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

This study has been completed.
Sponsor:
Information provided by:
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01006200
First received: October 29, 2009
Last updated: October 30, 2009
Last verified: October 2009
  Purpose

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
Chronic Obstructive Pulmonary Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Factors to Obstructive Granulation Tissue Formation After Ultraflex Stenting in Benign Tracheal Narrowing

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • factors to obstructive granulation tissue formation [ Time Frame: time from stent placement to granualtion tissue formation after metallic stent placement in benign tracheal obstruction. ] [ Designated as safety issue: Yes ]

Enrollment: 67
Study Start Date: August 2001
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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
Study First Received: October 29, 2009
Last Updated: October 30, 2009
Health Authority: Taiwan: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on July 28, 2014