Hepatocellular Carcinoma (HCC)NCT07748481
Comparison of the Therapeutic Efficacy of Non-touch Microwave Ablation, Tumor-puncture Microwave Ablation and Surgical Resection for Subcapsular Hepatocellular Carcinoma
An observational study of Hepatocellular Carcinoma (HCC), run by The First Hospital of Jilin University.
Trial summary
Subcapsular hepatocellular carcinoma (HCC) has unique anatomical characteristics that may influence treatment selection and clinical outcomes. Surgical resection and liver transplantation are potentially curative treatments but may be limited by liver function, tumor characteristics, and perioperative risks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma (HCC)
- What is being tested?
- No-touch Microwave Ablation, Tumor-puncture Microwave Ablation and Surgical Resection
- Type of treatment
- Surgery or procedure
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 May 2029
- Phase
- Observational
- 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
Study population: The study population will consist of adult patients with confirmed subcapsular hepatocellular carcinoma (HCC) who receive no-touch microwave ablation, tumor-puncture microwave ablation, or surgical resection as part of routine clinical practice. The diagnosis of HCC will be established according to the practice guidelines of the American Association for the Study of Liver Diseases (AASLD). Subcapsular HCC will be defined based on imaging findings, with the shortest distance between the tumor margin and the liver capsule being ≤3 mm as confirmed by ultrasound, computed tomography (CT), or magnetic resonance imaging (MRI). Eligible patients will be prospectively enrolled and followed to evaluate treatment efficacy, safety, recurrence patterns, and long-term survival outcomes.
Who may be able to join
- Diagnosed with hepatocellular carcinoma (HCC) confirmed by pathological biopsy or clinical diagnostic criteria; Imaging examinations including ultrasound confirm that the HCC lesion is subcapsular, defined as the minimum distance between the tumor and liver capsule ≤ 3 mm; Single tumor with maximum diameter ≤ 5 cm, or up to 3 multiple tumors each with maximum diameter ≤ 3 cm; Liver function classified as Child-Pugh grade A or B; No invasion of adjacent blood vessels or vital organs; no tumor thrombus in the main portal vein or hepatic vein, and no extrahepatic metastasis.
- Exclusion Criteria:Patients with dysfunction of vital organs such as heart and lungs; Patients who received preoperative radiotherapy, chemotherapy, targeted therapy or immunotherapy, or patients complicated with other malignant tumors; Poor follow-up compliance and inability to complete the standardized follow-up procedures.
- -
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Subcapsular hepatocellular carcinoma (HCC) has unique anatomical characteristics that may influence treatment selection and clinical outcomes. Surgical resection and liver transplantation are potentially curative treatments but may be limited by liver function, tumor characteristics, and perioperative risks. Microwave ablation has become an important minimally invasive treatment option for patients with HCC, particularly for lesions that are difficult to treat surgically. This prospective observational cohort study aims to compare the therapeutic efficacy, safety, and long-term outcomes of no-touch microwave ablation, tumor-puncture microwave ablation and surgical resection in patients with subcapsular HCC. Treatment outcomes, including local tumor control, treatment-related complications, recurrence, and survival outcomes, will be evaluated to provide evidence for individualized treatment strategies for patients with subcapsular HCC.
