Hepatic NeoplasmsNCT07169877
Does a Minimally Invasive Approach to Liver Resection Improve Postoperative Outcomes?
An observational study of Hepatic Neoplasms, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
A retrospective cohort study was conducted using the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database to identify adult patients who underwent liver resection between 2022 and 2023. Primary outcomes included 30-day mortality, sepsis, septic shock, readmission, and reoperation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatic Neoplasms
- How many people
- 9,411 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2022to 31 Dec 2023
- 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: Participants wit hepatic neoplasms
Who may be able to join
- Retrospective patients with condition only
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
A retrospective cohort study was conducted using the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database to identify adult patients who underwent liver resection between 2022 and 2023. Primary outcomes included 30-day mortality, sepsis, septic shock, readmission, and reoperation.
- Conditions
- Hepatic Neoplasms
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participant who underwent liver resection | Adult patients who underwent liver resection between January 2022 and December 2023. Data obtained from the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day mortality
Number of deaths at 30 days
Measured: 30 days
Number of participants with Sepsis
Number of participants with sepsis at 30 days
Measured: 30 days
Number of participants with Septic Shock
Number of participants with septic shock at 30 days
Measured: 30 days
Number of readmissions
Number of participants who had a remission at 30 days
Measured: 30 days
Number of reoperations
Number of participants who had an reoperation at 30 days
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start1 Jan 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- 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
- 9,411 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Leitman, Icahn School of Medicine at Mount Sinai
- Investigators
- Michael Leitman, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07169877
- Sponsor's protocol ID
- STUDY-25-00212
- Status last verified
- Sep 2025
- First submitted
- 5 Sep 2025
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does a Minimally Invasive Approach to Liver Resection Improve Postoperative Outcomes?
- ClinicalTrials.gov ID
- NCT07169877
- Acronym / sponsor ID
- STUDY-25-00212
- Conditions
- Hepatic Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9,411 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 12 Sep 2025 (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.
A retrospective cohort study was conducted using the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database to identify adult patients who underwent liver resection between 2022 and 2023. Primary outcomes included 30-day mortality, sepsis, septic shock, readmission, and reoperation.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participant who underwent liver resection | – | –Adult patients who underwent liver resection between January 2022 and December 2023. Data obtained from the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants wit hepatic neoplasms
Key inclusion criteria (1 listed)
- Retrospective patients with condition only
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
30-day mortality
Time frame: 30 days
Number of deaths at 30 days
Number of participants with Sepsis
Time frame: 30 days
Number of participants with sepsis at 30 days
Number of participants with Septic Shock
Time frame: 30 days
Number of participants with septic shock at 30 days
Number of readmissions
Time frame: 30 days
Number of participants who had a remission at 30 days
Number of reoperations
Time frame: 30 days
Number of participants who had an reoperation at 30 days
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 12 Sep 2025.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.
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Not yet recruitingPhase 1
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Active, not recruitingPhase 2
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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.
Michael Leitman, MD principal investigator
Icahn School of Medicine at Mount Sinai
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 Hepatic Neoplasms, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
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 12 Sep 2025. 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 United States. 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?
30-day mortality (time frame: 30 days). The study lists 5 primary outcomes in all. 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 12 Sep 2025.