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Factors to Obstructive Granulation Tissue Formation After Ultraflex Stenting in Benign Tracheal Narrowing

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ClinicalTrials.gov Identifier: NCT01006200
Recruitment Status : Completed
First Posted : November 2, 2009
Last Update Posted : November 2, 2009
Sponsor:
Information provided by:
Chang Gung Memorial Hospital

Brief 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.

Condition or disease
Chronic Obstructive Pulmonary Disease

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 Type : Observational
Actual Enrollment : 67 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Factors to Obstructive Granulation Tissue Formation After Ultraflex Stenting in Benign Tracheal Narrowing
Study Start Date : August 2001
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Group/Cohort
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.



Primary Outcome Measures :
  1. factors to obstructive granulation tissue formation [ Time Frame: time from stent placement to granualtion tissue formation after metallic stent placement in benign tracheal obstruction. ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.

Criteria

Inclusion Criteria:

  • age > 18 years,
  • benign tracheal obstruction,
  • receive Ultraflex metallic stent placement under flexible bronchoscopy.

Exclusion Criteria:

  • malignant diseases,
  • feasibility to receive surgical treatment or silicon stent placement.

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): NCT01006200


Locations
Taiwan
Chang Gung Memorial Hospital
Taipei, Taiwan, 10507
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Principal Investigator: Fu-Tsai Chung Department of Thoracic Medicine, Chang Gung Memorial Hospital

Publications:
Responsible Party: Fu-Tsai Chung, Department of Thoracic Medicine, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01006200     History of Changes
Other Study ID Numbers: 97-1411B
First Posted: November 2, 2009    Key Record Dates
Last Update Posted: November 2, 2009
Last Verified: October 2009

Keywords provided by Chang Gung Memorial Hospital:
granulation tissue
benign
tracheal stenosis
ultraflex
COPD

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases