumors in the right posterior section of the liver (segments 6-7)
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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The primary outcome is the safety of the anatomical right posterior sectionectomy performed IOUS-guided finger compression.
Time Frame: 6 months
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6 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The secondary outcome is the efficacy of the anatomical right posterior sectionectomy performed by IOUS-guided finger compression.
Time Frame: 1 year
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1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Guido Torzilli, MD, PhD, University of Milan School of Medicine, IRCCS Istituto Clinico Humanitas
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- Torzilli G, Donadon M, Montorsi M. The surgical margin in liver resection for hepatocellular carcinoma: a real problem or not? Ann Surg. 2007 Oct;246(4):690-1; author reply 691-2. doi: 10.1097/SLA.0b013e318156e286. No abstract available.
- 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. doi: 10.1002/bjs.5321.
- 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. doi: 10.1016/j.jamcollsurg.2005.04.026.
- Torzilli G, Makuuchi M. Ultrasound-guided finger compression in liver subsegmentectomy for hepatocellular carcinoma. Surg Endosc. 2004 Jan;18(1):136-9. doi: 10.1007/s00464-003-9024-x. Epub 2003 Nov 21.
- Takasaki K, Kobayashi S, Tanaka S, Saito A, Yamamoto M, Hanyu F. Highly anatomically systematized hepatic resection with Glissonean sheath code transection at the hepatic hilus. Int Surg. 1990 Apr-Jun;75(2):73-7.
- Launois B, Jamieson GG. The posterior intrahepatic approach for hepatectomy or removal of segments of the liver. Surg Gynecol Obstet. 1992 Feb;174(2):155-8.
- Makuuchi M, Hasegawa H, Yamazaki S. Ultrasonically guided subsegmentectomy. Surg Gynecol Obstet. 1985 Oct;161(4):346-50.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2007
Primary Completion (ANTICIPATED)
January 1, 2009
Study Completion (ANTICIPATED)
January 1, 2009
Study Registration Dates
First Submitted
November 24, 2008
First Submitted That Met QC Criteria
November 24, 2008
First Posted (ESTIMATE)
November 25, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
November 25, 2008
Last Update Submitted That Met QC Criteria
November 24, 2008
Last Verified
November 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IOUS-Compression
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