Endobronchial Cryotherapy in Management of MEBO in Patients With Inoperable NSCLC

NCT ID: NCT04710459

Last Updated: 2021-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2019-05-31

Brief Summary

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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

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Conditions

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Non Small Cell Lung Cancer Non-Small Cell Carcinoma of Lung, TNM Stage 4 Bronchogenic Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1

it included 30 patients, they were subjected to chemoradiotherapy plus endobronchial cryotherapy.

Group Type ACTIVE_COMPARATOR

cryotherapy

Intervention Type 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.

Group 2

it included include 30 patients, they were subjected to chemoradiotherapy.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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cryotherapy

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

47 Years

Maximum Eligible Age

71 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mohamed Abdel Bary Ahmed Ibrahim

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Abdel Bary Ahmed Ibrahim

Associate professor

Responsibility Role SPONSOR_INVESTIGATOR

Other Identifiers

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SVU-MED-84-10-12-2016

Identifier Type: -

Identifier Source: org_study_id

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