Airway ObstructionNCT02299830
Study of Interventional Pulmonologic Treatment of Malignant Central Airway Stricture
A study testing cryotherapy, argon plasma coagulation and stent placement in people with Airway Obstruction, run by Tang-Du Hospital at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of four interventional pulmonology techniques for the treatment of malignant central airway stricture. The four techniques are： cryotherapy argon plasma coagulation stent snare Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Airway Obstruction
- What is being tested?
- cryotherapy, argon plasma coagulation and stent placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Dec 2014to Dec 2017
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- malignant neoplasm caused central airway stenosis
- the degree of stenosis is above 50%
- estimated survival duration is longer than 3 months
- received no treatment one month before
- can understand the statement informed consent
- agree to enroll in the study
Who cannot join
- older than 70 years or younger than 18 years
- not malignant neoplasm caused central airway stenosis
- not central airway stenosis
- existence of lumina collapse or twisting
- severe arrhythmia, myocardial ischemia or hypertensive crisis
- coagulation disorders
Show all 9Show fewer
- existence of severe organ disfunction
- allergic to anesthesia drugs
- refuse to participate the study
Trial locations and contacts
1 site in 1 country.
China1 site
Tangdu Hospital
Xi'an, Shaanxi, 710038
Deguang Mu, Ph.D, 86-29-84777825, deguang@fmmu.edu.cn
Deguang Mu, Ph.D
About this study
Official title: Prospective, Open, Multicenter Study of Interventional Pulmonologic Treatment of Malignant Central Airway Stricture
The purpose of this study is to evaluate the efficacy and safety of four interventional pulmonology techniques for the treatment of malignant central airway stricture.
The four techniques are：
- cryotherapy
- argon plasma coagulation
- stent
- snare
- Conditions
- Airway Obstruction
- Being tested
- cryotherapy, argon plasma coagulation, stent placement, deletion tumor tissue by snare
- Keywords
- neoplasm, central airway, obstruction
- Medical subject headings
- Airway Obstruction, Neoplasms, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cryotherapyProcedure or surgery
use cryotherapy to delete soft neoplasm tissue in the airway
argon plasma coagulationProcedure or surgery
use argon plasma coagulation to delete hard neoplasm tissue in the airway
stent placementProcedure or surgery
use stent placement to open the airway compressed by out neoplasm
deletion tumor tissue by snareProcedure or surgery
use snare to delete polypoid neoplasm tissue in the airway
| Study group | Role | What they receive |
|---|---|---|
| cryotherapy | Experimental | give the cases whose central airway stricture were caused by soft neoplasm tissues cryotherapy Receives: Procedure: cryotherapy |
| argon plasma coagulation | Experimental | give the cases whose central airway stricture were caused by hard neoplasm tissues argon plasma coagulation Receives: Procedure: argon plasma coagulation |
| stent | Experimental | give the cases whose central airway stricture were caused by neoplasm compression stent placement Receives: Procedure: stent placement |
| snare | Experimental | give the cases whose central airway stricture were caused by polypoid neoplasm tissues snare Receives: Procedure: deletion tumor tissue by snare |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of the cases that got Ⅰand Ⅱlevel remission
Measured: the next day after the treatment
Secondary outcomes (2)
the values of dyspnea index
Measured: the next day after the treatment
Karnofsky Physical scales
Measured: the next day after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study startDec 2014
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway ObstructionStudies of the same condition, open and under way.
- More trials run by Tang-Du HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Changhai Hospital, The First Affiliated Hospital of Guangzhou Medical University, Xinqiao Hospital of Chongqing, China Meitan General Hospital, MICRO-TECH (Nanjing) Co., Ltd
- Responsible party
- Sponsor
- Investigators
- Faguang Jin, Ph.D, Principal investigator, Tang-Du Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02299830
- Sponsor's protocol ID
- CAO-NO.201402024-malignant1
- Other IDs
- NO.201402024
- Status last verified
- Nov 2014
- First submitted
- 26 Oct 2014
- Last updated
- 24 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Open, Multicenter Study of Interventional Pulmonologic Treatment of Malignant Central Airway Stricture
- ClinicalTrials.gov ID
- NCT02299830
- Acronym / sponsor ID
- CAO-NO.201402024-malignant1
- Conditions
- Airway Obstruction
- Keywords
- neoplasm, central airway, obstruction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Collaborators
- Changhai Hospital, The First Affiliated Hospital of Guangzhou Medical University, Xinqiao Hospital of Chongqing, China Meitan General Hospital, MICRO-TECH (Nanjing) Co., Ltd
- Study start
- Dec 2014
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 24 Nov 2014 (estimated)
- 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 purpose of this study is to evaluate the efficacy and safety of four interventional pulmonology techniques for the treatment of malignant central airway stricture.
The four techniques are：
- cryotherapy
- argon plasma coagulation
- stent
- snare
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| cryotherapy | Experimental | Procedure: cryotherapygive the cases whose central airway stricture were caused by soft neoplasm tissues cryotherapy |
| argon plasma coagulation | Experimental | Procedure: argon plasma coagulationgive the cases whose central airway stricture were caused by hard neoplasm tissues argon plasma coagulation |
| stent | Experimental | Procedure: stent placementgive the cases whose central airway stricture were caused by neoplasm compression stent placement |
| snare | Experimental | Procedure: deletion tumor tissue by snaregive the cases whose central airway stricture were caused by polypoid neoplasm tissues snare |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- malignant neoplasm caused central airway stenosis
- the degree of stenosis is above 50%
- estimated survival duration is longer than 3 months
- received no treatment one month before
- can understand the statement informed consent
Key exclusion criteria (9 listed)
- older than 70 years or younger than 18 years
- not malignant neoplasm caused central airway stenosis
- not central airway stenosis
- existence of lumina collapse or twisting
- severe arrhythmia, myocardial ischemia or hypertensive crisis
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 |
|---|---|---|
| cryotherapyuse cryotherapy to delete soft neoplasm tissue in the airway | Procedure or surgery | cryotherapy |
| argon plasma coagulationuse argon plasma coagulation to delete hard neoplasm tissue in the airway | Procedure or surgery | argon plasma coagulation |
| stent placementuse stent placement to open the airway compressed by out neoplasm | Procedure or surgery | stent |
| deletion tumor tissue by snareuse snare to delete polypoid neoplasm tissue in the airway | Procedure or surgery | snare |
Primary outcome
percentage of the cases that got Ⅰand Ⅱlevel remission
Time frame: the next day after the treatment
2 secondary outcomes
the values of dyspnea index
Time frame: the next day after the treatment
Karnofsky Physical scales
Time frame: the next day after the treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2014.
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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.
Faguang Jin, Ph.D principal investigator
Tang-Du Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cryotherapy, argon plasma coagulation and stent placement in people with Airway Obstruction, run by Tang-Du Hospital at 1 site in China.
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 6 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 24 Nov 2014. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Deguang Mu, Ph.D (86-29-777825, deguang@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of the cases that got Ⅰand Ⅱlevel remission (time frame: the next day after the treatment). 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 24 Nov 2014.