NCT03504358

Brief Summary

Develop a new scoring system for HCC patients with tumor rupture.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
129

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2005

Longer than P75 for all trials

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, 2005

Completed
10.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 20, 2018

Completed
Last Updated

April 20, 2018

Status Verified

April 1, 2018

Enrollment Period

10.3 years

First QC Date

April 4, 2018

Last Update Submit

April 12, 2018

Conditions

Rupture, Spontaneous

Keywords

surgeryscoring systemhepatocellular carcinomahomogeneity and discriminatory abilitysurvival

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    Overall survival after partial hepatectomy

    3 years

Secondary Outcomes (1)

  • Disease-free survival

    3 years

Study Arms (3)

Analysis before liver resection

Multivariate analysis of predictive factors associated with survival

Procedure: Liver resection

Different risk group

Low-risk group, moderate-risk group, high-risk group

Procedure: Liver resection

Model comparison

Comparison of models in predicting survival

Procedure: Liver resection

Interventions

Liver resectionPROCEDURE

Partial hepatectomy comprised single or multiple hepatic resections aiming at excising all visible malignant tissue.

Analysis before liver resectionDifferent risk groupModel comparison

Eligibility Criteria

Age15 Years - 75 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Ten year HCC rupture patients who received partial hepatectomy at Tongji Hospital of the Huazhong University of Science and Technology

You may qualify if:

  • Received partial hepatectomy; with Child A or B liver function.

You may not qualify if:

  • Without complete data；loss of follow-up; had reveived repeated transcatheter arterial chemoembolization before rupture; received non-radical resection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Rupture, SpontaneousCarcinoma, Hepatocellular

Interventions

Hepatectomy

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Bi-xiang Zhang, Prof, PHD

    Huazhong University of Science and Technology

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

April 4, 2018

First Posted

April 20, 2018

Study Start

January 1, 2005

Primary Completion

May 1, 2015

Study Completion

December 31, 2017

Last Updated

April 20, 2018

Record last verified: 2018-04