Read the detailed description
This single-center prospective observational cohort study will be conducted at the First Hospital of Jilin University. The study aims to evaluate and compare the therapeutic efficacy, safety, and long-term clinical outcomes of three treatment modalities, including no-touch microwave ablation, tumor-puncture microwave ablation, and surgical resection, in patients with subcapsular hepatocellular carcinoma (HCC). The study will compare local tumor control, recurrence patterns, treatment-related complications, and survival outcomes among the three groups, providing clinical evidence for individualized treatment selection and optimizing long-term management strategies for patients with subcapsular HCC. The study population will consist of patients with a confirmed diagnosis of hepatocellular carcinoma. The diagnosis of HCC will be based on the practice guidelines of the American Association for the Study of Liver Diseases (AASLD). The definition of subcapsular hepatocellular carcinoma will follow previously published criteria, in which the shortest distance between the tumor margin and the liver capsule is ≤3 mm, as confirmed by imaging examinations including ultrasound, computed tomography (CT), or magnetic resonance imaging (MRI). All enrolled patients will undergo comprehensive pre-treatment evaluations according to standard clinical practice, including routine blood tests, liver and renal function tests, coagulation assessment, serum alpha-fetoprotein (AFP) measurement, conventional ultrasound combined with contrast-enhanced ultrasound, and contrast-enhanced CT or MRI. These examinations will be used to assess tumor characteristics, hepatic functional reserve, and overall physical condition. Treatment strategies will be determined by a multidisciplinary liver cancer team based on clinical evaluation and patient-specific factors. All microwave ablation procedures will be performed by experienced interventional ultrasound physicians with more than 10 years of experience in microwave ablation therapy. During the study period, treatment responses and prognostic outcomes will be evaluated through follow-up assessments. Short-term follow-up data will include hospitalization duration and the incidence of postoperative complications, including hemorrhage, infection, needle tract seeding, thermal injury to perihepatic structures, liver failure, and ascites. Long-term therapeutic outcomes will be evaluated according to the following criteria: 1. Local tumor control rate: Patients will undergo regular imaging follow-up to evaluate local tumor recurrence. Local recurrence will be defined as the appearance of viable tumor lesions within or adjacent to the ablation zone in the microwave ablation groups, or recurrence near the surgical resection margin in the surgical resection group. Local tumor progression (LTP) will be defined as the development of new tumor lesions within or along the margin of the ablation zone after complete ablation in the microwave ablation groups, or the appearance of new tumor lesions adjacent to the surgical resection margin during imaging follow-up in the surgical resection group. 2. Disease-free survival (DFS): DFS will be defined as the time interval from completion of treatment to tumor recurrence, metastasis, or death. It will be used to evaluate the duration of disease-free status after treatment. 3. Overall survival (OS): OS will be defined as the time interval from completion of treatment to death from any cause or the date of the last follow-up. It will be used to evaluate the impact of different treatment modalities on overall survival outcomes. Kaplan-Meier survival analysis will be performed to evaluate LTP, OS, and DFS. The log-rank test will be used to compare differences among treatment groups. Univariate and multivariate Cox proportional hazards regression models will be applied to identify independent prognostic factors associated with treatment outcomes. This study will compare OS, DFS, and local tumor progression rates among the three treatment modalities to evaluate the relationship between different treatment strategies and long-term clinical outcomes. Furthermore, recurrence patterns, recurrence locations, and subsequent treatment strategies after recurrence will be analyzed to provide evidence-based information for optimizing individualized treatment strategies for patients with subcapsular HCC.
- Conditions
- Hepatocellular Carcinoma (HCC)
- Being tested
- No-touch Microwave Ablation, Tumor-puncture Microwave Ablation, Surgical Resection
- Keywords
- Subcapsular hepatocellular carcinoma, surgical resection, local tumor control, overall survival, disease-free survival, no-touch microwave ablation, umor-puncture microwave ablation
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No-touch Microwave AblationProcedure or surgery
Under real-time ultrasound guidance, two or more microwave antennas are percutaneously inserted into the normal liver parenchyma surrounding the tumor from different directions with intersecting angles. The antenna tips are maintained approximately 5-10 mm away from the tumor margin, forming a cross-shaped configuration around the tumor without penetrating the tumor itself. The microwave ablation system is activated under continuous output mode with a power setting ranging from 30 to 80 W. The ablation duration is adjusted according to tumor size and characteristics. Multiple antennas may be activated simultaneously or sequentially to achieve adequate tumor ablation. The use of artificial hydrothorax or artificial ascites is determined according to intraoperative ultrasound visualization and the distance between the tumor and adjacent organs.
Tumor-puncture Microwave AblationProcedure or surgery
Under real-time ultrasound guidance, the microwave ablation antenna is directly inserted into the tumor. The antenna position is adjusted according to tumor size to ensure that the antenna tip is located near the center of the tumor. The microwave ablation system is activated, and the ablation zone is designed to cover the entire tumor with an additional 5-10 mm safety margin around the lesion.
