R1vascular Hepatectomy for HCC Patients

Completed

• Conditions: Hepatocellular Carcinoma
• Interventions: Procedure: Hepatic resection

• Registration Number: NCT03476421
• Lead Sponsor: Humanitas Clinical and Research Center

Brief Summary

Since the previous decade, the authors introduced the R1 vascular (R1vasc) resection for the treatment of hepatocellular carcinoma (HCC), and colorectal liver metastases (Torzilli et al. J Am Coll Surg 2005; Viganò et al. Ann Surg Oncol 2016; Torzilli et al. Surgery 2017). However, oncological reliability of tumor exposure in surgery for HCC remains controversial since it has never been validated. The aim of the study is to determine the oncological adequacy of R1vasc hepatectomy in patients with HCC.

Detailed Description

A prospective cohort of patients who underwent hepatectomy for HCC between January 2005 and December 2015 is reviewed. The following definitions are adopted: R0 is any resection with at least 1 mm of negative margin; R1vasc is any resection with tumor exposure due to the detachment from major intrahepatic vessel (1st/2nd order glissonean pedicles and hepatic vein at caval confluence); R1-parenchymal (R1par) is any resection with tumor exposure at parenchymal margin.

Study Timeline

• Study Start: 2005-01-01
• Primary Completion: 2015-12-31
• Study Completion: 2018-01-01
• Status Verified: 2018-03
• Study First Submitted: 2018-03-15
• Study First Submitted QC: 2018-03-22
• Last Update Submitted: 2018-03-22
• Study First Posted: 2018-03-26
• Last Update Posted: 2018-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 327

Inclusion Criteria

• only patients with a primary untreated HCC were included;
• complete follow-up data with available computed tomography (CT) and/or magnetic resonance imaging (MRI) images showing the first recurrence

Exclusion Criteria

• patients who underwent vascular resection for direct infiltration of the vessel wall
• patients who had radiofrequency ablation in association to surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
R0 hepatectomy	Hepatic resection	Those HCC patients operated with standard R0 hepatectomy
R1vasc hepatectomy	Hepatic resection	Those HCC patients operated with R1vasc hepatectomy
R1par hepatectomy	Hepatic resection	Those HCC patients operated with R1par hepatectomy
R1par+R1vasc hepatectomy	Hepatic resection	Those HCC patients operated with both R1par and R1vasc hepatectomy

Primary Outcome Measures

Name	Time	Method
Rates of local recurrence	From date of surgery until the date of first documented progression or date of death from any cause, which ever came first assessed up to 72 months	Calculation of the local recurrence (cut-edge tumor re-growth) of R0, R1par, and R1vasc, and R1par+R1vasc hepatectomy.