Liver NeoplasmsNCT03045952
Percutaneous Microwave Ablation Under Ultrasound Guidance for Liver Cancer: a Multicenter Analysis
A study testing microwave ablation device in people with Liver Neoplasms, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
Ultrasound-guided percutaneous MWA of liver cancer is a relatively new technique with favorable long-term outcomes.Butthe results are mainly from single center reports.A larger scale data need to be analyzed to evaluate the technique. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Liver Neoplasms
- What is being tested?
- microwave ablation device
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,908 participants
- Where
- 1 siteChina
- Study dates
- Jan 2013to Dec 2020
- Phase
- Interventional
- 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
Who may be able to join
- absence of ascites or the depth of ascites on US detection less than 4 cm;
- a normal serum total bilirubin level or less than 60 µmol/L;
- a normal albumin level or not less than 30 g/L;
- for radical treatment, single lesion of 8 cm or smaller, three or fewer multiple lesions with a maximum diameter of 4 cm or less, absence of portal vein cancerous thrombus or extrahepatic metastases;
- for palliative treatment, those with large or multiple lesions, suffering multiple metastases and unsuitable for other modalities can be considered to undergo the MWA on the condition of good hepatic function and blood coagulation function to tolerate the procedure.
Who cannot join
- Contraindications include patients who have
- clinical evident liver failure, such as massive ascites or hepatic encephalopathy or with a trance-like state;
- severe blood coagulation dysfunction (prothrombin time of more than 30 seconds, prothrombin activity less than 40%, and platelet count less than 30 cells×109/L);
- high intrahepatic tumor burden (tumor volume >70% of the target liver volume or multiple tumor nodules) or high extrahepatic tumor burden;
- acute or active inflammatory and infectious lesions at any organ;
- acute or severe chronic renal failure, pulmonary insufficiency or heart dysfunction;
- relative contraindication concerns medical risk for the tumor proximity to diaphragm, gastrointestinal tract, gallbladder, pancreas, hepatic hilum and major bile duct or vessels, which may require adjunctive techniques to prevent off-target heating of adjacent structures during the ablation procedure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Percutaneous Microwave Ablation Under Ultrasound Guidance for Primary Liver Cancer: a Multicenter Analysis
Ultrasound-guided percutaneous MWA of liver cancer is a relatively new technique with favorable long-term outcomes.Butthe results are mainly from single center reports.A larger scale data need to be analyzed to evaluate the technique. This study is designed to investigated the efficacy of cooled-tip microwave ablation (MWA) for primary liver cancer (PLC) and analyzed the prognostic factors on a multicenter database.Between January 2013 and December 2018, all the PLC patients underwent ultrasound-guided percutaneous cooled-tip MWA as a primary treatment will be enrolled from at least ten Chinese institutions with different levels of MWA experience. All the patients will be closely followed up until June 2019. Clinicopathologic data, recurrence and survival estimates, complications and prognosis-relative factors will be measured.
- Conditions
- Liver Neoplasms
- Being tested
- microwave ablation device
- Keywords
- Multicenter study, microwave
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microwave ablation deviceProcedure or surgery
Microwave ablation is a technique that uses thermal therapy to induce complete necrosis of tumor in situ by using microwave ablation device.
| Study group | Role | What they receive |
|---|---|---|
| microwave ablation | Experimental | Antenna in the microwave ablation device was percutaneously inserted into the tumor and placed at designated place under US guidance. For tumors less than 1.5 cm, one antenna was inserted and for tumors measuring 1.5 cm or greater, two antennae were inserted in parallel with an inter-antenna distance of 1.0-2.5 cm, which were used simultaneously during MWA to obtain larger ablation zone. A 20G thermocouple was inserted about 0.5-1 cm away from the tumor for real-time temperature monitoring during MWA. MW emission didn't stop until the heat-generated hyperechoic water vapor completely encompassed the entire tumor and the measured temperature reached 60°C or remained above 54°C for at least three minutes. Receives: Procedure: microwave ablation device |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Measured: 5 years
Secondary outcomes (5)
intrahepatic metastasis
Measured: 5 years
extrahepatic metastasis
Measured: 5 years
local tumor progress
Measured: 5 years
complication
number of participants with side effect and major complication
Measured: 1 month
disease free survival
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 posted8 Feb 2017 (estimated)
- Study startJan 2013
- Primary completionDec 2019
- Study completionDec 2020
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 NeoplasmsStudies of the same condition, open and under way.