Surgical ResectionProcedure or surgery
- Open Hepatectomy The abdominal cavity is entered through a conventional layered incision. Intraoperative exploration of the liver and tumor lesions is performed, and the hepatic ligaments are dissected to adequately mobilize and expose the tumor. The tumor is resected together with surrounding liver parenchyma, maintaining a safety margin of at least 5 mm according to standard surgical procedures. After meticulous hemostasis and management of the liver transection surface, the abdominal cavity is irrigated, drainage tubes are placed, and the abdominal incision is closed layer by layer.
- Laparoscopic Hepatectomy
Pneumoperitoneum is established, and laparoscopic instruments are introduced into the abdominal cavity. The liver and tumor lesions are evaluated under laparoscopic visualization, followed by liver mobilization and exposure of the lesion. After hepatic inflow occlusion using the Pringle maneuver when necessary, precise tumor resection is performed with an adequate safety
| Study group | Role | What they receive |
|---|---|---|
| No-touch Microwave Ablation Cohort | Eligible patients meeting the inclusion criteria, including those with subcapsular hepatocellular carcinoma within Milan criteria, who receive ultrasound-guided percutaneous non-contact microwave ablation as part of routine clinical practice will be included in this cohort. In this treatment modality, the ablation antenna is positioned in the normal liver parenchyma surrounding the tumor rather than directly puncturing the lesion. Tumor inactivation is achieved through microwave thermal radiation. Clinical outcomes, including local tumor control, recurrence, treatment-related complications, and survival outcomes, will be evaluated during follow-up. Receives: Procedure: No-touch Microwave Ablation | |
| Tumor-puncture Microwave Ablation Cohort | Patients with subcapsular hepatocellular carcinoma who meet the inclusion criteria and receive conventional ultrasound-guided percutaneous contact microwave ablation with direct tumor puncture as part of routine clinical practice will be included in this cohort. In this treatment modality, the microwave ablation antenna is directly inserted into the tumor under ultrasound guidance, and tumor necrosis is achieved through microwave thermal effects. During the study period, patients will be followed up to evaluate local tumor control, recurrence, treatment-related complications, and survival outcomes. Receives: Procedure: Tumor-puncture Microwave Ablation | |
| Surgical Resection Cohort | Patients with subcapsular hepatocellular carcinoma who undergo surgical resection as part of routine clinical practice will be included in this cohort. The hepatobiliary surgery team will select open or laparoscopic surgical approaches based on tumor characteristics, hepatic functional reserve, and individual patient conditions. Surgical treatment aims to achieve complete tumor removal while preserving normal liver tissue as much as possible and minimizing surgical trauma. During the study period, patients will be followed up to evaluate local tumor control, recurrence, treatment-related complications, and survival outcomes. Receives: Procedure: Surgical Resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local Tumor Control Rate
Patients will receive regular imaging follow-up after treatment to assess local tumor recurrence. Local Tumor Progression (LTP) is defined as viable lesions within the ablation zone or tumor recurrence at the surgical resection margin. For patients receiving microwave ablation, LTP refers to new lesions emerging within or at the edge of the ablation zone after complete ablation. For patients undergoing surgical resection, LTP is defined as lesions adjacent to the surgical resection margin identified on follow-up imaging.
Measure Unit: Proportion
Measured: Up to 2 years after treatment
Disease-Free Survival (DFS)
The time interval from completion of curative treatment to tumor recurrence, distant metastasis, or all-cause death.
Measure Unit: Month
Measured: Up to 2 years after treatment
Overall Survival (OS)
The time interval from completion of curative treatment to all-cause death or the last follow-up visit.
Measure Unit: Month
Measured: Up to 2 years after treatment
Secondary outcomes (3)
Time to tumor recurrence
Time interval from treatment to the first detection of tumor recurrence. Measure Unit: Month
Measured: Up to 2 years after treatment
Pattern of tumor recurrence
Classification of recurrence location, including local tumor progression, intrahepatic distant recurrence, and extrahepatic distant metastasis. The proportion of patients with each recurrence subtype will be analyzed.
