About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial 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.
Trial design
Cohort
Prospective
Treatments tested in this trial
No-touch Microwave Ablation
Procedure/SurgeryUnder 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 Ablation
Procedure/SurgeryUnder 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 Resection
Procedure/Surgery1. 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
Treatment groups
Trial outcomes
Primary outcomes
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
Disease-Free Survival (DFS)
The time interval from completion of curative treatment to tumor recurrence, distant metastasis, or all-cause death. Measure Unit: Month
Overall Survival (OS)
The time interval from completion of curative treatment to all-cause death or the last follow-up visit. Measure Unit: Month
Secondary outcomes
Time to tumor recurrence
Time interval from treatment to the first detection of tumor recurrence. Measure Unit: Month
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
Treatment modality after tumor recurrence
Therapeutic approaches adopted for patients after tumor recurrence. Measure Unit: Categorical
Locations
Sponsors and contacts
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