R1vascular Hepatectomy for HCC Patients

NCT ID: NCT03476421

Last Updated: 2018-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

327 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-01-01

Study Completion Date

2018-01-01

Brief Summary

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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; ViganĂ² 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

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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.

Conditions

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Hepatocellular Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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R0 hepatectomy

Those HCC patients operated with standard R0 hepatectomy

Hepatic resection

Intervention Type PROCEDURE

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

R1par hepatectomy

Those HCC patients operated with R1par hepatectomy

Hepatic resection

Intervention Type PROCEDURE

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

R1vasc hepatectomy

Those HCC patients operated with R1vasc hepatectomy

Hepatic resection

Intervention Type PROCEDURE

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

R1par+R1vasc hepatectomy

Those HCC patients operated with both R1par and R1vasc hepatectomy

Hepatic resection

Intervention Type PROCEDURE

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

Interventions

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Hepatic resection

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Humanitas Clinical and Research Center

OTHER

Sponsor Role lead

Responsible Party

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Matteo Donadon

Assistant professor of surgery, staff surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type RESULT
PMID: 16183489 (View on PubMed)

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.

Reference Type RESULT
PMID: 19950814 (View on PubMed)

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.

Reference Type RESULT
PMID: 26714946 (View on PubMed)

Other Identifiers

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HCC R1vasc

Identifier Type: -

Identifier Source: org_study_id

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