Alternative Surgical Policy for Central Liver Tumors
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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 |
- 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 ]
- 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:
|
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 |
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.
Contacts and Locations| Italy | |
| Istituto Clinico Humanitas, IRCCS | |
| Rozzano, Milano, Italy, 20089 | |
| 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 Neoplasm Metastasis Liver Neoplasms Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Neoplastic Processes Pathologic Processes Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases Adenocarcinoma |
ClinicalTrials.gov processed this record on May 23, 2013