- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03504358
A New Prognostic Scoring System for Spontaneous Ruptured Hepatocellular
April 12, 2018 updated by: Xiaoping Chen, Huazhong University of Science and Technology
A New Prognostic Scoring System for Spontaneous Ruptured Hepatocellular Carcinoma: A Retrospective Study
Develop a new scoring system for HCC patients with tumor rupture.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
There has been no special prognostic scoring system for HCC patients with tumor rupture in the literature.
In this work, we obtained all survival risk factors of ruptured HCC patients who underwent partial hepatectomy using multivariable Cox regression analysis.
Furthermore, we develop and validate a new postoperative scoring system for patients with spontaneous HCC rupture based on the these results.
Study Type
Observational
Enrollment (Actual)
129
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 75 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Ten year HCC rupture patients who received partial hepatectomy at Tongji Hospital of the Huazhong University of Science and Technology
Description
Inclusion Criteria:
- Received partial hepatectomy; with Child A or B liver function.
Exclusion Criteria:
- Without complete data;loss of follow-up; had reveived repeated transcatheter arterial chemoembolization before rupture; received non-radical resection.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Analysis before liver resection
Multivariate analysis of predictive factors associated with survival
|
Partial hepatectomy comprised single or multiple hepatic resections aiming at excising all visible malignant tissue.
|
|
Different risk group
Low-risk group, moderate-risk group, high-risk group
|
Partial hepatectomy comprised single or multiple hepatic resections aiming at excising all visible malignant tissue.
|
|
Model comparison
Comparison of models in predicting survival
|
Partial hepatectomy comprised single or multiple hepatic resections aiming at excising all visible malignant tissue.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall survival
Time Frame: 3 years
|
Overall survival after partial hepatectomy
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Disease-free survival
Time Frame: 3 years
|
Recurrence-free survival after partial hepatectomy
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Bi-xiang Zhang, Prof, PHD, Huazhong University of Science and Technology
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2005
Primary Completion (Actual)
May 1, 2015
Study Completion (Actual)
December 31, 2017
Study Registration Dates
First Submitted
April 4, 2018
First Submitted That Met QC Criteria
April 12, 2018
First Posted (Actual)
April 20, 2018
Study Record Updates
Last Update Posted (Actual)
April 20, 2018
Last Update Submitted That Met QC Criteria
April 12, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Zhupeng002
Drug and device information, study documents
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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