Hepatocellular CarcinomaNCT04365751
To Compare the Efficacy of Microwave Ablation and Laparoscopic Hepatectomy for Hepatocellular Carcinoma
A study testing Percutaneous microwave ablation, Laparoscopic hepatectomy in people with Hepatocellular Carcinoma, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
The study was a prospective multicenter cohort control study, which was divided into 1:1 groups to compare the clinical efficacy of percutaneous microwave ablation and laparoscopic hepatocellular carcinoma resection (tumor diameter 3.1-5.0cm). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Percutaneous microwave ablation, Laparoscopic hepatectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,134 participants
- Where
- 1 siteChina
- Study dates
- 26 Dec 2019to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.Older than 18 years old, regardless of gender; 2.In patients without cirrhosis background, hepatocellular carcinoma was definitely pathologically diagnosed within 1 month before surgery. In patients with cirrhosis background, dynamic contrast enhanced MRI/ multi-stage dynamic enhanced CT were used to determine the characteristic vascular signs of primary liver cancer (rapid heterogeneous vascular enhancement in arterial phase, rapid elution in venous phase or delayed phase); 3.The number of tumors was ≤3, and the maximum diameter of at least one tumor was 3.1-5.0cm; 4.No vascular and lymph node invasion and distant metastasis; 5.Liver function: child-pugh A or B (assessed within 14 days before surgery); 6.Subjects will understand the purpose of the study, voluntarily participate and sign the informed consent.
Who cannot join
- 1.Severe hepatic decompensation, presence of hepatic encephalopathy, massive ascites or gastrointestinal bleeding within 1 month; 2.Clotting disorders or bleeding tendencies (platelet count \<50 x 109 / L or INR\>1.5); 3.Patients with severe cardiac, pulmonary and renal insufficiency; 4.Combined with active infection; 5.Pregnant patients; 6.A history of drug abuse and mental illness; 7.Inability to tolerate pneumoperitoneum; 8.Other studies or anti-tumor therapists in the first four weeks of the study; 9.The researchers determined that there were any other factors that were inappropriate for inclusion or that affected participants' participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Jie Yu, Doctor, 8601066939530, yu-jie301@hotmail.com
About this study
Official title: A Prospective Multicenter Cohort Control Study of Percutaneous Microwave Ablation and Laparoscopic Resection for Hepatocellular Carcinoma With a Diameter of 3.1 ~ 5.0cm
The study was a prospective multicenter cohort control study, which was divided into 1:1 groups to compare the clinical efficacy of percutaneous microwave ablation and laparoscopic hepatocellular carcinoma resection (tumor diameter 3.1-5.0cm).
Read the detailed description
Research objectives:
To compare the clinical efficacy of percutaneous microwave ablation and laparoscopic resection for hepatocellular carcinoma (tumor diameter 3.1-5.0cm).
Research background:
Liver cancer is the sixth most common tumor in the world and the second leading cause of death. Due to the hepatitis B epidemic, the incidence of liver cancer in China is very high, accounting for about half of the global statistics on the number of new liver cancer cases and deaths each year. Current treatment guidelines recommend surgical resection or transplantation as the gold standard for the treatment of very early or early HCC patients. Meanwhile, local ablation is gradually accepted by clinicians for its minimally invasive nature, safety and efficacy, and it is recommended as an alternative treatment for tumors within 3cm. However, the choice of treatment for 3.1-5cm HCC based on a number of current retrospective studies is controversial. Therefore, we designed this study to provide reliable prospective data to support the selection of therapeutic modalities for HCC.
Technical introduction:
Microwave ablation (MWA) is an ultrasound guided ablation electrode implanted in the target tissue, in the form of electromagnetic waves to generate microwave energy, microwave can make the surrounding tissue in the water molecules oscillate against the friction of heat, high temperature heat causes rapid coagulation necrosis of the tissue, so as to achieve the purpose of local tumor treatment. Compared with other ablation techniques, MWA in the treatment of solid tumors can achieve higher tumor internal temperature in a shorter period of time, with strong penetration, synergistic effect of multi-needle combined ablation, and little influence by carbonization and blood perfusion. Therefore, MWA has fast heat production, high intracellular temperature, short ablation time and large ablation range.
