Alternative Surgical Policy for Central Liver Tumors

Hepatocellular Carcinoma Clinical Trial

Official title:

Ultrasound-Guided Conservative Heopatecomy for Tumors Invading the Middle Hepatic Vein at the Caval Confluence as Alternative to Mesohepatectomy and Trisectionectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00600522
• Other study ID #: HEP-MHV
• Secondary ID: NEWHEP-2
• Status: Completed
• Phase: N/A
• First received: January 14, 2008
• Last updated: January 14, 2008
• Start date: January 2004
• Est. completion date: May 2007

Study information

• Verified date: January 2008
• Source: University of Milan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of HealthItaly: Regione Lombardia, Assessorato alla Sanità
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: May 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Colorectal Liver Metastases
• Hepatocellular Carcinoma

Intervention

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: 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. Detectable shunting collaterals at color-Doppler IOUS with RHV or LHV. 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.

Locations

Country	Name	City	State
Italy	Istituto Clinico Humanitas, IRCCS	Rozzano	Milano

Sponsors (1)

Lead Sponsor	Collaborator
University of Milan

Country where clinical trial is conducted

Italy, 

References & Publications (3)

Stratopoulos C, Soonawalla Z, Brockmann J, Hoffmann K, Friend PJ. Central hepatectomy: the golden mean for treating central liver tumors? Surg Oncol. 2007 Aug;16(2):99-106. Epub 2007 Jun 20. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		January 2007	No
Secondary	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.		January 2007	Yes