Rupture, SpontaneousNCT03534843
A Comparison Between Child-Pugh and Albumin-Bilirubin Scores
An observational study of Rupture, Spontaneous and Rupture Liver, run by Huazhong University of Science and Technology.
Trial summary
To compare Child-Pugh and Albumin-Bilirubin scores in patients with spontaneous rupture of hepatocellular carcinoma 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?
- Liver resection and Transcatheter arterial embolization
- Type of treatment
- Surgery or procedure
- How many people
- 230 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2005to 1 Jan 2018
- 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 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.
Who may be able to join
- Be diagnosed as hepatocellular carcinoma pathologically; had a tumor rupture confirmed by Intraperitoneal exploration or clinical signs and symptoms in combination with imaging examination.
Who cannot join
- 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.
About this study
Official title: 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
Read the 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.
- Being tested
- Liver resection, Transcatheter arterial embolization
- Keywords
- Spontaneous rupture, survival, hepatocellular carcinoma, Child-Pugh, Albumin-bilirubin
- Medical subject headings
- Rupture, Spontaneous, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver resectionProcedure or surgery
Liver resection was comprised of single or multiple liver resections aiming to excise all macroscopic tumors.
Transcatheter arterial embolizationOther
Transcatheter arterial embolization or transcatheter arterial chemoembolization can localize the bleeding point and provide interventional embolization.
| Study group | Role | What they receive |
|---|---|---|
| Surgical treatment | Patients who received liver resection or palliative surgery, such as microwave coagulation therapy, hepatic artery ligation, or suturing ligation. Receives: Procedure: Liver resection | |
| Non-surgical treatment | Patients who received transcatheter arterial embolization (or transcatheter arterial chemoembolization) or conservative treatment Receives: Other: Transcatheter arterial embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival of all patients
Overall survival of all patients among different Child-Pugh and albumin-bilirubin scores
Measured: 5 years
Secondary outcomes (3)
Short-term mortality of all patients
Ninety-day mortality of all patients among different Child-Pugh and albumin-bilirubin scores
Measured: Ninety days
Short-term mortality of surgical subgroup
Ninety-day mortality of the surgical subgroup among different Child-Pugh and albumin-bilirubin scores
Measured: Ninety days
Short-term mortality of non-surgical subgroup
Ninety-day mortality of the non-surgical subgroup among different Child-Pugh and albumin-bilirubin scores
Measured: Ninety days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2018
- Study start1 Jan 2005
- Primary completion1 Aug 2015
- Study completion1 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 230 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, Prof. PHD, Study chair, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03534843
- Sponsor's protocol ID
- Chenxp011
- Status last verified
- May 2018
- First submitted
- 12 May 2018
- Last updated
- 29 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wu JJ, Zhang ZG, Zhu P, Mba'nbo-Koumpa AA, Zhang BX, Chen XP, Shu C, Zhang WG, Feng RJ, Li GX. Comparative liver function models for ruptured hepatocellular carcinoma: A 10-year single center experience. Asian J Surg. 2019 Sep;42(9):874-882. doi: 10.1016/j.asjsur.2018.12.015. Epub 2019 Jan 28.
PubMed 30704966
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Between Child-Pugh and Albumin-Bilirubin Scores in Patients With Spontaneous Rupture of Hepatocellular Carcinoma: A Retrospective Study
- ClinicalTrials.gov ID
- NCT03534843
- Acronym / sponsor ID
- Chenxp011
- Keywords
- Spontaneous rupture, survival, hepatocellular carcinoma, Child-Pugh, Albumin-bilirubin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Jan 2005 (actual)
- Primary completion
- 1 Aug 2015 (actual)
- Study completion
- 1 Jan 2018 (actual)
- First posted
- 23 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 compare Child-Pugh and Albumin-Bilirubin scores in patients with spontaneous rupture of hepatocellular carcinoma
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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical treatment | – | Procedure: Liver resectionPatients who received liver resection or palliative surgery, such as microwave coagulation therapy, hepatic artery ligation, or suturing ligation. |
| Non-surgical treatment | – | Other: Transcatheter arterial embolizationPatients who received transcatheter arterial embolization (or transcatheter arterial chemoembolization) or conservative treatment |
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 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.
Key inclusion criteria (1 listed)
- Be diagnosed as hepatocellular carcinoma pathologically; had a tumor rupture confirmed by Intraperitoneal exploration or clinical signs and symptoms in combination with imaging examination.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| Liver resectionLiver resection was comprised of single or multiple liver resections aiming to excise all macroscopic tumors. | Procedure or surgery | Surgical treatment |
| Transcatheter arterial embolizationTranscatheter arterial embolization or transcatheter arterial chemoembolization can localize the bleeding point and provide interventional embolization. | Other | Non-surgical treatment |
Primary outcome
Overall survival of all patients
Time frame: 5 years
Overall survival of all patients among different Child-Pugh and albumin-bilirubin scores
3 secondary outcomes
Short-term mortality of all patients
Time frame: Ninety days
Short-term mortality of surgical subgroup
Time frame: Ninety days
Short-term mortality of non-surgical subgroup
Time frame: Ninety days
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 29 May 2018.
- Derived from this study: PubMed 30704966Wu JJ, Zhang ZG, Zhu P, Mba'nbo-Koumpa AA, Zhang BX, Chen XP, Shu C, Zhang WG, Feng RJ, Li GX. Comparative liver function models for ruptured hepatocellular carcinoma: A 10-year single center experience. Asian J Surg. 2019 Sep;42(9):874-882. doi: 10.1016/j.asjsur.2018.12.015. Epub 2019 Jan 28.
- Individual participant dataSharing planned: Undecided
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RecruitingPhase 4
Latency Antibiotics in Previable PPROM, 18 0/7- 22 6/7 WGA
Rupture of Membranes; Delayed Delivery (Following Spontaneous Rupture), Rupture of Membranes; Premature
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, Prof. 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 29 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?
On the ClinicalTrials.gov record for NCT03534843, which also lists 1 linked publication.
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 29 May 2018.