- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03534843
A Comparison Between Child-Pugh and Albumin-Bilirubin Scores
May 24, 2018 updated by: Xiaoping Chen, Huazhong University of Science and Technology
A Comparison Between Child-Pugh and Albumin-Bilirubin Scores in Patients With Spontaneous Rupture of Hepatocellular Carcinoma: A Retrospective Study
To compare Child-Pugh and Albumin-Bilirubin scores in patients with spontaneous rupture of hepatocellular carcinoma
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
To compare Child-Pugh and Albumin-Bilirubin scores in patients with spontaneous rupture of hepatocellular carcinoma.
And to determine which is better in predicting long-term survival and short-term survival.
Study Type
Observational
Enrollment (Actual)
230
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 76 years (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
From January 2005 to August 2015, all patients complied with the criteria mentioned above who received surgical treatment or non-surgical treatment at the investigator's center were included in this study.
Description
Inclusion Criteria:
- Be diagnosed as hepatocellular carcinoma pathologically; had a tumor rupture confirmed by Intraperitoneal exploration or clinical signs and symptoms in combination with imaging examination.
Exclusion Criteria:
- Be diagnosed as not hepatocellular carcinoma pathologically;had repeated transcatheter arterial chemoembolization(TACE) or a long history (more than 1 year) of cancer treatment; loss of follow up or without complete data.
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Surgical treatment
Patients who received liver resection or palliative surgery, such as microwave coagulation therapy, hepatic artery ligation, or suturing ligation.
|
Liver resection was comprised of single or multiple liver resections aiming to excise all macroscopic tumors.
|
Non-surgical treatment
Patients who received transcatheter arterial embolization (or transcatheter arterial chemoembolization) or conservative treatment
|
Transcatheter arterial embolization or transcatheter arterial chemoembolization can localize the bleeding point and provide interventional embolization.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival of all patients
Time Frame: 5 years
|
Overall survival of all patients among different Child-Pugh and albumin-bilirubin scores
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Short-term mortality of all patients
Time Frame: Ninety days
|
Ninety-day mortality of all patients among different Child-Pugh and albumin-bilirubin scores
|
Ninety days
|
Short-term mortality of surgical subgroup
Time Frame: Ninety days
|
Ninety-day mortality of the surgical subgroup among different Child-Pugh and albumin-bilirubin scores
|
Ninety days
|
Short-term mortality of non-surgical subgroup
Time Frame: Ninety days
|
Ninety-day mortality of the non-surgical subgroup among different Child-Pugh and albumin-bilirubin scores
|
Ninety days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Xiao-ping Chen, Prof. PHD, Huazhong University of Science and Technology
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
August 1, 2015
Study Completion (ACTUAL)
January 1, 2018
Study Registration Dates
First Submitted
May 12, 2018
First Submitted That Met QC Criteria
May 22, 2018
First Posted (ACTUAL)
May 23, 2018
Study Record Updates
Last Update Posted (ACTUAL)
May 29, 2018
Last Update Submitted That Met QC Criteria
May 24, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Wounds and Injuries
- Digestive System Neoplasms
- Liver Diseases
- Liver Neoplasms
- Pathological Conditions, Anatomical
- Carcinoma
- Carcinoma, Hepatocellular
- Rupture
- Rupture, Spontaneous
Other Study ID Numbers
- Chenxp011
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
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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