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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Non Small Cell Lung Cancer
- Sponsor
- Mohamed Abdel Bary Ahmed Ibrahim
- Enrollment
- 60
- Primary Endpoint
- Respiratory function test evaluation
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Investigators
Mohamed Abdel Bary Ahmed Ibrahim
Associate professor
South Valley University
Eligibility Criteria
Inclusion Criteria
- •All cases with pathologically proved and inoperable NSCLC cases based on tumor position; in the main and subsegmental bronchi.
Exclusion Criteria
- •Cases with severe respiratory distress, uncorrectable impaired bleeding profile and prechemotherapy.
Outcomes
Primary Outcomes
Respiratory function test evaluation
Time Frame: 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
Time Frame: 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.
Time Frame: 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
Time Frame: 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
Secondary Outcomes
- 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.)