Chronic Obstructive Pulmonary DiseaseNCT01006200
Factors to Obstructive Granulation Tissue Formation After Ultraflex Stenting in Benign Tracheal Narrowing
An observational study of Chronic Obstructive Pulmonary Disease, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
This study is aimed to determine factors leading to obstructive granulation tissue formation after placement of Self-Expandable Metallic Stent (SEMS) in patients with benign tracheal diseases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- How many people
- 67 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2001to Sep 2007
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with benign tracheal stenosis who underwent endoscopic tracheal stent placements at the Chang Gung Memorial Hospital, a university-affiliated hospital in Northern Taiwan, were evaluated. Chest surgeon were routinely consulted to evaluate feasibility of silicon stent placement in benign airway obstruction. All patients in our study were those unsuitable to receive silicon stent placement.
Who may be able to join
- age > 18 years,
- benign tracheal obstruction,
- receive Ultraflex metallic stent placement under flexible bronchoscopy.
Who cannot join
- malignant diseases,
- feasibility to receive surgical treatment or silicon stent placement.
Trial locations and contacts
1 site in 1 country.
About this study
This study is aimed to determine factors leading to obstructive granulation tissue formation after placement of Self-Expandable Metallic Stent (SEMS) in patients with benign tracheal diseases.
Read the detailed description
From August 2001 to September 2007, patients with benign tracheal stenosis who underwent endoscopic tracheal stent placements at the Chang Gung Memorial Hospital, a university-affiliated hospital in Northern Taiwan, were evaluated.
Definition of airway conditions Dynamic collapse (tracheao-malacia) was defined as tracheal lumen narrowing on expiration under bronchoscopic examination. Structural tracheal stenosis was defined as tracheal stenosis excluding dynamic collapse. Etiologies of structural tracheal stenosis were post-intubation or tracheostomy, post-tuberculosis infection, granulation tissue formation cause previous SEMS re-stenosis, previous SEMS fracture, corrosive injury with stricture, mediastinitis cause airway stricture, and goiter compression.
Obstructive granulation tissue formation after SEMS implantation was defined as granulation tissue obstructing the lumen of the SEMS under bronchoscopic examination, including the proximal and distal ends.
Significant variables, such as structural obstruction airway before SEMS implantation was entered into a forward logistical regression analysis to determine the net effect of each predictor while controlling the net effects of others to obstructive granulation tissue formation. Obstructive granulation tissue formation curves between patients with and those without structural tracheal stenosis before SEMS implantation were compared by log rank test.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- granulation tissue, benign, tracheal stenosis, ultraflex, COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Tracheal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Structural /dynamic airway obstruction | Obstructive granulation tissue formation after SEMS implantation was defined as granulation tissue obstructing the lumen of the SEMS under bronchoscopic examination. |
What is being measured
The primary outcome is the main question the study is designed to answer.
factors to obstructive granulation tissue formation
Measured: time from stent placement to granualtion tissue formation after metallic stent placement in benign tracheal obstruction.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2009 (estimated)
- Study startAug 2001
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Fu-Tsai Chung, Principal investigator, Department of Thoracic Medicine, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01006200
- Sponsor's protocol ID
- 97-1411B
- Status last verified
- Oct 2009
- First submitted
- 29 Oct 2009
- Last updated
- 2 Nov 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Madden BP, Stamenkovic SA, Mitchell P. Covered expandable tracheal stents in the management of benign tracheal granulation tissue formation. Ann Thorac Surg. 2000 Oct;70(4):1191-3. doi: 10.1016/s0003-4975(00)01555-1.
PubMed 11081868Lin SM, Lin TY, Chou CL, Chen HC, Liu CY, Wang CH, Lin HC, Yu CT, Lee KY, Kuo HP. Metallic stent and flexible bronchoscopy without fluoroscopy for acute respiratory failure. Eur Respir J. 2008 May;31(5):1019-23. doi: 10.1183/09031936.00099507. Epub 2008 Jan 9.
PubMed 18184680Kuo CH, Lin SM, Chen HC, Chou CL, Yu CT, Kuo HP. Diagnosis of peripheral lung cancer with three echoic features via endobronchial ultrasound. Chest. 2007 Sep;132(3):922-9. doi: 10.1378/chest.06-3106. Epub 2007 Jul 23.
