- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03516890
Management of Spontaneous Ruptured Hepatocellular Carcinoma
May 3, 2018 updated by: Xiaoping Chen, Huazhong University of Science and Technology
Management of Spontaneous Ruptured Hepatocellular Carcinoma - Partial Hepatectomy and Prognosis: A Retrospective Study
To investigate the best treatment for hepatocellular carcinoma rupture
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
To investigate the best treatment for hepatocellular carcinoma rupture, transcatheter arterial embolization or partial hepatectomy.
Furthermore, to discuss the choice of emergency or staged hepatectomy.
Study Type
Observational
Enrollment (Actual)
216
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 (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
From January 2005 to June 2015, all patients complied with the criteria mentioned above who received partial hepatectomy or non-surgical at our center were included in this study.
Description
Inclusion Criteria:
- Being diagnosed as hepatocellular carcinoma with tumor rupture; with complete data and without loss of follow-up
Exclusion Criteria:
- Without complete data; with loss of follow-up; not hepatocellular carcinoma based on pathological diagnosis
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
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 difference between the partial hepatectomy group and the non-surgical group
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative peritoneal dissemination
Time Frame: 5 years
|
Postoperative peritoneal dissemination diagnosed by imaging examination
|
5 years
|
|
Recurrence-free survival of all patients
Time Frame: 5 years
|
Recurrence-free survival difference between the partial hepatectomy group and the non-surgical group
|
5 years
|
|
Overall survival of partial hepatectomy patients
Time Frame: 5 years
|
Overall survival difference between the emergency partial hepatectomy group and the staged partial hepatectomy group
|
5 years
|
|
Recurrence-free survival of partial hepatectomy patients
Time Frame: 5 years
|
Recurrence-free survival difference between the emergency partial hepatectomy group and the staged partial hepatectomy group
|
5 years
|
|
Overall survival of staged partial hepatectomy patients
Time Frame: 5 years
|
Overall survival difference between the staged early partial hepatectomy group and the staged late partial hepatectomy group
|
5 years
|
|
Recurrence-free of staged partial hepatectomy patients
Time Frame: 5 years
|
Recurrence-free survival difference between the staged early partial hepatectomy group and the staged late partial hepatectomy group
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Xiao-ping Chen, 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)
June 1, 2015
Study Completion (Actual)
December 1, 2017
Study Registration Dates
First Submitted
April 4, 2018
First Submitted That Met QC Criteria
May 3, 2018
First Posted (Actual)
May 4, 2018
Study Record Updates
Last Update Posted (Actual)
May 4, 2018
Last Update Submitted That Met QC Criteria
May 3, 2018
Last Verified
April 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
- Chenxp010
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.