Clinical trial NCT03476421: R1vascular Hepatectomy for HCC Patients
Official title: Is R1 Vascular Hepatectomy for Hepatocellular Carcinoma Oncologically Adequate?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma
Lead sponsor: Humanitas Clinical and Research Center
Sponsor class: OTHER
First posted: 2018-03-26
Enrollment: 327
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with HCC (hepatocellular carcinoma) who underwent hepatectomy.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rates of local recurrence
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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(4):517-28. doi: 10.1016/j.jamcollsurg.2005.04.026.
citation: 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.
citation: 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.