The Value of Endobronchial Cryotherapy in the Management of Malignant Endobronchial Obstruction in Patients With Inoperable NSCLC: A Prospective Analysis of Clinical and Survival Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 主要终点
- Respiratory function test evaluation
研究概览
简要总结
Background: In end-stage patients when all management options have been used, will often develop compromise of their airways as the cancer continues to progress. Endobronchial therapy options may help to relieve some of their symptoms, allowing improvement in their shortness of breath as they go home in combination with other palliative therapies.
Objective: to compare the safety ; efficacy; and clinical outcome of endobronchial cryotherapy combined with chemotherapy and/ or radiotherapy versus chemo-radiotherapy alone on patients with Non small cell lung cancer.
Patients and method(s): A prospective randomized clinical trial was carried out on 60 patients with different ages of both sexes, diagnosed as bronchogenic carcinoma non-small cell lung cancer type (NSCLC) . The patients attended the hospital in the chest department, Qena Faculty of Medicine, South Valley University. Assessment of the patients was done and randomly assigned into two groups. Group1 ,Include 30 patients subjected to chemotherapy , radiotherapy and endobronchial cryotherapy.Group 2 , Include include 30 patients subjected to chemotherapy and radiotherapy alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 47 Years 至 71 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All cases with pathologically proved and inoperable NSCLC cases based on tumor position; in the main and subsegmental bronchi.
排除标准
- •Cases with severe respiratory distress, uncorrectable impaired bleeding profile and prechemotherapy.
结局指标
主要结局
Respiratory function test evaluation
时间窗: Change from Baseline Spirometry done before management, was compared with that was done at 4 weeks after management.
Spirometry was done (FEV1 in %, FVC in %, FEV1/FVC in %).
Assessment of the overall survival
时间窗: The overall survival was measured by the percentage of patients who still alive for 12 months after they were started the management.
Assessment of the overall survival was done by Kaplan-Meier method
Evaluation of the clinical changes of the cases after procedure.
时间窗: the symptoms were evaluated before therapy as a baseline; and evaluated 4 weeks after procedure.
Evaluation of the rate of symptoms relief after therapy
Assessment of the performance status
时间窗: The mean Karnofsky performance score was done before treatment as a baseline; and 4 weeks after treatment.
It was performed using the mean Karnofsky performance score
次要结局
- Six minute walk distance test(Six minute walk test was done before treatment as a baseline; and 4 weeks after treatment.)
- Arterial blood gases evaluation(Arterial blood gases was done before treatment as a baseline; and 4 weeks after treatment.)
研究者
Mohamed Abdel Bary Ahmed Ibrahim
Associate professor
South Valley University