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NCT Number: NCT03476421

R1vascular Hepatectomy for HCC Patients

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.

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hepatic resection

Procedure

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

Primary outcomes

  1. Rates of local recurrence

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Humanitas Clinical and Research Center

Other

Registry information

Official study title

Is R1 Vascular Hepatectomy for Hepatocellular Carcinoma Oncologically Adequate?

Important dates

Study start
2005
Primary completion
2015
Study completion
2018
First posted
Mar 26, 2018
Registry last updated
Mar 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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