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Central Malignant Airway Obstructions: Medical Treatment Alone Versus Endoscopic and Medical Treatmen (EVERMORE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03903315
Recruitment Status : Active, not recruiting
First Posted : April 4, 2019
Last Update Posted : May 13, 2020
Sponsor:
Information provided by (Responsible Party):
Alessandro Marchioni, University of Modena and Reggio Emilia

Brief Summary:

The obstruction of the central airways (CAO) may be caused by a large variety of malignant and non malignant processes, and it may present with a variety of symptoms ranging from mild shortness of breath to life-threatening respiratory failure.

The epidemiologic impact of lung cancer leads to an increasing number of patients developing complications of proximal endobronchial disease. An estimated 20-30% of patients with lung cancer will develop complications associated with airway obstruction, e.g. dyspnea, pneumonia and atelectasis, and up to 40% of lung cancer deaths may be attributed to locoregional disease.

Although lung cancer patients with CAO are not candidates for surgical resection, more than 80% of these patients can receive palliative treatment using interventional bronchoscopy; in addiction, almost the 85% of these procedures reach luminal clearance and endoscopic success in terms of symptomatic relief, of pulmonary function and quality of life.

There are no definitive data about factors such as type of disease or site of the lesion which may affect the use of a single or a combined endoscopic modality or stenting in the treatment of airway obstructions. A Dalar's retrospective study showed that airway stenting is a useful treatment modality besides the other interventional bronchoscopic procedures: it not only provides rapid relief of symptoms and an improved quality of life, but also gives additional time for adjuvant chemo-radiotherapy that might provide prolonged survival.

Since Dumon introduced the first dedicated endoluminal airway stent, there was a clear immediate relief of respiratory symptoms and significant quality survival in most patients (9). In a Miyazawa's study all patients with malignant central airway obstruction had significant improvements in dyspnea and also in spirometry after stenting, and the author suggested that the correct positioning of the stent at the choke point leads to maximal symptomatic benefit in these patients. The choice of different airway stents can be made based on the nature (intrinsic, extrinsic or combined) and site of the lesion: for example the Dumon stent can be preferred in lesions of trachea and right main bronchus, the Ultraflex stent on the left and stenosis beyond the main bronchi. The underlying disease, the site of lesion and treatment modality are known as independent predictors of survival. Complications related to the placement of stents include re-obstructions of the lumen by tumor, granuloma formation at the stent side, mucous plugging and migration of the stent; with the use of laser, both perforation of airway wall and fire.

Regarding laser resection for malignant airway obstruction, it is associated with improved survival rates (60% of patients alive at 7 months in one study). As these studies were not randomized trials, it is impossible to conclude that the laser therapy was responsible for the improved survival, but it is likely that laser therapy provided a rapid and safe means of relieving central airway obstruction, which is associated with a high mortality rate.

The strategy and modality of treatment for malignant central airway obstructions depends not only on the endoscopic characteristics and location of the lesions, but also on the patient's comorbidities, pulmonary function, previous treatment and life expectancy. The primary purpose of treatment with interventional bronchoscopy alone remains to improve symptom control and quality of life, not to improve the prognosis. However, the advent of molecular-targeted therapy may change the impact of interventional bronchoscopy, especially in lung cancer patients with EGFR mutations: in a Tomoyuki case report there is the first description of the use of endoscopic treatment plus molecular-targeted therapy as combination treatment, with benefits in terms of patient's general conditions and quality of life. Moreover, some researchers have reported cases of malignant lymphoma patients with central airway obstruction who were successfully treated using interventional bronchoscopy followed by systemic chemotherapy.

The aim of this study is to evaluate the differences between patients with central malignant airway obstruction treated only with medical therapy versus patients submitted to endoscopic plus medical therapy in terms of prognosis, quality of life and access to health services.


Condition or disease Intervention/treatment
Endobronchial Mass Lung Cancer Other: Comparison between patients with Patients with central malignant airway obstructions undergoing medical treatment alone versus medical and endoscopic treatment

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Central Malignant Airway Obstructions: Medical Treatment Alone Versus Endoscopic and Medical Treatment. A Multicentric Retrospective Study
Actual Study Start Date : August 1, 2019
Actual Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Choking Endoscopy

Group/Cohort Intervention/treatment
medical treatment alone
Patients with central malignant airway obstructions undergoing medical treatment alone
Other: Comparison between patients with Patients with central malignant airway obstructions undergoing medical treatment alone versus medical and endoscopic treatment
Comparison between patients with Patients with central malignant airway obstructions undergoing medical treatment alone versus medical and endoscopic treatment with reference to mortality and complications.

endoscopic + medical treatment
Patients with central malignant airway obstructions undergoing medical and endoscopic treatment
Other: Comparison between patients with Patients with central malignant airway obstructions undergoing medical treatment alone versus medical and endoscopic treatment
Comparison between patients with Patients with central malignant airway obstructions undergoing medical treatment alone versus medical and endoscopic treatment with reference to mortality and complications.




Primary Outcome Measures :
  1. 1 year Survival [ Time Frame: Ten years ]
    Assessment of survival through medical records and reports consultation


Secondary Outcome Measures :
  1. Infections [ Time Frame: Ten years ]
    Assessment of the onset of infections through medical records and reports consultation

  2. Respiratory failure [ Time Frame: Ten years ]
    Assessment of the onset of respiratory failure through medical records and reports consultation

  3. Hospital admission [ Time Frame: Ten years ]
    Assessment of the occurrence of hospital admission through medical records and reports consultation

  4. Need for palliative care [ Time Frame: Ten years ]
    Assessment of the need to start palliative support through medical records and reports consultation

  5. Atelectasis [ Time Frame: Ten years ]
    Assessment of the occurrence of atelectasis through medical records and reports consultation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients with malignant central airways obstruction treated with medical therapy alone or endoscopic treatment and medical therapy
Criteria

Inclusion Criteria:

  • patients with malignant central airways obstruction admitted to the Bronchoscopy Unit of the University Hospital of Modena (Italy) and to the Bronchoscopy Unit of the Arcispedale Santa Maria Nuova of Reggio Emilia (Italy)

Exclusion Criteria:

  • metastatic disease
  • small cell lung cancer
  • pregnancy
  • low performance status at the time of diagnosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03903315


Locations
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Italy
Azienda Ospedaliero Universitaria Policlinico di Modena
Modena, Italy
Sponsors and Collaborators
University of Modena and Reggio Emilia
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Responsible Party: Alessandro Marchioni, Principal Investigator, University of Modena and Reggio Emilia
ClinicalTrials.gov Identifier: NCT03903315    
Other Study ID Numbers: UModenaReggio 7
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: May 13, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Airway Obstruction
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases