Secondary Malignant Neoplasm of LiverNCT02391207
Hepatic Vein-sparing Hepatectomy for Colorectal Liver Metastases at the Caval Confluence
An observational study of Secondary Malignant Neoplasm of Liver, run by University of Milan at 1 site in Italy.
Trial summary
Major hepatectomies are generally selected for tumors involving the hepatic vein (HV) at the caval confluence (CC). As alternative, HV reconstruction has been proposed. The present study aimed to evaluate the feasibility and safety of a HV-sparing policy guided by intraoperative ultrasonography (IOUS) in a cohort of… Read more about this study
- Who is it for?
- Ages 28 to 79 years
- Conditions the study is for
- Secondary Malignant Neoplasm of Liver
- What is being tested?
- Hepatic vein-sparing hepatectomy
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2009to Dec 2014
- 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 28 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patiens undergoing hepatectomy for primary and secondary liver tumors
Who may be able to join
- diagnosis of at least one CLM in contact with HV at caval confluence and HV patency at preoperative imaging
- at least 6 months of follow-up after surgery
Who cannot join
- suspected or ascertained thrombosis or full tumoral involvement of HV at preoperative imaging
- portal pedicle infiltration and/or thrombosis
- unresectability at laparotomy for any extra-hepatic or intrahepatic reason not related to tumor-vessel relations
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Hepatobiliary and General Surgery, Humanitas Research Hospital, University of Milan
Rozzano, Milan, 20089
About this study
Official title: Hepatic Vein-sparing Hepatectomy for Colorectal Liver Metastases at the Caval Confluence: Validation on Intention-to-treat Analysis of a IOUS-guided Approach
Major hepatectomies are generally selected for tumors involving the hepatic vein (HV) at the caval confluence (CC). As alternative, HV reconstruction has been proposed. The present study aimed to evaluate the feasibility and safety of a HV-sparing policy guided by intraoperative ultrasonography (IOUS) in a cohort of patients having at least one colorectal liver metastasis (CLM) in contact with a HV at CC. HV section can be avoided in the large majority of cases thanking to CLMs detachment or to HV partial resection or reconstruction: this policy seems feasible, safe, reduces the need of major hepatectomies, and oncologically provides an adequate local control.
- Conditions
- Secondary Malignant Neoplasm of Liver
- Being tested
- Hepatic vein-sparing hepatectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hepatic vein-sparing hepatectomyProcedure or surgery
HV detachment, partial resection and section on the basis of HV-CLM relationship
| Study group | Role | What they receive |
|---|---|---|
| patients having at least one CLM | Hepatic vein-sparing hepatectomy guided by intraoperative ultrasonography Receives: Procedure: Hepatic vein-sparing hepatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the safety of HV-sparing surgery in terms of operative mortality and morbidity
Measured: within 30-90 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2015 (estimated)
- Study startJan 2009
- Primary completionDec 2012
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secondary Malignant Neoplasm of LiverStudies 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Guido Torzilli, University of Milan
- Investigators
- Guido Torzilli, MD,PhD,FACS, Study director, Department of Hepatobiliary and General Surgery, University of Milan, Humanitas Research Hospital, Rozzano, Milan, ItalyFabio Procopio, MD, Principal investigator, Department of Hepatobiliary and General Surgery, University of Milan, Humanitas Research Hospital, Rozzano, Milan, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02391207
- Sponsor's protocol ID
- HV-SparingHx
- Status last verified
- Mar 2015
- First submitted
- 7 Mar 2015
- Last updated
- 18 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatic Vein-sparing Hepatectomy for Colorectal Liver Metastases at the Caval Confluence: Validation on Intention-to-treat Analysis of a IOUS-guided Approach
- ClinicalTrials.gov ID
- NCT02391207
- Acronym / sponsor ID
- HV-SparingHx
- Conditions
- Secondary Malignant Neoplasm of Liver
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 18 Mar 2015 (estimated)
- 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.
Major hepatectomies are generally selected for tumors involving the hepatic vein (HV) at the caval confluence (CC). As alternative, HV reconstruction has been proposed. The present study aimed to evaluate the feasibility and safety of a HV-sparing policy guided by intraoperative ultrasonography (IOUS) in a cohort of patients having at least one colorectal liver metastasis (CLM) in contact with a HV at CC. HV section can be avoided in the large majority of cases thanking to CLMs detachment or to HV partial resection or reconstruction: this policy seems feasible, safe, reduces the need of major hepatectomies, and oncologically provides an adequate local control.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients having at least one CLM | – | Procedure: Hepatic vein-sparing hepatectomyHepatic vein-sparing hepatectomy guided by intraoperative ultrasonography |
Who may qualify
- Ages
- 28 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patiens undergoing hepatectomy for primary and secondary liver tumors
Key inclusion criteria (2 listed)
- diagnosis of at least one CLM in contact with HV at caval confluence and HV patency at preoperative imaging
- at least 6 months of follow-up after surgery
Key exclusion criteria (3 listed)
- suspected or ascertained thrombosis or full tumoral involvement of HV at preoperative imaging
- portal pedicle infiltration and/or thrombosis
- unresectability at laparotomy for any extra-hepatic or intrahepatic reason not related to tumor-vessel relations
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 vein-sparing hepatectomyHV detachment, partial resection and section on the basis of HV-CLM relationship | Procedure or surgery | patients having at least one CLM |
Primary outcome
the safety of HV-sparing surgery in terms of operative mortality and morbidity
Time frame: within 30-90 days after surgery
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 18 Mar 2015.
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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.
Guido Torzilli, MD,PhD,FACS study director
Department of Hepatobiliary and General Surgery, University of Milan, Humanitas Research Hospital, Rozzano, Milan, Italy
Fabio Procopio, MD principal investigator
Department of Hepatobiliary and General Surgery, University of Milan, Humanitas Research Hospital, Rozzano, Milan, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Secondary Malignant Neoplasm of Liver, run by University of Milan at 1 site in Italy.
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 3 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 18 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
the safety of HV-sparing surgery in terms of operative mortality and morbidity (time frame: within 30-90 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Mar 2015.