Liver NeoplasmsIVCNCT02404909
Inferior Vena Cava Index in Patients Undergoing Liver Resection
An observational study of Liver Neoplasms, run by University of Milan.
Trial summary
The aim of this study was to evaluate whether IVC index measured intraoperatively was affected by fluid administration and could add any helpful information about the hemodynamics during hepatic resection. Read more about this study
- Who is it for?
- Ages 34 to 85 years
- Conditions the study is for
- Liver Neoplasms
- What is being tested?
- IVC diameters evaluation by intraoperative ultrasound
- How many people
- 91 participants
- Where
- No sites listed yet
- Study dates
- Jan 2005to 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 34 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients underwent liver resection for primary and secondary liver disease
Who may be able to join
- Patients who underwent hepatectomy for primary and secondary liver tumors
Who cannot join
- Patients with tumoral thrombosis or full tumoral involvement/compression of IVC were excluded. Patients unresectable at laparotomy for any extra-hepatic or intrahepatic reason and patients previously submitted to hepatectomy were not included
About this study
Official title: Does Inferior Vena Cava Collapsibility Correlate With Fluid Regimen and Outcome in Patients Undergoing Liver Resection?
The aim of this study was to evaluate whether IVC index measured intraoperatively was affected by fluid administration and could add any helpful information about the hemodynamics during hepatic resection. In addition, the investigators evaluated whether IVC index was somehow correlated with the risk of postoperative complication.
- Conditions
- Liver Neoplasms
- Being tested
- IVC diameters evaluation by intraoperative ultrasound
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVC diameters evaluation by intraoperative ultrasoundOther
Out of consecutive patients who underwent hepatectomy for primary and secondary liver tumors, patients in whom IVC diameters were intraoperatively measured for clinical reasons were retrospectively selected and analyzed
| Study group | Role | What they receive |
|---|---|---|
| Patients with liver tumors candidate to hepatectomy | Not described Receives: Other: IVC diameters evaluation by intraoperative ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
to investigate the influence of the liver resection on hemodynamic status in terms of hemodynamic indexes changes
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2015 (estimated)
- Study startJan 2005
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver NeoplasmsStudies 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
- Retrospective
- Enrolment
- 91 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02404909
- Sponsor's protocol ID
- IVCindex
- Acronym
- IVC
- Status last verified
- Mar 2015
- First submitted
- 21 Mar 2015
- Last updated
- 1 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Inferior Vena Cava Collapsibility Correlate With Fluid Regimen and Outcome in Patients Undergoing Liver Resection?
- ClinicalTrials.gov ID
- NCT02404909
- Acronym / sponsor ID
- IVC / IVCindex
- Conditions
- Liver Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 1 Apr 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.
The aim of this study was to evaluate whether IVC index measured intraoperatively was affected by fluid administration and could add any helpful information about the hemodynamics during hepatic resection. In addition, the investigators evaluated whether IVC index was somehow correlated with the risk of postoperative complication.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with liver tumors candidate to hepatectomy | – | Other: IVC diameters evaluation by intraoperative ultrasound |
Who may qualify
- Ages
- 34 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients underwent liver resection for primary and secondary liver disease
Key inclusion criteria (1 listed)
- Patients who underwent hepatectomy for primary and secondary liver tumors
Key exclusion criteria (1 listed)
- Patients with tumoral thrombosis or full tumoral involvement/compression of IVC were excluded. Patients unresectable at laparotomy for any extra-hepatic or intrahepatic reason and patients previously submitted to hepatectomy were not included
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 |
|---|---|---|
| IVC diameters evaluation by intraoperative ultrasoundOut of consecutive patients who underwent hepatectomy for primary and secondary liver tumors, patients in whom IVC diameters were intraoperatively measured for clinical reasons were retrospectively selected and analyzed | Other | Patients with liver tumors candidate to hepatectomy |
Primary outcome
to investigate the influence of the liver resection on hemodynamic status in terms of hemodynamic indexes changes
Time frame: 4 weeks
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 1 Apr 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.
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 Liver Neoplasms, run by University of Milan.
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 1 inclusion and 1 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 1 Apr 2015. 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?
to investigate the influence of the liver resection on hemodynamic status in terms of hemodynamic indexes changes (time frame: 4 weeks). 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 1 Apr 2015.