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

NCT07748481 | Not Yet Recruiting

• 1 other identifier: 2026-394
• Study Type: observational
• Target: 180
• Locations: 0 countries
• Sites: N/A

Brief 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.

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

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  Up to 2 years after treatment

Secondary Outcomes (3)

• Time to tumor recurrence

  Up to 2 years after treatment

• Pattern of tumor recurrence

  Up to 2 years after treatment

• Treatment modality after tumor recurrence

  Up to 2 years after treatment

Study Arms (3)

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.

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.

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.

Procedure: Surgical Resection

Interventions

No-touch Microwave Ablation PROCEDURE

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.

No-touch Microwave Ablation Cohort

Tumor-puncture Microwave Ablation PROCEDURE

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.

Tumor-puncture Microwave Ablation Cohort

Surgical Resection PROCEDURE

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

Surgical Resection Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

Sponsors & Collaborators

• The First Hospital of Jilin University: lead

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Central Study Contacts

Dezhi Zhang Associate Chief Physician, MD

CONTACT

Tel: +86 0431-88782190; dezhi@jlu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investiogator,PI

Study Record Dates

• First Submitted: July 26, 2026
• First Posted: August 5, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): May 1, 2029
• Last Updated: August 5, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share