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A Comparison Between Child-Pugh and Albumin-Bilirubin Scores

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03534843
Recruitment Status : Completed
First Posted : May 23, 2018
Last Update Posted : May 29, 2018
Sponsor:
Information provided by (Responsible Party):
Xiaoping Chen, Huazhong University of Science and Technology

Study Description
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Brief Summary:
To compare Child-Pugh and Albumin-Bilirubin scores in patients with spontaneous rupture of hepatocellular carcinoma

Condition or disease Intervention/treatment
Rupture, Spontaneous Rupture Liver Hepatocellular Carcinoma Hepatic Impairment Procedure: Liver resection Other: Transcatheter arterial embolization

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 Design
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Study Type : Observational
Actual Enrollment : 230 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Comparison Between Child-Pugh and Albumin-Bilirubin Scores in Patients With Spontaneous Rupture of Hepatocellular Carcinoma: A Retrospective Study
Actual Study Start Date : January 1, 2005
Actual Primary Completion Date : August 1, 2015
Actual Study Completion Date : January 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Groups and Cohorts
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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.
 Procedure: Liver resection
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
 Other: Transcatheter arterial embolization
Transcatheter arterial embolization or transcatheter arterial chemoembolization can localize the bleeding point and provide interventional embolization.


Outcome Measures
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Primary Outcome Measures :
  1. Overall survival of all patients [ Time Frame: 5 years ]
    Overall survival of all patients among different Child-Pugh and albumin-bilirubin scores


Secondary Outcome Measures :
  1. Short-term mortality of all patients [ Time Frame: Ninety days ]
    Ninety-day mortality of all patients among different Child-Pugh and albumin-bilirubin scores

  2. 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

  3. 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


Eligibility Criteria
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Ages Eligible for Study:   15 Years to 76 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03534843


Sponsors and Collaborators
Huazhong University of Science and Technology
Investigators
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Study Chair: Xiao-ping Chen, Prof. PHD Huazhong University of Science and Technology
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Xiaoping Chen, Professor, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT03534843    
Other Study ID Numbers: Chenxp011
First Posted: May 23, 2018    Key Record Dates
Last Update Posted: May 29, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xiaoping Chen, Huazhong University of Science and Technology:
Spontaneous rupture
survival
hepatocellular carcinoma
Child-Pugh
Albumin-bilirubin
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Rupture, Spontaneous
Rupture
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
 Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Wounds and Injuries
Pathological Conditions, Anatomical