Laparoscopic liver resection (Laparoscopic hepatectomy) reported for the first time in 1991 by the professor Reich. Laparoscopic techniques in the application in benign (malignant) liver disease is widespread. In China, since professor Weiping Zhou and others completed the first laparoscopic liver resection in mainland China in 1994, there have been continuous literature reports, and the scope and difficulty of surgical resection have been increasing.The 2008 Louisville declaration states that laparoscopic liver surgery is safe and effective for surgeons with extensive experience in hepatobiliary surgery and laparoscopic surgery.
Research methods In this study, 1134 patients were expected to be enrolled according to the 1:1 grouping of the experimental group and the control group. The efficacy of the two treatment methods was evaluated by comparing the overall survival of the two groups and other indicators.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Percutaneous microwave ablation, Laparoscopic hepatectomy
- Keywords
- microwave ablation, hepatocellular carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous microwave ablation, Laparoscopic hepatectomyProcedure or surgery
For patients with hepatocellular carcinoma who meet the enrollment requirements, under the guidance of ultrasound, microwave ablation electrodes were implanted into the tumor tissues by percutaneous puncture, and the high-temperature heat energy was generated to cause coagulation necrosis of the tumor, so as to achieve the goal of local tumor treatment with minimally invasive technology.
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous microwave ablation group | Experimental | MWA (Microwave) is an ultrasound-guided, minimally invasive technique that implants ablation electrodes into target tissue to rapidly generate high temperatures and rapidly develop coagulative necrosis in tumor tissue, thereby achieving the goal of local tumor treatment. Receives: Procedure: Percutaneous microwave ablation, Laparoscopic hepatectomy |
| Laparoscopic hepatectomy | Other | Laparoscopic hepatectomy is a widely used surgical technique in the treatment of benign (malignant) liver diseases Receives: Procedure: Percutaneous microwave ablation, Laparoscopic hepatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Defined as the length of time from the beginning of treatment to death or the last follow-up (if no death).
Measured: 60 months
Secondary outcomes (4)
Progression-free survival
Defined as the period of time between the time the patient is treated and the time the disease progresses or death from any cause is observed
Measured: 60 months
Intrahepatic recurrence rate
Defined as the proportion of patients with intrahepatic recurrence from the beginning of the study to the end of the study or the death of the patients
Measured: 60 months
Rate of extrahepatic metastasis
Defined as the proportion of cases with extrahepatic metastasis from the beginning of the study to the end of the study or the death of the patient
Measured: 60 months
Local rate of progression
Defined as the proportion of patients with active tumor at the edge of the treatment area during follow-up after the tumor was completely treated
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start26 Dec 2019
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,134 participants (estimated)
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, Doctor, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04365751
- Sponsor's protocol ID
- 2019002
- Status last verified
- Apr 2020
- First submitted
- 24 Apr 2020
- Last updated
- 28 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Cohort Control Study of Percutaneous Microwave Ablation and Laparoscopic Resection for Hepatocellular Carcinoma With a Diameter of 3.1 ~ 5.0cm
- ClinicalTrials.gov ID
- NCT04365751
- Acronym / sponsor ID
- 2019002
- Conditions
- Hepatocellular Carcinoma
- Keywords
- microwave ablation, hepatocellular carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,134 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 26 Dec 2019 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 28 Apr 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.
The study was a prospective multicenter cohort control study, which was divided into 1:1 groups to compare the clinical efficacy of percutaneous microwave ablation and laparoscopic hepatocellular carcinoma resection (tumor diameter 3.1-5.0cm).
Detailed description
Research objectives:
To compare the clinical efficacy of percutaneous microwave ablation and laparoscopic resection for hepatocellular carcinoma (tumor diameter 3.1-5.0cm).
Research background:
Liver cancer is the sixth most common tumor in the world and the second leading cause of death. Due to the hepatitis B epidemic, the incidence of liver cancer in China is very high, accounting for about half of the global statistics on the number of new liver cancer cases and deaths each year. Current treatment guidelines recommend surgical resection or transplantation as the gold standard for the treatment of very early or early HCC patients. Meanwhile, local ablation is gradually accepted by clinicians for its minimally invasive nature, safety and efficacy, and it is recommended as an alternative treatment for tumors within 3cm. However, the choice of treatment for 3.1-5cm HCC based on a number of current retrospective studies is controversial. Therefore, we designed this study to provide reliable prospective data to support the selection of therapeutic modalities for HCC.