PubMed 17646234
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors to Obstructive Granulation Tissue Formation After Ultraflex Stenting in Benign Tracheal Narrowing
- ClinicalTrials.gov ID
- NCT01006200
- Acronym / sponsor ID
- 97-1411B
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- granulation tissue, benign, tracheal stenosis, ultraflex, COPD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Aug 2001
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 2 Nov 2009 (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.
This study is aimed to determine factors leading to obstructive granulation tissue formation after placement of Self-Expandable Metallic Stent (SEMS) in patients with benign tracheal diseases.
Detailed description
From August 2001 to September 2007, patients with benign tracheal stenosis who underwent endoscopic tracheal stent placements at the Chang Gung Memorial Hospital, a university-affiliated hospital in Northern Taiwan, were evaluated.
Definition of airway conditions Dynamic collapse (tracheao-malacia) was defined as tracheal lumen narrowing on expiration under bronchoscopic examination. Structural tracheal stenosis was defined as tracheal stenosis excluding dynamic collapse. Etiologies of structural tracheal stenosis were post-intubation or tracheostomy, post-tuberculosis infection, granulation tissue formation cause previous SEMS re-stenosis, previous SEMS fracture, corrosive injury with stricture, mediastinitis cause airway stricture, and goiter compression.
Obstructive granulation tissue formation after SEMS implantation was defined as granulation tissue obstructing the lumen of the SEMS under bronchoscopic examination, including the proximal and distal ends.
Significant variables, such as structural obstruction airway before SEMS implantation was entered into a forward logistical regression analysis to determine the net effect of each predictor while controlling the net effects of others to obstructive granulation tissue formation. Obstructive granulation tissue formation curves between patients with and those without structural tracheal stenosis before SEMS implantation were compared by log rank test.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Structural /dynamic airway obstruction | – | –Obstructive granulation tissue formation after SEMS implantation was defined as granulation tissue obstructing the lumen of the SEMS under bronchoscopic examination. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with benign tracheal stenosis who underwent endoscopic tracheal stent placements at the Chang Gung Memorial Hospital, a university-affiliated hospital in Northern Taiwan, were evaluated. Chest surgeon were routinely consulted to evaluate feasibility of silicon stent placement in benign airway obstruction. All patients in our study were those unsuitable to receive silicon stent placement.
Key inclusion criteria (3 listed)
- age > 18 years,
- benign tracheal obstruction,
- receive Ultraflex metallic stent placement under flexible bronchoscopy.
Key exclusion criteria (2 listed)
- malignant diseases,
- feasibility to receive surgical treatment or silicon stent placement.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
factors to obstructive granulation tissue formation
Time frame: time from stent placement to granualtion tissue formation after metallic stent placement in benign tracheal obstruction.
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 2 Nov 2009.
- Background: PubMed 11081868Madden BP, Stamenkovic SA, Mitchell P. Covered expandable tracheal stents in the management of benign tracheal granulation tissue formation. Ann Thorac Surg. 2000 Oct;70(4):1191-3. doi: 10.1016/s0003-4975(00)01555-1.
- Background: PubMed 18184680Lin SM, Lin TY, Chou CL, Chen HC, Liu CY, Wang CH, Lin HC, Yu CT, Lee KY, Kuo HP. Metallic stent and flexible bronchoscopy without fluoroscopy for acute respiratory failure. Eur Respir J. 2008 May;31(5):1019-23. doi: 10.1183/09031936.00099507. Epub 2008 Jan 9.
- Background: PubMed 17646234Kuo CH, Lin SM, Chen HC, Chou CL, Yu CT, Kuo HP. Diagnosis of peripheral lung cancer with three echoic features via endobronchial ultrasound. Chest. 2007 Sep;132(3):922-9. doi: 10.1378/chest.06-3106. Epub 2007 Jul 23.
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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.
Fu-Tsai Chung principal investigator
Department of Thoracic Medicine, Chang Gung Memorial Hospital
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 Chronic Obstructive Pulmonary Disease, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 3 inclusion and 2 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 2 Nov 2009. 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 Taiwan. 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?
factors to obstructive granulation tissue formation (time frame: time from stent placement to granualtion tissue formation after metallic stent placement in benign tracheal obstruction.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01006200, which also lists 3 linked publications.
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 2 Nov 2009.