Percutaneous Thermal Ablation (Radiofrequency and Microwave) in the Treatment of Anterior Abdominal Wall Masses: An Evaluation of Efficacy and Safety.

NCT ID: NCT07213050

Last Updated: 2025-10-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-01
• Study Completion Date: 2026-12-01

Brief Summary

The anterior abdominal wall is a common site for metastatic deposits (e.g., from colorectal, ovarian, or hepatocellular carcinoma), desmoid tumors (aggressive fibromatosis), and endometriomas. Surgical resection has been the traditional standard of care. However, surgery in this region can be complex due to the proximity of vital structures, the need for large tissue resection, and high recurrence rates. Furthermore, patients often present with significant comorbidities or have recurrent disease after previous surgeries, making them poor surgical candidates While established in organs like the liver and lungs, their application specifically for abdominal wall lesions is a growing and evidence-supported field that warrants further systematic study to standardize protocols and confirm long-term outcomes.

Percutaneous thermal ablation, including microwave ablation (MWA) and radiofrequency ablation (RFA), is an increasingly used minimally invasive treatment for anterior abdominal wall lesions such as metastatic tumors and benign lesions like abdominal wall endometriosis. These techniques deliver thermal energy through percutaneous probes to induce coagulative necrosis, offering an effective alternative to surgery with lower morbidity and shorter recovery times.

RFA uses high-frequency electrical currents to generate heat and ablate tumors. It is well established for treating abdominal wall recurrences, particularly from colorectal cancer, with effective local control and symptom relief.

Ultrasound-guided MWA has demonstrated excellent safety and efficacy for abdominal wall lesions. Studies report significant lesion volume reduction, pain relief, and low complication rates in patients with abdominal wall endometriosis and metastases. The ability to visualize the ablation zone in real-time with ultrasound enhances precision and protects adjacent structures.

Conditions

Anterior Abdominal Wall Masses

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

study group

Patients with biopsy-proven metastases to the anterior abdominal wall (e.g.,from colorectal, breast, ovarian cancer)

Group Type: ACTIVE_COMPARATOR

Radiofrequency

Intervention Type: PROCEDURE

achieve a target temperature of 90-110°C for 4-12 minutes, ensuring an ablative margin of at least 0.5-1.0 cm around the tumor.

Microwave

Intervention Type: PROCEDURE

Antennas will be placed under imaging guidance, and ablation will be performed for 5-10 minutes per antenna activation to achieve the desired margin.

Interventions

Radiofrequency

achieve a target temperature of 90-110°C for 4-12 minutes, ensuring an ablative margin of at least 0.5-1.0 cm around the tumor.

Intervention Type: PROCEDURE

Microwave

Antennas will be placed under imaging guidance, and ablation will be performed for 5-10 minutes per antenna activation to achieve the desired margin.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 1. Patients with biopsy-proven metastases to the anterior abdominal wall (e.g., from colorectal, breast, ovarian cancer). 2. Patients with biopsy-proven desmoid tumors (aggressive fibromatosis). 3. Patients with symptomatic abdominal wall endometriomas. 4. Lesion size ≤ 5 cm in greatest diameter. 5. Patients deemed unfit for surgery due to comorbidities, or who refuse surgical intervention. 6. Platelet count > 50,000/µL and INR < 1.5.

Exclusion Criteria

• 1. Uncorrectable coagulopathy. 2. Lesion size > 5 cm. 3. Unlimited diffuse peritoneal carcinomatosis. 4. Skin or bowel wall involvement with no safe percutaneous pathway for ablation (as determined on pre-procedural CT) 5. Life expectancy < 3 months.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

MOHAMED ALI IBRAHIM ABOLOYOUN SAYED

residant doctor at Assiut university hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Percutaneous Thermal Ablation

Identifier Type: -

Identifier Source: org_study_id