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临床试验/NCT07213050
NCT07213050尚未招募不适用

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

Assiut University0 个研究点目标入组 30 人开始时间: 2025年11月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
主要终点
Technical Success

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Technical Success

时间窗: baseline

complete coverage of the target lesion by the ablation zone with an adequate margin on the immediate post-procedure CT scan

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

MOHAMED ALI IBRAHIM ABOLOYOUN SAYED

residant doctor at Assiut university hospital

Assiut University

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