Hepatocellular CarcinomaNCT03476421
R1vascular Hepatectomy for HCC Patients
An observational study of Hepatocellular Carcinoma, run by Humanitas Clinical and Research Center.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Hepatic resection
- Type of treatment
- Surgery or procedure
- How many people
- 327 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2005to 1 Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with HCC (hepatocellular carcinoma) who underwent hepatectomy.
Who may be able to join
- 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
Who cannot join
- patients who underwent vascular resection for direct infiltration of the vessel wall
- patients who had radiofrequency ablation in association to surgery
About this study
Official title: 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.
Read the 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.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Hepatic resection
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hepatic resectionProcedure or surgery
Surgery of the liver; removal of a part of the liver
| Study group | Role | What they receive |
|---|---|---|
| R0 hepatectomy | Those HCC patients operated with standard R0 hepatectomy Receives: Procedure: Hepatic resection | |
| R1par hepatectomy | Those HCC patients operated with R1par hepatectomy Receives: Procedure: Hepatic resection | |
| R1vasc hepatectomy | Those HCC patients operated with R1vasc hepatectomy Receives: Procedure: Hepatic resection | |
| R1par+R1vasc hepatectomy | Those HCC patients operated with both R1par and R1vasc hepatectomy Receives: Procedure: Hepatic resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of local recurrence
Calculation of the local recurrence (cut-edge tumor re-growth) of R0, R1par, and R1vasc, and R1par+R1vasc hepatectomy.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2018
- Study start1 Jan 2005
- Primary completion31 Dec 2015
- Study completion1 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 327 participants (actual)
Sponsor and investigators
- Lead sponsor
- Humanitas Clinical and Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matteo Donadon, Humanitas Clinical and Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03476421
- Sponsor's protocol ID
- HCC R1vasc
- Status last verified
- Mar 2018
- First submitted
- 15 Mar 2018
- Last updated
- 26 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 16183489Torzilli 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.
PubMed 19950814Vigano 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.
PubMed 26714946
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is R1 Vascular Hepatectomy for Hepatocellular Carcinoma Oncologically Adequate?
- ClinicalTrials.gov ID
- NCT03476421
- Acronym / sponsor ID
- HCC R1vasc
- Conditions
- Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 327 participants (actual)
- Lead sponsor
- Humanitas Clinical and Research CenterUniversity, hospital or other
- Study start
- 1 Jan 2005 (actual)
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 1 Jan 2018 (actual)
- First posted
- 26 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| R0 hepatectomy | – | Procedure: Hepatic resectionThose HCC patients operated with standard R0 hepatectomy |
| R1par hepatectomy | – | Procedure: Hepatic resectionThose HCC patients operated with R1par hepatectomy |
| R1vasc hepatectomy | – | Procedure: Hepatic resectionThose HCC patients operated with R1vasc hepatectomy |
| R1par+R1vasc hepatectomy | – | Procedure: Hepatic resectionThose HCC patients operated with both R1par and R1vasc hepatectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with HCC (hepatocellular carcinoma) who underwent hepatectomy.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- patients who underwent vascular resection for direct infiltration of the vessel wall
- patients who had radiofrequency ablation in association to surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hepatic resectionSurgery of the liver; removal of a part of the liver | Procedure or surgery | R0 hepatectomy, R1par hepatectomy, R1par+R1vasc hepatectomy, R1vasc hepatectomy |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2018.
- Results publication: PubMed 16183489Torzilli 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.
- Results publication: PubMed 19950814Torzilli 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.
- Results publication: PubMed 26714946Vigano 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma, run by Humanitas Clinical and Research Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03476421, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2018.