R1vascular Hepatectomy for HCC Patients

March 22, 2018 updated by: Matteo Donadon, Humanitas Clinical and Research Center

Is R1 Vascular Hepatectomy for Hepatocellular Carcinoma Oncologically Adequate?

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

327

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with HCC (hepatocellular carcinoma) who underwent hepatectomy.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
R0 hepatectomy
Those HCC patients operated with standard R0 hepatectomy
Procedure: Hepatic resection
Surgery of the liver; removal of a part of the liver
R1par hepatectomy
Those HCC patients operated with R1par hepatectomy
Procedure: Hepatic resection
Surgery of the liver; removal of a part of the liver
R1vasc hepatectomy
Those HCC patients operated with R1vasc hepatectomy
Procedure: Hepatic resection
Surgery of the liver; removal of a part of the liver
R1par+R1vasc hepatectomy
Those HCC patients operated with both R1par and R1vasc hepatectomy
Procedure: Hepatic resection
Surgery of the liver; removal of a part of the liver

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Humanitas Clinical and Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2005

Primary Completion (Actual)

December 31, 2015

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

March 15, 2018

First Submitted That Met QC Criteria

March 22, 2018

First Posted (Actual)

March 26, 2018

Study Record Updates

Last Update Posted (Actual)

March 26, 2018

Last Update Submitted That Met QC Criteria

March 22, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCC R1vasc

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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