R1vascular Hepatectomy for HCC Patients

Is R1 Vascular Hepatectomy for Hepatocellular Carcinoma Oncologically Adequate?

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03476421

Enrollment

327

Registered

2018-03-26

Start date

2005-01-01

Completion date

2018-01-01

Last updated

2018-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

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.

Interventions

PROCEDUREHepatic resection

Surgery of the liver; removal of a part of the liver

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026