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NOT YET RECRUITING
NCT07748481

Comparison of the Therapeutic Efficacy of Non-touch Microwave Ablation, Tumor-puncture Microwave Ablation and Surgical Resection for Subcapsular Hepatocellular Carcinoma

Sponsor: The First Hospital of Jilin University

View on ClinicalTrials.gov

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. 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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

180

Start Date

2026-10-01

Completion Date

2029-05-01

Last Updated

2026-08-05

Healthy Volunteers

No

Interventions

PROCEDURE

No-touch Microwave Ablation

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.

PROCEDURE

Tumor-puncture Microwave Ablation

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.

PROCEDURE

Surgical Resection

1. 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