Rupture, SpontaneousNCT03516890
Management of Spontaneous Ruptured Hepatocellular Carcinoma
An observational study of Rupture, Spontaneous and Rupture Liver, run by Huazhong University of Science and Technology.
Trial summary
To investigate the best treatment for hepatocellular carcinoma rupture Read more about this study
- Who is it for?
- Ages 15 to 76 years
- Conditions the study is for
- Rupture, Spontaneous, Rupture Liver, Hepatocellular Carcinoma
- What is being tested?
- Partial hepatectomy
- Type of treatment
- Surgery or procedure
- How many people
- 216 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2005to 1 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 76 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Being diagnosed as hepatocellular carcinoma with tumor rupture; with complete data and without loss of follow-up
Who cannot join
- Without complete data; with loss of follow-up; not hepatocellular carcinoma based on pathological diagnosis
About this study
Official title: Management of Spontaneous Ruptured Hepatocellular Carcinoma - Partial Hepatectomy and Prognosis: A Retrospective Study
To investigate the best treatment for hepatocellular carcinoma rupture
Read the 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.
- Being tested
- Partial hepatectomy
- Keywords
- Partial hepatectomy, Emergency, Staged, Peritoneal dissemination, Propensity score matching
- Medical subject headings
- Rupture, Spontaneous, Carcinoma, Hepatocellular, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partial hepatectomyProcedure or surgery
Partial hepatectomy was comprised of single or multiple liver resections aiming to excise all macroscopic tumors.
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival of all patients
Overall survival difference between the partial hepatectomy group and the non-surgical group
Measured: 5 years
Secondary outcomes (6)
Postoperative peritoneal dissemination
Postoperative peritoneal dissemination diagnosed by imaging examination
Measured: 5 years
Recurrence-free survival of all patients
Recurrence-free survival difference between the partial hepatectomy group and the non-surgical group
Measured: 5 years
Overall survival of partial hepatectomy patients
Overall survival difference between the emergency partial hepatectomy group and the staged partial hepatectomy group
Measured: 5 years
Recurrence-free survival of partial hepatectomy patients
Recurrence-free survival difference between the emergency partial hepatectomy group and the staged partial hepatectomy group
Measured: 5 years
Overall survival of staged partial hepatectomy patients
Overall survival difference between the staged early partial hepatectomy group and the staged late partial hepatectomy group
Measured: 5 years
Recurrence-free of staged partial hepatectomy patients
Recurrence-free survival difference between the staged early partial hepatectomy group and the staged late partial hepatectomy group
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2018
- Study start1 Jan 2005
- Primary completion1 Jun 2015
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rupture, SpontaneousStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaoping Chen, Huazhong University of Science and Technology
- Investigators
- Xiao-ping Chen, PHD, Study chair, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03516890
- Sponsor's protocol ID
- Chenxp010
- Status last verified
- Apr 2018
- First submitted
- 4 Apr 2018
- Last updated
- 4 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Spontaneous Ruptured Hepatocellular Carcinoma - Partial Hepatectomy and Prognosis: A Retrospective Study
- ClinicalTrials.gov ID
- NCT03516890
- Acronym / sponsor ID
- Chenxp010
- Keywords
- Partial hepatectomy, Emergency, Staged, Peritoneal dissemination, Propensity score matching
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Jan 2005 (actual)
- Primary completion
- 1 Jun 2015 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 4 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the best treatment for hepatocellular carcinoma rupture
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 15 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Being diagnosed as hepatocellular carcinoma with tumor rupture; with complete data and without loss of follow-up
Key exclusion criteria (1 listed)
- Without complete data; with loss of follow-up; not hepatocellular carcinoma based on pathological diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Partial hepatectomyPartial hepatectomy was comprised of single or multiple liver resections aiming to excise all macroscopic tumors. | Procedure or surgery | – |
Primary outcome
Overall survival of all patients
Time frame: 5 years
Overall survival difference between the partial hepatectomy group and the non-surgical group
6 secondary outcomes
Postoperative peritoneal dissemination
Time frame: 5 years
Recurrence-free survival of all patients
Time frame: 5 years
Overall survival of partial hepatectomy patients
Time frame: 5 years
Recurrence-free survival of partial hepatectomy patients
Time frame: 5 years
Overall survival of staged partial hepatectomy patients
Time frame: 5 years
Recurrence-free of staged partial hepatectomy patients
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiao-ping Chen, PHD study chair
Huazhong University of Science and Technology
Questions about this trial
What is this clinical trial studying?
An observational study of Rupture, Spontaneous and Rupture Liver, run by Huazhong University of Science and Technology.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival of all patients (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2018; AzTrials last refreshed its copy on 7 Nov 2026.