HCCNCT05402644
Hepatectomy for Early-stage HCC Patients With CSPH
An observational study of HCC and Portal Hypertension, run by Tongji Hospital.
Trial summary
Clinically significant portal hypertension (CSPH) can affect the surgical prognosis of early-stage (BCLC stage A) HCC. An additional stage, such as the BCLC stage A-B, can be considered. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HCC, Portal Hypertension
- What is being tested?
- hepatectomy
- Type of treatment
- Surgery or procedure
- How many people
- 320 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2009to 1 Jan 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 311 HCC patients treated from December 2009 to January 2017.
Who may be able to join
- HCC was diagnosed by two experienced pathologists in Child-Pugh grade A/B negative resection margin Initial diagnosis of HCC in the patients
Who cannot join
- Distant transfer Not HCC
About this study
Official title: Clinically Significant Portal Hypertension (CSPH) on Early-stage HCC Following Hepatectomy: What's the Impact?
Clinically significant portal hypertension (CSPH) can affect the surgical prognosis of early-stage (BCLC stage A) HCC. An additional stage, such as the BCLC stage A-B, can be considered.
- Conditions
- HCC, Portal Hypertension
- Being tested
- hepatectomy
- Medical subject headings
- Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hepatectomyProcedure or surgery
Liver resection
| Study group | Role | What they receive |
|---|---|---|
| Non-CSPH | BCLC stage A patients who underwent hepatectomy in the group without clinically significant portal hypertension (Non-CSPH) Receives: Procedure: hepatectomy | |
| CSPH | BCLC stage A patients who underwent hepatectomy in the group with clinically significant portal hypertension (CSPH) Receives: Procedure: hepatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
death
Patient survival time after surgery
Measured: 2009--2025
recurrence
Patient recurrence time after surgery
Measured: 2009--2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start1 Dec 2009
- Primary completion1 Jan 2017
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCCStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe 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
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05402644
- Sponsor's protocol ID
- CXPJJH11800001-2018306
- Status last verified
- May 2021
- First submitted
- 26 May 2022
- Last updated
- 2 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinically Significant Portal Hypertension (CSPH) on Early-stage HCC Following Hepatectomy: What's the Impact?
- ClinicalTrials.gov ID
- NCT05402644
- Acronym / sponsor ID
- CXPJJH11800001-2018306
- Conditions
- HCC, Portal Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Dec 2009 (actual)
- Primary completion
- 1 Jan 2017 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 2 Jun 2022 (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.
Clinically significant portal hypertension (CSPH) can affect the surgical prognosis of early-stage (BCLC stage A) HCC. An additional stage, such as the BCLC stage A-B, can be considered.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-CSPH | – | Procedure: hepatectomyBCLC stage A patients who underwent hepatectomy in the group without clinically significant portal hypertension (Non-CSPH) |
| CSPH | – | Procedure: hepatectomyBCLC stage A patients who underwent hepatectomy in the group with clinically significant portal hypertension (CSPH) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 311 HCC patients treated from December 2009 to January 2017.
Key inclusion criteria (1 listed)
- HCC was diagnosed by two experienced pathologists in Child-Pugh grade A/B negative resection margin Initial diagnosis of HCC in the patients
Key exclusion criteria (1 listed)
- Distant transfer Not HCC
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 |
|---|---|---|
| hepatectomyLiver resection | Procedure or surgery | CSPH, Non-CSPH |
Primary outcome
death
Time frame: 2009--2025
Patient survival time after surgery
recurrence
Time frame: 2009--2025
Patient recurrence time after surgery
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 2 Jun 2022.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of HCC and Portal Hypertension, run by Tongji Hospital.
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 2 Jun 2022. 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?
death (time frame: 2009--2025). The study lists 2 primary outcomes in all. 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 2 Jun 2022.