NCT07169877

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9,411

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 5, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 12, 2025

Completed
Last Updated

September 12, 2025

Status Verified

September 1, 2025

Enrollment Period

2 years

First QC Date

September 5, 2025

Last Update Submit

September 5, 2025

Conditions

Outcome Measures

Primary Outcomes (5)

  • 30-day mortality

    Number of deaths at 30 days

    30 days

  • Number of participants with Sepsis

    Number of participants with sepsis at 30 days

    30 days

  • Number of participants with Septic Shock

    Number of participants with septic shock at 30 days

    30 days

  • Number of readmissions

    Number of participants who had a remission at 30 days

    30 days

  • Number of reoperations

    Number of participants who had an reoperation at 30 days

    30 days

Study Arms (1)

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)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants wit hepatic neoplasms

You may qualify if:

  • \- Retrospective patients with condition only

You may not qualify if:

  • \- none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver Diseases

Study Officials

  • Michael Leitman, MD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dean for Graduate Medical Education and Designated Institutional Official, Professor of Surgery

Study Record Dates

First Submitted

September 5, 2025

First Posted

September 12, 2025

Study Start

January 1, 2022

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

September 12, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

All of the individual participant data collected during the trial, after deidentification.

Shared Documents
STUDY PROTOCOL
Time Frame
Immediately following publication. No end date.
Access Criteria
Investigators whose proposed use of the data has been approved by an independent review committee ('learned intermediary') identified for this purpose. For individual participant data meta-analysis. Data are available indefinitely at (Link included in the URL field below).
More information

Locations