Measure Unit: Proportion
Measured: Up to 2 years after treatment
Treatment modality after tumor recurrence
Therapeutic approaches adopted for patients after tumor recurrence. Measure Unit: Categorical
Measured: Up to 2 years after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2028 (estimated)
- Study completion1 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin UniversityThe 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
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dezhi Zhang, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07748481
- Sponsor's protocol ID
- 2026-394
- Status last verified
- Aug 2026
- First submitted
- 26 Jul 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared publicly due to patient privacy protection requirements and institutional data management policies. Data will only be available to the study investigators and authorized personnel involved in this research
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Therapeutic Efficacy of Non-touch Microwave Ablation, Tumor-puncture Microwave Ablation and Surgical Resection for Subcapsular Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT07748481
- Acronym / sponsor ID
- 2026-394
- Conditions
- Hepatocellular Carcinoma (HCC)
- Keywords
- Subcapsular hepatocellular carcinoma, surgical resection, local tumor control, overall survival, disease-free survival, no-touch microwave ablation, umor-puncture microwave ablation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 5 Aug 2026 (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.
Subcapsular hepatocellular carcinoma (HCC) has unique anatomical characteristics that may influence treatment selection and clinical outcomes. Surgical resection and liver transplantation are potentially curative treatments but may be limited by liver function, tumor characteristics, and perioperative risks. Microwave ablation has become an important minimally invasive treatment option for patients with HCC, particularly for lesions that are difficult to treat surgically. This prospective observational cohort study aims to compare the therapeutic efficacy, safety, and long-term outcomes of no-touch microwave ablation, tumor-puncture microwave ablation and surgical resection in patients with subcapsular HCC. Treatment outcomes, including local tumor control, treatment-related complications, recurrence, and survival outcomes, will be evaluated to provide evidence for individualized treatment strategies for patients with subcapsular HCC.
Detailed description
This single-center prospective observational cohort study will be conducted at the First Hospital of Jilin University. The study aims to evaluate and compare the therapeutic efficacy, safety, and long-term clinical outcomes of three treatment modalities, including no-touch microwave ablation, tumor-puncture microwave ablation, and surgical resection, in patients with subcapsular hepatocellular carcinoma (HCC). The study will compare local tumor control, recurrence patterns, treatment-related complications, and survival outcomes among the three groups, providing clinical evidence for individualized treatment selection and optimizing long-term management strategies for patients with subcapsular HCC. The study population will consist of patients with a confirmed diagnosis of hepatocellular carcinoma. The diagnosis of HCC will be based on the practice guidelines of the American Association for the Study of Liver Diseases (AASLD). The definition of subcapsular hepatocellular carcinoma will follow previously published criteria, in which the shortest distance between the tumor margin and the liver capsule is ≤3 mm, as confirmed by imaging examinations including ultrasound, computed tomography (CT), or magnetic resonance imaging (MRI). All enrolled patients will undergo comprehensive pre-treatment evaluations according to standard clinical practice, including routine blood tests, liver and renal function tests, coagulation assessment, serum alpha-fetoprotein (AFP) measurement, conventional ultrasound combined with contrast-enhanced ultrasound, and contrast-enhanced CT or MRI. These examinations will be used to assess tumor characteristics, hepatic functional reserve, and overall physical condition. Treatment strategies will be determined by a multidisciplinary liver cancer team based on clinical evaluation and patient-specific factors. All microwave ablation procedures will be performed by experienced interventional ultrasound physicians with more than 10 years of experience in microwave ablation therapy. During the study period, treatment responses and prognostic outcomes will be evaluated through follow-up assessments. Short-term follow-up data will include hospitalization duration and the incidence of postoperative complications, including hemorrhage, infection, needle tract seeding, thermal injury to perihepatic structures, liver failure, and ascites. Long-term therapeutic outcomes will be evaluated according to the following criteria: 1. Local tumor control rate: Patients will undergo regular imaging follow-up to evaluate local tumor recurrence. Local recurrence will be defined as the appearance of viable tumor lesions within or adjacent to the ablation zone in the microwave ablation groups, or recurrence near the surgical resection margin in the surgical resection group. Local tumor progression (LTP) will be defined as the development of new tumor lesions within or along the margin of the ablation zone after complete ablation in the microwave ablation groups, or the appearance of new tumor lesions adjacent to the surgical resection margin during imaging follow-up in the surgical resection group. 