Endobronchial MassEVERMORENCT03903315
Central Malignant Airway Obstructions: Medical Treatment Alone Versus Endoscopic and Medical Treatmen
An observational study of Endobronchial Mass and Lung Cancer, run by University of Modena and Reggio Emilia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Endobronchial Mass, Lung Cancer
- What is being tested?
- Comparison between patients with Patients with central malignant airway obstructions undergoing medical treatment alone versus medical and endoscopic treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 Aug 2019to 1 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
Study population: Patients with malignant central airways obstruction treated with medical therapy alone or endoscopic treatment and medical therapy
Who may be able to join
- 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)
Who cannot join
- metastatic disease
- small cell lung cancer
- pregnancy
- low performance status at the time of diagnosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Central Malignant Airway Obstructions: Medical Treatment Alone Versus Endoscopic and Medical Treatment. A Multicentric Retrospective Study
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.
Read more
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.
- Conditions
- Endobronchial Mass, Lung Cancer
- Being tested
- Comparison between patients with Patients with central malignant airway obstructions undergoing medical treatment alone versus medical and endoscopic treatment
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparison between patients with Patients with central malignant airway obstructions undergoing medical treatment alone versus medical and endoscopic treatmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| medical treatment alone | Patients with central malignant airway obstructions undergoing medical treatment alone Receives: Other: Comparison between patients with Patients with central malignant airway obstructions undergoing medical treatment alone versus medical and endoscopic treatment | |
| endoscopic + medical treatment | Patients with central malignant airway obstructions undergoing medical and endoscopic treatment Receives: Other: Comparison between patients with Patients with central malignant airway obstructions undergoing medical treatment alone versus medical and endoscopic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
1 year Survival
Assessment of survival through medical records and reports consultation
Measured: Ten years
Secondary outcomes (5)
Infections
Assessment of the onset of infections through medical records and reports consultation
Measured: Ten years
Respiratory failure
Assessment of the onset of respiratory failure through medical records and reports consultation
Measured: Ten years
Hospital admission
Assessment of the occurrence of hospital admission through medical records and reports consultation
Measured: Ten years
Need for palliative care
Assessment of the need to start palliative support through medical records and reports consultation
Measured: Ten years
Atelectasis
Assessment of the occurrence of atelectasis through medical records and reports consultation
Measured: Ten years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2019
- Study start1 Aug 2019
- Primary completion1 Jan 2020
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endobronchial MassStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Modena and Reggio Emilia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandro Marchioni, University of Modena and Reggio Emilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03903315
- Sponsor's protocol ID
- UModenaReggio 7
- Acronym
- EVERMORE
- Status last verified
- Mar 2022
- First submitted
- 2 Apr 2019
- Last updated
- 23 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central Malignant Airway Obstructions: Medical Treatment Alone Versus Endoscopic and Medical Treatment. A Multicentric Retrospective Study
- ClinicalTrials.gov ID
- NCT03903315
- Acronym / sponsor ID
- EVERMORE / UModenaReggio 7
- Conditions
- Endobronchial Mass, Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Modena and Reggio EmiliaUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 4 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| medical treatment alone | – | Other: Comparison between patients with Patients with central malignant airway obstructions undergoing medical treatment alone versus medical and endoscopic treatmentPatients with central malignant airway obstructions undergoing medical treatment alone |
| endoscopic + medical treatment | – | Other: Comparison between patients with Patients with central malignant airway obstructions undergoing medical treatment alone versus medical and endoscopic treatmentPatients with central malignant airway obstructions undergoing medical and endoscopic treatment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with malignant central airways obstruction treated with medical therapy alone or endoscopic treatment and medical therapy
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (4 listed)
- metastatic disease
- small cell lung cancer
- pregnancy
- low performance status at the time of diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comparison between patients with Patients with central malignant airway obstructions undergoing medical treatment alone versus medical and endoscopic treatmentComparison between patients with Patients with central malignant airway obstructions undergoing medical treatment alone versus medical and endoscopic treatment with reference to mortality and complications. | Other | endoscopic + medical treatment, medical treatment alone |
Primary outcome
1 year Survival
Time frame: Ten years
Assessment of survival through medical records and reports consultation
5 secondary outcomes
Infections
Time frame: Ten years
Respiratory failure
Time frame: Ten years
Hospital admission
Time frame: Ten years
Need for palliative care
Time frame: Ten years
Atelectasis
Time frame: Ten years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endobronchial Mass and Lung Cancer, run by University of Modena and Reggio Emilia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1 year Survival (time frame: Ten years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2022.