Endobronchial Cryotherapy in Management of MEBO in Patients With Inoperable NSCLC

Not Applicable

Completed

• Conditions: Non Small Cell Lung Cancer; Non-Small Cell Carcinoma of Lung, TNM Stage 4; Bronchogenic Cancer
• Interventions: Procedure: cryotherapy

• Registration Number: NCT04710459
• Lead Sponsor: Mohamed Abdel Bary Ahmed Ibrahim

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12
• Primary Completion: 2019-04
• Study Completion: 2019-05
• Study First Submitted: 2020-04-16
• Study First Submitted QC: 2021-01-12
• Study First Posted: 2021-01-14
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-04
• Last Update Posted: 2021-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	cryotherapy	it included 30 patients, they were subjected to chemoradiotherapy plus endobronchial cryotherapy.

Primary Outcome Measures

Name	Time	Method
Respiratory function test evaluation	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	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.	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	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 Outcome Measures

Name	Time	Method
Six minute walk distance test	Six minute walk test was done before treatment as a baseline; and 4 weeks after treatment.	Six minute walk distance test was measured in minutes
Arterial blood gases evaluation	Arterial blood gases was done before treatment as a baseline; and 4 weeks after treatment.	It included; Mean So2 (mm Hg), Mean PaO2 (mmHg), Mean PaCo2 (mm Hg).