Liver NeoplasmsNCT03577067
Complicated Outcome Prediction After Liver Resection
An observational study of Liver Neoplasms, run by University of Milan.
Trial summary
Although mortality after liver surgery reduced during the last three decades to less than 2%, post-operative course is still complicated in a range of 20-50% of cases.The identification of one or few factors which could detect the real risk of complicated post-operative outcome, may help anesthesiologist to decide… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Neoplasms
- What is being tested?
- Liver resection for primary and secondary disease
- Type of treatment
- Surgery or procedure
- How many people
- 183 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Mar 2017
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients resectable and affected by primary and secondary liver disease
Who may be able to join
- Patients resectable and affected by primary and secondary liver disease
Who cannot join
- Subjects affected by kidney disease and/or cirrhosis and pregnant patients were excluded from the trial. Patients who should have needed nephrectomy during the operation would be also excluded.
About this study
Official title: Complicated Outcome Prediction After Liver Resection: the Role of Renal Resistive Index
Although mortality after liver surgery reduced during the last three decades to less than 2%, post-operative course is still complicated in a range of 20-50% of cases.The identification of one or few factors which could detect the real risk of complicated post-operative outcome, may help anesthesiologist to decide whether admit a patient to ICU or not.The primary aim of this study was to evaluate whether RRI, alone or along with other items, can predict post-operative complication after hepatic resection.
- Conditions
- Liver Neoplasms
- Being tested
- Liver resection for primary and secondary disease
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver resection for primary and secondary diseaseProcedure or surgery
Liver resection in parenchyma-sparing setting for primary and secondary disease
| Study group | Role | What they receive |
|---|---|---|
| Patients submitted to liver resection | Patients underwent liver resection for primary and secondary disease Receives: Procedure: Liver resection for primary and secondary disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
renal resistive index (RRI)
the association between RRI and occurrence of hepatic complications during the first postoperative week.
Measured: up to 7 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 posted5 Jul 2018
- Study startFeb 2015
- Primary completionMar 2017
- Study completionMar 2017
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
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Guido Torzilli, Humanitas Clinical and Research Center
- Investigators
- Guido Torzilli, MD, PhD, Principal investigator, Humanitas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03577067
- Sponsor's protocol ID
- CE Humanitas 100/15
- Status last verified
- Jul 2018
- First submitted
- 28 May 2018
- Last updated
- 5 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complicated Outcome Prediction After Liver Resection: the Role of Renal Resistive Index
- ClinicalTrials.gov ID
- NCT03577067
- Acronym / sponsor ID
- CE Humanitas 100/15
- Conditions
- Liver Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- Feb 2015 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 5 Jul 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.
Although mortality after liver surgery reduced during the last three decades to less than 2%, post-operative course is still complicated in a range of 20-50% of cases.The identification of one or few factors which could detect the real risk of complicated post-operative outcome, may help anesthesiologist to decide whether admit a patient to ICU or not.The primary aim of this study was to evaluate whether RRI, alone or along with other items, can predict post-operative complication after hepatic resection.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients submitted to liver resection | – | Procedure: Liver resection for primary and secondary diseasePatients underwent liver resection for primary and secondary disease |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients resectable and affected by primary and secondary liver disease
Key inclusion criteria (1 listed)
- Patients resectable and affected by primary and secondary liver disease
Key exclusion criteria (1 listed)
- Subjects affected by kidney disease and/or cirrhosis and pregnant patients were excluded from the trial. Patients who should have needed nephrectomy during the operation would be also excluded.
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 |
|---|---|---|
| Liver resection for primary and secondary diseaseLiver resection in parenchyma-sparing setting for primary and secondary disease | Procedure or surgery | Patients submitted to liver resection |
Primary outcome
renal resistive index (RRI)
Time frame: up to 7 days after surgery
the association between RRI and occurrence of hepatic complications during the first postoperative week.
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 5 Jul 2018.
- 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.
Guido Torzilli, MD, PhD principal investigator
Humanitas University
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 5 Jul 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?
renal resistive index (RRI) (time frame: up to 7 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 5 Jul 2018.