Liver CancerNCT04413526
Radiofrequency-assisted Liver Resection in Intractable Liver Cancer
An observational study of Liver Cancer, run by Hepatopancreatobiliary Surgery Institute of Gansu Province at 1 site in China.
Trial summary
In this retrospective study, the investigators assessed the application of radiofrequency-assisted liver resection in intractable liver cancer resection, and plan to analysis the different factors. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Liver Cancer
- What is being tested?
- radiofrequency, TACE and TACE+radiofrequency
- Type of treatment
- Surgery or procedure
- How many people
- 199 participants
- Where
- 1 siteChina
- Study dates
- 25 May 2020to 18 Nov 2021
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HCC patients
Who may be able to join
- Ultrasound-guided fine-needle aspiration pathology or postoperative pathology was confirmed to be liver cancer, no pathological results according to China 's 2017 version of the hepatocarcinoma (HCC) diagnosis and treatment specifications, in line with the standard clinical diagnosis of liver cancer
- According to Barcelona Clinic Liver Cancer (BCLC) staging criteria, it is stage C (stage C: single tumour> 5 cm or more than three tumours, and at least one tumour> 3 cm, liver function Child-Pugh A or B, with lymph node metastasis or distant metastasis or portal vein or Venous liver trunk is invaded, penance Status (PST) score 1-2 points)
Who cannot join
- HCC patients with other malignant tumours
- Metastatic liver tumour
- Patients with liver abscess
- Patients with organ dysfunction
Trial locations and contacts
1 site in 1 country.
China1 site
Hepatopancreatobiliary Surgery Institute of Gansu Province
Lanzhou, Gansu, 730000
About this study
Official title: The Application of Radiofrequency-assisted Liver Resection in Intractable Liver Cancer
In this retrospective study, the investigators assessed the application of radiofrequency-assisted liver resection in intractable liver cancer resection, and plan to analysis the different factors.
Read the detailed description
The primary clinical treatment of liver cancer is surgical resection, although many integrated applications develop rapidly, surgery is still the best way to remove the tumour lesion. Traditional ways that have curative removed tumours in three methods, which are liver resection, liver transplantation and radiofrequency ablation (RFA).
As for primary liver cancer, surgery, and RFA are both effective and safety, but for the complexity of end-stage liver cancer, surgical resection may not remove the tumours alone. Surgical resection with radiofrequency ablation therapy for intractable liver cancer is a kind of active plan. The therapy can eliminate the tumour, maximize the protection of patient liver tissue, reduce operation damage, reduce the incidence of complications, and improve patients quality of life after surgery.
- Conditions
- Liver Cancer
- Being tested
- radiofrequency, TACE, TACE+radiofrequency
- Keywords
- RFA, liver cancer, surgical resection
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiofrequencyProcedure or surgery
radiofrequency combined with liver resection
TACEProcedure or surgery
only TACE treatment
TACE+radiofrequencyProcedure or surgery
TACE followed by radiofrequency
| Study group | Role | What they receive |
|---|---|---|
| radiofrequency-assisted liver resection | radiofrequency-assisted liver resection for intractable liver cancer Receives: Procedure: radiofrequency | |
| TACE(transcatheter arterial chemoembolization) | temporary TACE for intractable liver cancer Receives: Procedure: TACE | |
| radiofrequency ablation plus TACE | radiofrequency ablation plus TACE for intractable liver cancer Receives: Procedure: TACE+radiofrequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
The survival rates for one-year to five-year
The survival rates was defined as the percentage of liver cancer for five years.
Measured: 5 years
Secondary outcomes (2)
The hospital stay
The length of stay in a hospital regarding days
Measured: 3 months
The Child-Pugh score after therapy
The Child-Pugh is based on the presence and severity of ascites and hepatic encephalopathy, the prolongation of prothrombin time, and the levels of serum bilirubin and albumin. According to the Child-Pugh scores, patients are classified into three classes (Child class A, B, and C with CP scores 5-6, 7-9, and 10-15, respectively)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start25 May 2020
- Primary completion18 Nov 2021
- Study completion18 Nov 2021
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 Liver CancerStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hepatopancreatobiliary Surgery Institute of Gansu Province
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wenbo Meng, Hepatopancreatobiliary Surgery Institute of Gansu Province
- Investigators
- Wenbo Meng, M.D., Ph. D., Principal investigator, Hepatopancreatobiliary Surgery Institute of Gansu Province
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04413526
- Sponsor's protocol ID
- radiofrequency liver resection
- Status last verified
- Nov 2021
- First submitted
- 25 May 2020
- Last updated
- 19 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sun Y, Ji S, Ji H, Liu L, Li C. Clinical efficacy analysis of transcatheter arterial chemoembolization (TACE) combined with radiofrequency ablation (RFA) in primary liver cancer and recurrent liver cancer. J BUON. 2019 Jul-Aug;24(4):1402-1407.
