Alternative Surgical Policy for Central Liver Tumors

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. Identifier: NCT00600522
Recruitment Status : Completed
First Posted : January 25, 2008
Last Update Posted : January 25, 2008
Information provided by:
University of Milan

Brief Summary:
Major hepatectomies have not negligible morbidity and mortality. However, when tumors invade middle hepatic vein (MHV) at caval confluence major surgery is usually recommended. Ultrasound-guided hepatectomy might allow conservative approaches. We prospectively check its feasibility in a series of patients carriers of tumors invading the MHV at the caval confluence.

Condition or disease Intervention/treatment
Colorectal Liver Metastases Hepatocellular Carcinoma Procedure: Ultrasound-guided hepatectomy

Detailed Description:
Major hepatectomies have not negligible morbidity and mortality. However, when tumors invade middle hepatic vein (MHV) at caval confluence trisectionectomy (TS) is generally performed, and central hepatectomy or mesohepatectomy (MH) (Segments 4, 5 and 8), is considered by some authors to be the conservative alternative to the previously cited approach. Between these two surgical interventions there is not, up to now, any evidence that one of them should be clearly preferred; anyway both are mojor resections. We previously reported that a surgical approach based on ultrasound-guided hepatectomy might minimize the need for major resection, whose rates of morbidity and mortality are not negligible. This policy could be useful also for disclosing new, more conservative, and better tolerated approaches for tumors invading the MHV at caval confluence in alternative to MH and TS. This study analyses the feasibility, safety and effectiveness of ultrasound-guided resections applied to these patients enrolled prospectively from a cohort of consecutive patients who undergo hepatectomy for tumors.

Study Type : Observational
Actual Enrollment : 15 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ultrasound-Guided Conservative Heopatecomy for Tumors Invading the Middle Hepatic Vein at the Caval Confluence as Alternative to Mesohepatectomy and Trisectionectomy
Study Start Date : January 2004
Actual Primary Completion Date : January 2007
Actual Study Completion Date : May 2007

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MedlinePlus related topics: Ultrasound
U.S. FDA Resources

Group/Cohort Intervention/treatment
Patients selected for hepatectomy because carriers of hepatocellular carcinoma or colorectal cancer liver metastases invading the middle hepatic vein at caval confluence (last 4 cm).
Procedure: Ultrasound-guided hepatectomy

After laparotomy and staging by intraoperative ultrasound (IOUS), anterior surface of the hepatocaval confluence is exposed. Than, compression by means of the surgeon's finger-tip is applied at the MHV caval confluence verifying at color-Doppler IOUS the disappearance of the blood flow in the MHV or its inversion. Then, MHV clamping itself is carried out, and parenchymal sparing resection would be selected if at least one of these 3 findings is confirmed:

  1. Reversal color-Doppler IOUS flow direction in the peripheral portion of the MHV, which suggests the drainage through collateral circulation in the RHV/LHV depending on the side of the MHV branch with reversal flow.
  2. Detectable shunting collaterals at color-Doppler IOUS with RHV or LHV.
  3. Hepatopetal flow in P5-8 and/or P4inf portal branches. If none of these finding is confirmed and in particular hepatofugal flow direction in the P5-8 and/or P4 inf is detected the hepatectomy has to be extended.

Primary Outcome Measures :
  1. The primary outcome measure was the rate of failure of conservative resection, i.e. the rate of patients who received TSs or MHs despite they fitted in the eligibility criteria. [ Time Frame: January 2007 ]

Secondary Outcome Measures :
  1. The secondary outcome measure was the safety of the procedure. For that, we studied morbidity, mortality, amount of blood loss, rate of blood transfusions, and postoperative trend of liver function tests. [ Time Frame: January 2007 ]

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients carriers of hepatocellular carcinoma or colorectal cancer liver metastases addressed to surgical resection

Inclusion Criteria:

  • Patients carriers of HCC or colorectal cancer liver metastases (CLM) who have macroscopic signs of vascular invasion (preoperative imaging and/IOUS) of the MHV close to the hepato-caval confluence (within 4 cm) demanding for that MHV resection.

Minimum follow-up for patients' inclusion was established at 6-months from surgery.

Exclusion Criteria:

  • Patients carriers of tumors occupying entirely the right paramedian section and the segment 4, for whom at least a MH would have been compulsorily carried out.

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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 identifier (NCT number): NCT00600522

Istituto Clinico Humanitas, IRCCS
Rozzano, Milano, Italy, 20089
Sponsors and Collaborators
University of Milan
Principal Investigator: Guido Torzilli, MD, PhD University of Milan, Istituto Clinico Humanitas - IRCCS

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Prof. Guido Torzilli, University of Milan - Istituto Clinico Humanitas, IRCCS Identifier: NCT00600522     History of Changes
Other Study ID Numbers: HEP-MHV
First Posted: January 25, 2008    Key Record Dates
Last Update Posted: January 25, 2008
Last Verified: January 2008

Keywords provided by University of Milan:
intraoperative ultrasonography
colorectal liver metastases
hepatocellular carcinoma
contrast enhanced intraoperative ultrasonography.

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