Technical introduction:
Microwave ablation (MWA) is an ultrasound guided ablation electrode implanted in the target tissue, in the form of electromagnetic waves to generate microwave energy, microwave can make the surrounding tissue in the water molecules oscillate against the friction of heat, high temperature heat causes rapid coagulation necrosis of the tissue, so as to achieve the purpose of local tumor treatment. Compared with other ablation techniques, MWA in the treatment of solid tumors can achieve higher tumor internal temperature in a shorter period of time, with strong penetration, synergistic effect of multi-needle combined ablation, and little influence by carbonization and blood perfusion. Therefore, MWA has fast heat production, high intracellular temperature, short ablation time and large ablation range.
Laparoscopic liver resection (Laparoscopic hepatectomy) reported for the first time in 1991 by the professor Reich. Laparoscopic techniques in the application in benign (malignant) liver disease is widespread. In China, since professor Weiping Zhou and others completed the first laparoscopic liver resection in mainland China in 1994, there have been continuous literature reports, and the scope and difficulty of surgical resection have been increasing.The 2008 Louisville declaration states that laparoscopic liver surgery is safe and effective for surgeons with extensive experience in hepatobiliary surgery and laparoscopic surgery.
Research methods In this study, 1134 patients were expected to be enrolled according to the 1:1 grouping of the experimental group and the control group. The efficacy of the two treatment methods was evaluated by comparing the overall survival of the two groups and other indicators.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Percutaneous microwave ablation group | Experimental | Procedure: Percutaneous microwave ablation, Laparoscopic hepatectomyMWA (Microwave) is an ultrasound-guided, minimally invasive technique that implants ablation electrodes into target tissue to rapidly generate high temperatures and rapidly develop coagulative necrosis in tumor tissue, thereby achieving the goal of local tumor treatment. |
| Laparoscopic hepatectomy | Other | Procedure: Percutaneous microwave ablation, Laparoscopic hepatectomyLaparoscopic hepatectomy is a widely used surgical technique in the treatment of benign (malignant) liver diseases |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1.Older than 18 years old, regardless of gender; 2.In patients without cirrhosis background, hepatocellular carcinoma was definitely pathologically diagnosed within 1 month before surgery. In patients with cirrhosis background, dynamic contrast enhanced MRI/ multi-stage dynamic enhanced CT were used to determine the characteristic vascular signs of primary liver cancer (rapid heterogeneous vascular enhancement in arterial phase, rapid elution in venous phase or delayed phase); 3.The number of tumors was ≤3, and the maximum diameter of at least one tumor was 3.1-5.0cm; 4.No vascular and lymph node invasion and distant metastasis; 5.Liver function: child-pugh A or B (assessed within 14 days before surgery); 6.Subjects will understand the purpose of the study, voluntarily participate and sign the informed consent.
Key exclusion criteria (1 listed)
- 1.Severe hepatic decompensation, presence of hepatic encephalopathy, massive ascites or gastrointestinal bleeding within 1 month; 2.Clotting disorders or bleeding tendencies (platelet count \<50 x 109 / L or INR\>1.5); 3.Patients with severe cardiac, pulmonary and renal insufficiency; 4.Combined with active infection; 5.Pregnant patients; 6.A history of drug abuse and mental illness; 7.Inability to tolerate pneumoperitoneum; 8.Other studies or anti-tumor therapists in the first four weeks of the study; 9.The researchers determined that there were any other factors that were inappropriate for inclusion or that affected participants' participation in the study.
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 |
|---|---|---|
| Percutaneous microwave ablation, Laparoscopic hepatectomyFor patients with hepatocellular carcinoma who meet the enrollment requirements, under the guidance of ultrasound, microwave ablation electrodes were implanted into the tumor tissues by percutaneous puncture, and the high-temperature heat energy was generated to cause coagulation necrosis of the tumor, so as to achieve the goal of local tumor treatment with minimally invasive technology. | Procedure or surgery | Laparoscopic hepatectomy, Percutaneous microwave ablation group |
Primary outcome
Overall survival
Time frame: 60 months
Defined as the length of time from the beginning of treatment to death or the last follow-up (if no death).
4 secondary outcomes
Progression-free survival
Time frame: 60 months
Intrahepatic recurrence rate
Time frame: 60 months
Rate of extrahepatic metastasis
Time frame: 60 months
Local rate of progression
Time frame: 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2020.
- 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.
Ping Liang, Doctor 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 Percutaneous microwave ablation, Laparoscopic hepatectomy in people with Hepatocellular Carcinoma, 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 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: looking for participants now, as of the sponsor's last update on 28 Apr 2020. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jie Yu, Doctor (8601066939530, jiemi301@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 60 months). 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 28 Apr 2020.