Alternative Surgical Policy for Central Liver Tumors
| Tracking Information | |||||
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| First Received Date ICMJE | January 14, 2008 | ||||
| Last Updated Date | January 14, 2008 | ||||
| Start Date ICMJE | January 2004 | ||||
| Primary Completion Date | January 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Alternative Surgical Policy for Central Liver Tumors | ||||
| Official Title ICMJE | Ultrasound-Guided Conservative Heopatecomy for Tumors Invading the Middle Hepatic Vein at the Caval Confluence as Alternative to Mesohepatectomy and Trisectionectomy | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients carriers of hepatocellular carcinoma or colorectal cancer liver metastases addressed to surgical resection |
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| Condition ICMJE |
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| Intervention ICMJE | 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:
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| Study Group/Cohort (s) | 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).
Intervention: Procedure: Ultrasound-guided hepatectomy |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 15 | ||||
| Completion Date | May 2007 | ||||
| Primary Completion Date | January 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Minimum follow-up for patients' inclusion was established at 6-months from surgery. Exclusion Criteria:
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Italy | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00600522 | ||||
| Other Study ID Numbers ICMJE | HEP-MHV, NEWHEP-2 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Prof. Guido Torzilli, University of Milan - Istituto Clinico Humanitas, IRCCS | ||||
| Study Sponsor ICMJE | University of Milan | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Milan | ||||
| Verification Date | January 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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