NCT06506318

Brief Summary

The goal of this observational study is to train a deep learning-based model to predict multidrug-resistant Klebsiella pneumoniae liver abscess and evaluate it on a multi-center database.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
550

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 3, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 17, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

July 17, 2024

Status Verified

July 1, 2024

Enrollment Period

12 months

First QC Date

July 3, 2024

Last Update Submit

July 11, 2024

Conditions

Keywords

Deep-learning; Liver Abscess

Outcome Measures

Primary Outcomes (2)

  • Result of bacteria culture

    The result of bacteria culture of abscess decides which group the patients belong. This result was obtained from bacteria culture tests which were done by department of laboratory medicine.

    The first time before surgery or interventional process, usually within 1 week, up to 4 weeks.

  • Result of drug resistant test

    Our destination is to find out the potential differences between Esbl(+) \& Esbl(-) liver abscess.

    The first time before surgery or interventional process, usually within 1 week, up to 4 weeks.

Study Arms (2)

Patients with ESBL(-) liver abscess

Patients with ESBL(+) liver abscess

Eligibility Criteria

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

Pyogenic liver abscess patients in 14years of a multicenter project.

You may qualify if:

  • Patients diagnosed as pyogenic liver abscess and was proved by surgery or interventional process.
  • Patients had accepted abdominal enhance CT scans before surgery or interventional process.

You may not qualify if:

  • Patients diagnosed with other types of liver abscess such as amoeba.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shengjing hospital of China medical university

Shenyang, Liaoning, 110004, China

RECRUITING

MeSH Terms

Conditions

Liver Abscess

Condition Hierarchy (Ancestors)

Abdominal AbscessAbscessSuppurationInfectionsLiver DiseasesDigestive System Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

July 3, 2024

First Posted

July 17, 2024

Study Start

January 1, 2024

Primary Completion

December 30, 2024

Study Completion

March 1, 2025

Last Updated

July 17, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations