Hepatocellular Carcinoma Stage IHCCNCT06390228
Impact of Hepatectomy on HCC Recurrence
An observational study of Hepatocellular Carcinoma Stage I and Recurrence, run by Anhui Medical University at 1 site in China.
Trial summary
Hepatectomy is the first option for the treatment of hepatocellular carcinoma(HCC) at CNLC Ib stage. HCC patients who undergo curative hepatectomy may experience varying remnant liver volumes and thus leads to different oncological outcomes. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hepatocellular Carcinoma Stage I, Recurrence
- What is being tested?
- Major hepatectomy
- Type of treatment
- Surgery or procedure
- How many people
- 197 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 1 Aug 2023
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: a final sample of 197 patients was included in this study. Among these patients, 70 underwent MAH (including 62 right hepatectomies, 4 extended right hepatectomies, and 4 extended left hepatectomies), while 127 patients underwent MIH (including 32 left hepatectomies, 10 right anterior hepatectomies, 17 right posterior hepatectomies, 11 mesohepatectomies, 20 left lateral hepatectomies, 21 right partial hepatectomies, 3 left partial hepatectomies, and 13 single segment hepatectomies). Using PSM analysis, 49 pairs of matched patients were identified from each group to compare outcomes.
Who may be able to join
- histologically confirmed solitary HCC with a size of ≥5 cm
- Eastern Cooperative Oncology Group score of 0 or 1
- preoperative indocyanine green retention rate at 15 minutes ≤15% and Child-Pugh A classification
- no evidence of vascular invasion or extrahepatic disease.
Who cannot join
- not diagnosed with HCC or had an HCC measuring <5 cm
- had confirmed tumor metastases or macrovascular invasion based on radiological examinations
- died within 90 days after surgery were excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Major Hepatectomy on Recurrence After Resection of Hepatocellular Carcinoma at China Liver Cancer Staging (CNLC) Stage : a Propensity Score Matching Study
Hepatectomy is the first option for the treatment of hepatocellular carcinoma(HCC) at CNLC Ib stage. HCC patients who undergo curative hepatectomy may experience varying remnant liver volumes and thus leads to different oncological outcomes.
Read the detailed description
Patients with hepatocellular carcinoma (HCC) who undergo curative hepatectomy may experience varying remnant liver volumes. The investigators aimed to evaluate whether the extent of liver resection has an effect on postoperative recurrence in HCC patients. A retrospective analysis was conducted on 197 patients who underwent hepatectomy for a solitary HCC lesion measuring ≥5 cm between January 2019 and June 2022. Patients were divided into major hepatectomy (MAH) group (n=70) and minor hepatectomy (MIH) group (n=127) based on the extent of liver resection. Recurrence-free survival (RFS) was compared between the two groups. Propensity score matching was employed to mitigate potential biases in this research.
- Conditions
- Hepatocellular Carcinoma Stage I, Recurrence
- Being tested
- Major hepatectomy
- Keywords
- Hepatocellular Carcinoma, recurrence, hepatectomy
- Medical subject headings
- Carcinoma, Hepatocellular, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Major hepatectomyProcedure or surgery
Also called minor hepatectomy
the extent of liver resection
| Study group | Role | What they receive |
|---|---|---|
| Major hepatectomy | Major hepatectomy was defined as the removal of four or more Couinaud's liver segments. Receives: Procedure: Major hepatectomy | |
| Minor hepatectomy | Minor hepatectomy was defined as the removal of three or fewer Couinaud's segments. |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence-free survival
the time from the time of radical surgery to the time of HCC recurrence
Measured: 2019.1-2023.8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start1 Jan 2019
- Primary completion1 Aug 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma Stage IStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anhui Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Responsible party
- Principal investigator, Kunyuan Jiang, Anhui Medical University
- Investigators
- Dalong Yin, Ph.D, Study director, The First Affiliated Hospital of University of Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06390228
- Sponsor's protocol ID
- 2023-RE-285
- Other IDs
- No. 82172071
- Acronym
- HCC
- Status last verified
- Apr 2024
- First submitted
- 24 Apr 2024
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Major Hepatectomy on Recurrence After Resection of Hepatocellular Carcinoma at China Liver Cancer Staging (CNLC) Stage : a Propensity Score Matching Study
- ClinicalTrials.gov ID
- NCT06390228
- Acronym / sponsor ID
- HCC / 2023-RE-285
- Conditions
- Hepatocellular Carcinoma Stage I, Recurrence
- Keywords
- Hepatocellular Carcinoma, recurrence, hepatectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- Anhui Medical UniversityUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 30 Apr 2024 (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.
Hepatectomy is the first option for the treatment of hepatocellular carcinoma(HCC) at CNLC Ib stage. HCC patients who undergo curative hepatectomy may experience varying remnant liver volumes and thus leads to different oncological outcomes.
Detailed description
Patients with hepatocellular carcinoma (HCC) who undergo curative hepatectomy may experience varying remnant liver volumes. The investigators aimed to evaluate whether the extent of liver resection has an effect on postoperative recurrence in HCC patients. A retrospective analysis was conducted on 197 patients who underwent hepatectomy for a solitary HCC lesion measuring ≥5 cm between January 2019 and June 2022. Patients were divided into major hepatectomy (MAH) group (n=70) and minor hepatectomy (MIH) group (n=127) based on the extent of liver resection. Recurrence-free survival (RFS) was compared between the two groups. Propensity score matching was employed to mitigate potential biases in this research.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Major hepatectomy | – | Procedure: Major hepatectomyMajor hepatectomy was defined as the removal of four or more Couinaud's liver segments. |
| Minor hepatectomy | – | –Minor hepatectomy was defined as the removal of three or fewer Couinaud's segments. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- a final sample of 197 patients was included in this study. Among these patients, 70 underwent MAH (including 62 right hepatectomies, 4 extended right hepatectomies, and 4 extended left hepatectomies), while 127 patients underwent MIH (including 32 left hepatectomies, 10 right anterior hepatectomies, 17 right posterior hepatectomies, 11 mesohepatectomies, 20 left lateral hepatectomies, 21 right partial hepatectomies, 3 left partial hepatectomies, and 13 single segment hepatectomies). Using PSM analysis, 49 pairs of matched patients were identified from each group to compare outcomes.
Key inclusion criteria (4 listed)
- histologically confirmed solitary HCC with a size of ≥5 cm
- Eastern Cooperative Oncology Group score of 0 or 1
- preoperative indocyanine green retention rate at 15 minutes ≤15% and Child-Pugh A classification
- no evidence of vascular invasion or extrahepatic disease.
Key exclusion criteria (3 listed)
- not diagnosed with HCC or had an HCC measuring <5 cm
- had confirmed tumor metastases or macrovascular invasion based on radiological examinations
- died within 90 days after surgery were excluded
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 |
|---|---|---|
| Major hepatectomyAlso: minor hepatectomythe extent of liver resection | Procedure or surgery | Major hepatectomy |
Primary outcome
recurrence-free survival
Time frame: 2019.1-2023.8
the time from the time of radical surgery to the time of HCC recurrence
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 30 Apr 2024.
- 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.
Dalong Yin, Ph.D study director
The First Affiliated Hospital of University of Science and Technology of China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma Stage I and Recurrence, run by Anhui Medical University at 1 site in China.
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 4 inclusion and 3 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 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
recurrence-free survival (time frame: 2019.1-2023.8). 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 30 Apr 2024.