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R1vascular Hepatectomy for HCC Patients

H

Humanitas Clinical and Research Center

Status

Completed

Conditions

Hepatocellular Carcinoma

Treatments

Procedure: Hepatic resection

Study type

Observational

Funder types

Other

Identifiers

NCT03476421
HCC R1vasc

Details and patient eligibility

About

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.

Full 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.

Enrollment

327 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

327 participants in 4 patient groups

R0 hepatectomy
Description:
Those HCC patients operated with standard R0 hepatectomy
Treatment:
Procedure: Hepatic resection
R1par hepatectomy
Description:
Those HCC patients operated with R1par hepatectomy
Treatment:
Procedure: Hepatic resection
R1vasc hepatectomy
Description:
Those HCC patients operated with R1vasc hepatectomy
Treatment:
Procedure: Hepatic resection
R1par+R1vasc hepatectomy
Description:
Those HCC patients operated with both R1par and R1vasc hepatectomy
Treatment:
Procedure: Hepatic resection

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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