NCT03476421

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
327

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2005

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
11 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2015

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 26, 2018

Completed
Last Updated

March 26, 2018

Status Verified

March 1, 2018

Enrollment Period

11 years

First QC Date

March 15, 2018

Last Update Submit

March 22, 2018

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Rates of local recurrence

    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

Study Arms (4)

R0 hepatectomy

Those HCC patients operated with standard R0 hepatectomy

Procedure: Hepatic resection

R1par hepatectomy

Those HCC patients operated with R1par hepatectomy

Procedure: Hepatic resection

R1vasc hepatectomy

Those HCC patients operated with R1vasc hepatectomy

Procedure: Hepatic resection

R1par+R1vasc hepatectomy

Those HCC patients operated with both R1par and R1vasc hepatectomy

Procedure: Hepatic resection

Interventions

Hepatic resectionPROCEDURE

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

R0 hepatectomyR1par hepatectomyR1par+R1vasc hepatectomyR1vasc hepatectomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with HCC (hepatocellular carcinoma) who underwent hepatectomy.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Torzilli G, Montorsi M, Donadon M, Palmisano A, Del Fabbro D, Gambetti A, Olivari N, Makuuchi M. "Radical but conservative" is the main goal for ultrasonography-guided liver resection: prospective validation of this approach. J Am Coll Surg. 2005 Oct;201(4):517-28. doi: 10.1016/j.jamcollsurg.2005.04.026.

    PMID: 16183489RESULT

  • Torzilli G, Donadon M, Palmisano A, Marconi M, Procopio F, Botea F, Del Fabbro D, Cappellani A, Montorsi M. Ultrasound guided liver resection: does this approach limit the need for portal vein embolization? Hepatogastroenterology. 2009 Sep-Oct;56(94-95):1483-90.

    PMID: 19950814RESULT

  • Vigano L, Procopio F, Cimino MM, Donadon M, Gatti A, Costa G, Del Fabbro D, Torzilli G. Is Tumor Detachment from Vascular Structures Equivalent to R0 Resection in Surgery for Colorectal Liver Metastases? An Observational Cohort. Ann Surg Oncol. 2016 Apr;23(4):1352-60. doi: 10.1245/s10434-015-5009-y. Epub 2015 Dec 29.

    PMID: 26714946RESULT

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of surgery, staff surgeon

Study Record Dates

First Submitted

March 15, 2018

First Posted

March 26, 2018

Study Start

January 1, 2005

Primary Completion

December 31, 2015

Study Completion

January 1, 2018

Last Updated

March 26, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share