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Alternative Surgical Policy for Central Liver Tumors

This study has been completed.
Sponsor:
Information provided by:
University of Milan
ClinicalTrials.gov Identifier:
NCT00600522
First received: January 14, 2008
Last updated: NA
Last verified: January 2008
History: No changes posted
  Purpose

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 Intervention
Colorectal Liver Metastases
Hepatocellular Carcinoma
Procedure: Ultrasound-guided hepatectomy

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Milan:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 15
Study Start Date: January 2004
Study Completion Date: May 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
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.

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.

  Eligibility

Genders Eligible for Study:   Both
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

Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00600522

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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Guido Torzilli, University of Milan - Istituto Clinico Humanitas, IRCCS
ClinicalTrials.gov Identifier: NCT00600522     History of Changes
Other Study ID Numbers: HEP-MHV, NEWHEP-2
Study First Received: January 14, 2008
Last Updated: January 14, 2008
Health Authority: Italy: Ministry of Health
Italy: Regione Lombardia, Assessorato alla Sanità

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

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

ClinicalTrials.gov processed this record on November 20, 2014