2. Disease-free survival (DFS): DFS will be defined as the time interval from completion of treatment to tumor recurrence, metastasis, or death. It will be used to evaluate the duration of disease-free status after treatment. 3. Overall survival (OS): OS will be defined as the time interval from completion of treatment to death from any cause or the date of the last follow-up. It will be used to evaluate the impact of different treatment modalities on overall survival outcomes. Kaplan-Meier survival analysis will be performed to evaluate LTP, OS, and DFS. The log-rank test will be used to compare differences among treatment groups. Univariate and multivariate Cox proportional hazards regression models will be applied to identify independent prognostic factors associated with treatment outcomes. This study will compare OS, DFS, and local tumor progression rates among the three treatment modalities to evaluate the relationship between different treatment strategies and long-term clinical outcomes. Furthermore, recurrence patterns, recurrence locations, and subsequent treatment strategies after recurrence will be analyzed to provide evidence-based information for optimizing individualized treatment strategies for patients with subcapsular HCC.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No-touch Microwave Ablation Cohort | – | Procedure: No-touch Microwave AblationEligible patients meeting the inclusion criteria, including those with subcapsular hepatocellular carcinoma within Milan criteria, who receive ultrasound-guided percutaneous non-contact microwave ablation as part of routine clinical practice will be included in this cohort. In this treatment modality, the ablation antenna is positioned in the normal liver parenchyma surrounding the tumor rather than directly puncturing the lesion. Tumor inactivation is achieved through microwave thermal radiation. Clinical outcomes, including local tumor control, recurrence, treatment-related complications, and survival outcomes, will be evaluated during follow-up. |
| Tumor-puncture Microwave Ablation Cohort | – | Procedure: Tumor-puncture Microwave AblationPatients with subcapsular hepatocellular carcinoma who meet the inclusion criteria and receive conventional ultrasound-guided percutaneous contact microwave ablation with direct tumor puncture as part of routine clinical practice will be included in this cohort. In this treatment modality, the microwave ablation antenna is directly inserted into the tumor under ultrasound guidance, and tumor necrosis is achieved through microwave thermal effects. During the study period, patients will be followed up to evaluate local tumor control, recurrence, treatment-related complications, and survival outcomes. |
| Surgical Resection Cohort | – | Procedure: Surgical ResectionPatients with subcapsular hepatocellular carcinoma who undergo surgical resection as part of routine clinical practice will be included in this cohort. The hepatobiliary surgery team will select open or laparoscopic surgical approaches based on tumor characteristics, hepatic functional reserve, and individual patient conditions. Surgical treatment aims to achieve complete tumor removal while preserving normal liver tissue as much as possible and minimizing surgical trauma. During the study period, patients will be followed up to evaluate local tumor control, recurrence, treatment-related complications, and survival outcomes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adult patients with confirmed subcapsular hepatocellular carcinoma (HCC) who receive no-touch microwave ablation, tumor-puncture microwave ablation, or surgical resection as part of routine clinical practice. The diagnosis of HCC will be established according to the practice guidelines of the American Association for the Study of Liver Diseases (AASLD). Subcapsular HCC will be defined based on imaging findings, with the shortest distance between the tumor margin and the liver capsule being ≤3 mm as confirmed by ultrasound, computed tomography (CT), or magnetic resonance imaging (MRI). Eligible patients will be prospectively enrolled and followed to evaluate treatment efficacy, safety, recurrence patterns, and long-term survival outcomes.
Key inclusion criteria (3 listed)
- Diagnosed with hepatocellular carcinoma (HCC) confirmed by pathological biopsy or clinical diagnostic criteria; Imaging examinations including ultrasound confirm that the HCC lesion is subcapsular, defined as the minimum distance between the tumor and liver capsule ≤ 3 mm; Single tumor with maximum diameter ≤ 5 cm, or up to 3 multiple tumors each with maximum diameter ≤ 3 cm; Liver function classified as Child-Pugh grade A or B; No invasion of adjacent blood vessels or vital organs; no tumor thrombus in the main portal vein or hepatic vein, and no extrahepatic metastasis.