PubMed 31646783
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of Radiofrequency-assisted Liver Resection in Intractable Liver Cancer
- ClinicalTrials.gov ID
- NCT04413526
- Acronym / sponsor ID
- radiofrequency liver resection
- Conditions
- Liver Cancer
- Keywords
- RFA, liver cancer, surgical resection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- Hepatopancreatobiliary Surgery Institute of Gansu ProvinceUniversity, hospital or other
- Study start
- 25 May 2020 (actual)
- Primary completion
- 18 Nov 2021 (actual)
- Study completion
- 18 Nov 2021 (actual)
- First posted
- 4 Jun 2020 (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.
In this retrospective study, the investigators assessed the application of radiofrequency-assisted liver resection in intractable liver cancer resection, and plan to analysis the different factors.
Detailed description
The primary clinical treatment of liver cancer is surgical resection, although many integrated applications develop rapidly, surgery is still the best way to remove the tumour lesion. Traditional ways that have curative removed tumours in three methods, which are liver resection, liver transplantation and radiofrequency ablation (RFA).
As for primary liver cancer, surgery, and RFA are both effective and safety, but for the complexity of end-stage liver cancer, surgical resection may not remove the tumours alone. Surgical resection with radiofrequency ablation therapy for intractable liver cancer is a kind of active plan. The therapy can eliminate the tumour, maximize the protection of patient liver tissue, reduce operation damage, reduce the incidence of complications, and improve patients quality of life after surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| radiofrequency-assisted liver resection | – | Procedure: radiofrequencyradiofrequency-assisted liver resection for intractable liver cancer |
| TACE(transcatheter arterial chemoembolization) | – | Procedure: TACEtemporary TACE for intractable liver cancer |
| radiofrequency ablation plus TACE | – | Procedure: TACE+radiofrequencyradiofrequency ablation plus TACE for intractable liver cancer |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HCC patients
Key inclusion criteria (2 listed)
- Ultrasound-guided fine-needle aspiration pathology or postoperative pathology was confirmed to be liver cancer, no pathological results according to China 's 2017 version of the hepatocarcinoma (HCC) diagnosis and treatment specifications, in line with the standard clinical diagnosis of liver cancer
- According to Barcelona Clinic Liver Cancer (BCLC) staging criteria, it is stage C (stage C: single tumour> 5 cm or more than three tumours, and at least one tumour> 3 cm, liver function Child-Pugh A or B, with lymph node metastasis or distant metastasis or portal vein or Venous liver trunk is invaded, penance Status (PST) score 1-2 points)
Key exclusion criteria (4 listed)
- HCC patients with other malignant tumours
- Metastatic liver tumour
- Patients with liver abscess
- Patients with organ dysfunction
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 |
|---|---|---|
| radiofrequencyradiofrequency combined with liver resection | Procedure or surgery | radiofrequency-assisted liver resection |
| TACEonly TACE treatment | Procedure or surgery | TACE(transcatheter arterial chemoembolization) |
| TACE+radiofrequencyTACE followed by radiofrequency | Procedure or surgery | radiofrequency ablation plus TACE |
Primary outcome
The survival rates for one-year to five-year
Time frame: 5 years
The survival rates was defined as the percentage of liver cancer for five years.
2 secondary outcomes
The hospital stay
Time frame: 3 months
The Child-Pugh score after therapy
Time frame: 3 months
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 19 Nov 2021.
- Background: PubMed 31646783Sun Y, Ji S, Ji H, Liu L, Li C. Clinical efficacy analysis of transcatheter arterial chemoembolization (TACE) combined with radiofrequency ablation (RFA) in primary liver cancer and recurrent liver cancer. J BUON. 2019 Jul-Aug;24(4):1402-1407.
- Individual participant dataSharing planned: No
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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.
Wenbo Meng, M.D., Ph. D. principal investigator
Hepatopancreatobiliary Surgery Institute of Gansu Province
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 Liver Cancer, run by Hepatopancreatobiliary Surgery Institute of Gansu Province 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 2 inclusion and 4 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 19 Nov 2021. 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?
The survival rates for one-year to five-year (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 NCT04413526, 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 19 Nov 2021.