R1vascular Hepatectomy for HCC Patients

Hepatocellular Carcinoma Clinical Trial

Official title:

Is R1 Vascular Hepatectomy for Hepatocellular Carcinoma Oncologically Adequate?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03476421
• Other study ID #: HCC R1vasc
• Status: Completed
• First received: March 15, 2018
• Last updated: March 22, 2018
• Start date: January 1, 2005
• Est. completion date: January 1, 2018

Study information

• Verified date: March 2018
• Source: Humanitas Clinical and Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 327
• Est. completion date: January 1, 2018
• Est. primary completion date: December 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Procedure:
• Hepatic resection
Surgery of the liver; removal of a part of the liver

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Humanitas Clinical and Research Center

References & Publications (3)

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):1 — View Citation

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( — View Citation

Viganò 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;2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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