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临床试验/NCT04081181
NCT04081181Unknown不适用

CT_ Guided Percutaneous Microwave Ablation in Treatment of Pulmonary Malignancies

Assiut University0 个研究点目标入组 19 人开始时间: 2020年7月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
19
主要终点
Percentage of patients achieving adequacy of ablation

研究概览

简要总结

Lung cancer remains to be an important global issue as it is the leading cause of cancer_ related mortality for both men and women worldwide .Since more than two thirds of cases are diagnosed at an advanced stage,the survival rate of lung cancer is one of the lowest among all cancers.

详细描述

Currently , Surgery is one of the curative treatment option for primary lung cancer but most patients are either diagnosed at an advanced stage or are unfit for surgery due to medical co_morbidities or poor underlying lung reserve , less than a third of all lung cancer patients can undergo surgical resection .

Lung metastasectomy is considered a therapeutic option increasing the survival rate for patients of pulmonary metastases but only 25%30% of patients benefits from lung metastasectomy due to multiplicity of pulmonary nodules or medical co morbidities .

In spite of a significant improvement of lung cancer chemotherapy and radiotherapy in recent years , the overall clinical outcome is less than satisfactory compared with that brought by surgical resection .Thus , it is urgent to provide a method which is more effective than chemotherapy and radiotherapy and nearly effective as the surgical treatment for the patients who are not eligible for surgery.

Local thermal ablation therapy of the tumor is the focus of recent research in the past decades .This method is to deliver specific energy into the tumor tissue under the guidance of image technology , which make the local tissue quickly reach 60°C where an irreversible coagulative necrosis happens leading to necrosis of tumor cells .

CT_guided Microwave ablation is a minimally invasive technique that may be an alternative treatment option for management of lung cancer in patients who are not candidate for surgery .This method not only kill the insitu lung cancer cells , but also protect lung cancer tissue .It can produce large volumes of cellular necrosis with reduced procedure time , can use multiple antennae and can be used in lesions with cystic component and/or in proximity to vascular structures.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • patient has good compliance and sign the informed consent.
  • patient with lung cancer who lost the opportunity of surgical resection.
  • patient has one or more metastatic lung nodules (not more than 5)

排除标准

  • patient is pregnant or breast feeding .
  • patient with uncorrectable coagulopathy.
  • There are large blood vessels or important structures adjacent to lung lesion.
  • patient with more than five nodules

结局指标

主要结局

Percentage of patients achieving adequacy of ablation

时间窗: 24 hours post ablation

Defined as perilesional circumferential solid area of ground glass opacification of \>4mm

Percentage of patients achieving technical efficacy

时间窗: 1 month after ablation

Defined as lack of enhancement within the ablated zone

Local progression free survival

时间窗: From the date of ablation up to six months

The interval between microwave ablation and evidence of local recurrence. Local recurrence defined as enlargement of the zone , the development of contrast enhancement in the part of the zone or change in the size of the ablated zone as a result if enlargement of one area.

次要结局

  • Adverse events(From the date of ablation up to six months follow up)

研究者

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

Reham M Farghally

Principal Investigator

Assiut University

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