- Exclusion Criteria:Patients with dysfunction of vital organs such as heart and lungs; Patients who received preoperative radiotherapy, chemotherapy, targeted therapy or immunotherapy, or patients complicated with other malignant tumors; Poor follow-up compliance and inability to complete the standardized follow-up procedures.
- -
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| No-touch Microwave AblationUnder real-time ultrasound guidance, two or more microwave antennas are percutaneously inserted into the normal liver parenchyma surrounding the tumor from different directions with intersecting angles. The antenna tips are maintained approximately 5-10 mm away from the tumor margin, forming a cross-shaped configuration around the tumor without penetrating the tumor itself. The microwave ablation system is activated under continuous output mode with a power setting ranging from 30 to 80 W. The ablation duration is adjusted according to tumor size and characteristics. Multiple antennas may be activated simultaneously or sequentially to achieve adequate tumor ablation. The use of artificial hydrothorax or artificial ascites is determined according to intraoperative ultrasound visualization and the distance between the tumor and adjacent organs. | Procedure or surgery | No-touch Microwave Ablation Cohort |
| Tumor-puncture Microwave AblationUnder real-time ultrasound guidance, the microwave ablation antenna is directly inserted into the tumor. The antenna position is adjusted according to tumor size to ensure that the antenna tip is located near the center of the tumor. The microwave ablation system is activated, and the ablation zone is designed to cover the entire tumor with an additional 5-10 mm safety margin around the lesion. | Procedure or surgery | Tumor-puncture Microwave Ablation Cohort |
| Surgical Resection1. Open Hepatectomy The abdominal cavity is entered through a conventional layered incision. Intraoperative exploration of the liver and tumor lesions is performed, and the hepatic ligaments are dissected to adequately mobilize and expose the tumor. The tumor is resected together with surrounding liver parenchyma, maintaining a safety margin of at least 5 mm according to standard surgical procedures. After meticulous hemostasis and management of the liver transection surface, the abdominal cavity is irrigated, drainage tubes are placed, and the abdominal incision is closed layer by layer. 2. Laparoscopic Hepatectomy Pneumoperitoneum is established, and laparoscopic instruments are introduced into the abdominal cavity. The liver and tumor lesions are evaluated under laparoscopic visualization, followed by liver mobilization and exposure of the lesion. After hepatic inflow occlusion using the Pringle maneuver when necessary, precise tumor resection is performed with an adequate safety | Procedure or surgery | Surgical Resection Cohort |
Primary outcome
Local Tumor Control Rate
Time frame: Up to 2 years after treatment
Patients will receive regular imaging follow-up after treatment to assess local tumor recurrence. Local Tumor Progression (LTP) is defined as viable lesions within the ablation zone or tumor recurrence at the surgical resection margin. For patients receiving microwave ablation, LTP refers to new lesions emerging within or at the edge of the ablation zone after complete ablation. For patients undergoing surgical resection, LTP is defined as lesions adjacent to the surgical resection margin identified on follow-up imaging. Measure Unit: Proportion
Disease-Free Survival (DFS)
Time frame: Up to 2 years after treatment
The time interval from completion of curative treatment to tumor recurrence, distant metastasis, or all-cause death. Measure Unit: Month
Overall Survival (OS)
Time frame: Up to 2 years after treatment
The time interval from completion of curative treatment to all-cause death or the last follow-up visit. Measure Unit: Month
3 secondary outcomes
Time to tumor recurrence
Time frame: Up to 2 years after treatment
Pattern of tumor recurrence
Time frame: Up to 2 years after treatment
Treatment modality after tumor recurrence
Time frame: Up to 2 years after treatment
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 5 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared publicly due to patient privacy protection requirements and institutional data management policies. Data will only be available to the study investigators and authorized personnel involved in this research
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma (HCC), run by The First Hospital of Jilin University.
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 3 inclusion and 0 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: opening soon, as of the sponsor's last update on 5 Aug 2026. 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?
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 Dezhi Zhang Associate Chief Physician, MD (Tel: +86 0431-88782190, dezhi@jlu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local Tumor Control Rate (time frame: Up to 2 years after treatment). The study lists 3 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 5 Aug 2026.