Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01006200
Enrollment
67
Registered
2009-11-02
Start date
2001-08-31
Completion date
2007-09-30
Last updated
2009-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

granulation tissue, benign, tracheal stenosis, ultraflex, COPD

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.

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.

Interventions

None listed

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
factors to obstructive granulation tissue formationtime from stent placement to granualtion tissue formation after metallic stent placement in benign tracheal obstruction.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026