Alternative Surgical Policy for Central Liver Tumors

Completed

• Conditions: Colorectal Liver Metastases; Hepatocellular Carcinoma
• Interventions: Procedure: Ultrasound-guided hepatectomy

• Registration Number: NCT00600522
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2004-01
• Primary Completion: 2007-01
• Study Completion: 2007-05
• Status Verified: 2008-01
• Study First Submitted: 2008-01-14
• Study First Submitted QC: 2008-01-14
• Last Update Submitted: 2008-01-14
• Study First Posted: 2008-01-25
• Last Update Posted: 2008-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Ultrasound-guided hepatectomy	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).

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Istituto Clinico Humanitas, IRCCS; 🇮🇹 Rozzano, Milano, Italy