- More trials run by Chinese PLA General 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,908 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ping Liang, Chinese PLA General Hospital
- Investigators
- Ping Liang, Dr., Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03045952
- Sponsor's protocol ID
- 66939530lp
- Status last verified
- Mar 2021
- First submitted
- 26 Dec 2016
- Last updated
- 4 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Cai Q, Pang C, Wang Z, Li J, Dai Y, Fan FY, Wang ZQ, Hu X, Li L, Chen XW, Ji R, Mei Q, Zhang C, Liang P, Yu X, Liu FY, Cheng Z, Yu J. Relationship between postablation fever and prognosis in initial hepatocellular carcinoma: a 15-year multicenter, retrospective cohort study. Int J Surg. 2025 Jan 1;111(1):962-971. doi: 10.1097/JS9.0000000000002066.
PubMed 39291970
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Microwave Ablation Under Ultrasound Guidance for Primary Liver Cancer: a Multicenter Analysis
- ClinicalTrials.gov ID
- NCT03045952
- Acronym / sponsor ID
- 66939530lp
- Conditions
- Liver Neoplasms
- Keywords
- Multicenter study, microwave
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,908 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 8 Feb 2017 (estimated)
- 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.
Ultrasound-guided percutaneous MWA of liver cancer is a relatively new technique with favorable long-term outcomes.Butthe results are mainly from single center reports.A larger scale data need to be analyzed to evaluate the technique. This study is designed to investigated the efficacy of cooled-tip microwave ablation (MWA) for primary liver cancer (PLC) and analyzed the prognostic factors on a multicenter database.Between January 2013 and December 2018, all the PLC patients underwent ultrasound-guided percutaneous cooled-tip MWA as a primary treatment will be enrolled from at least ten Chinese institutions with different levels of MWA experience. All the patients will be closely followed up until June 2019. Clinicopathologic data, recurrence and survival estimates, complications and prognosis-relative factors will be measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| microwave ablation | Experimental | Procedure: microwave ablation deviceAntenna in the microwave ablation device was percutaneously inserted into the tumor and placed at designated place under US guidance. For tumors less than 1.5 cm, one antenna was inserted and for tumors measuring 1.5 cm or greater, two antennae were inserted in parallel with an inter-antenna distance of 1.0-2.5 cm, which were used simultaneously during MWA to obtain larger ablation zone. A 20G thermocouple was inserted about 0.5-1 cm away from the tumor for real-time temperature monitoring during MWA. MW emission didn't stop until the heat-generated hyperechoic water vapor completely encompassed the entire tumor and the measured temperature reached 60°C or remained above 54°C for at least three minutes. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- absence of ascites or the depth of ascites on US detection less than 4 cm;
- a normal serum total bilirubin level or less than 60 µmol/L;
- a normal albumin level or not less than 30 g/L;
- for radical treatment, single lesion of 8 cm or smaller, three or fewer multiple lesions with a maximum diameter of 4 cm or less, absence of portal vein cancerous thrombus or extrahepatic metastases;
- for palliative treatment, those with large or multiple lesions, suffering multiple metastases and unsuitable for other modalities can be considered to undergo the MWA on the condition of good hepatic function and blood coagulation function to tolerate the procedure.
Key exclusion criteria (7 listed)
- Contraindications include patients who have
- clinical evident liver failure, such as massive ascites or hepatic encephalopathy or with a trance-like state;
- severe blood coagulation dysfunction (prothrombin time of more than 30 seconds, prothrombin activity less than 40%, and platelet count less than 30 cells×109/L);
- high intrahepatic tumor burden (tumor volume >70% of the target liver volume or multiple tumor nodules) or high extrahepatic tumor burden;
- acute or active inflammatory and infectious lesions at any organ;
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 |
|---|---|---|
| microwave ablation deviceMicrowave ablation is a technique that uses thermal therapy to induce complete necrosis of tumor in situ by using microwave ablation device. | Procedure or surgery | microwave ablation |
Primary outcome
overall survival
Time frame: 5 years
5 secondary outcomes
intrahepatic metastasis
Time frame: 5 years
extrahepatic metastasis
Time frame: 5 years
local tumor progress
Time frame: 5 years
complication
Time frame: 1 month
disease free survival
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 Mar 2021.
- Derived from this study: PubMed 39291970Cai Q, Pang C, Wang Z, Li J, Dai Y, Fan FY, Wang ZQ, Hu X, Li L, Chen XW, Ji R, Mei Q, Zhang C, Liang P, Yu X, Liu FY, Cheng Z, Yu J. Relationship between postablation fever and prognosis in initial hepatocellular carcinoma: a 15-year multicenter, retrospective cohort study. Int J Surg. 2025 Jan 1;111(1):962-971. doi: 10.1097/JS9.0000000000002066.
- 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.
Ping Liang, Dr. principal investigator
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing microwave ablation device in people with Liver Neoplasms, run by Chinese PLA General Hospital 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 5 inclusion and 7 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 Mar 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?
overall survival (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 NCT03045952, 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 4 Mar 2021.