Skip to main content
OpenTrials
Completed

NCT Number: NCT04710459

Endobronchial Cryotherapy in Management of MEBO in Patients With Inoperable NSCLC

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Non Small Cell Lung Cancer Bronchial Neoplasms Bronchogenic Cancer Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Non-Small Cell Carcinoma of Lung, TNM Stage 4 Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

47 year–71 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

cryotherapy

Procedure

Group 1 included 30 patients, they were subjected to chemoradiotherapy plus endobronchial cryotherapy. Group 2 included include 30 patients, they were subjected to chemoradiotherapy.

Primary outcomes

  1. 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

  2. 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 %).

  3. 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

  4. 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

  1. Arterial blood gases evaluation

    Time frame: 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).

  2. Six minute walk distance test

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Mohamed Abdel Bary Ahmed Ibrahim

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jan 14, 2021
Registry last updated
Mar 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.