Endobronchial Cryotherapy in Management of MEBO in Patients With Inoperable NSCLC

Mohamed Abdel Bary Ahmed Ibrahim

Status: Completed

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

Treatments: Procedure: cryotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04710459

SVU-MED-84-10-12-2016

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 47 to 71 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 2 patient groups

Group 1

Active Comparator group

Description:

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

Treatment:

Procedure: cryotherapy

Group 2

No Intervention group

Description:

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