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

Sponsor
Chang Gung Memorial Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01006200
Collaborator
(none)
67
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73
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Study Details

Study Description

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 Intervention/Treatment Phase

    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

    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 :
    Aug 1, 2001
    Actual Primary Completion Date :
    Sep 1, 2007
    Actual Study Completion Date :
    Sep 1, 2007

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. factors to obstructive granulation tissue formation [time from stent placement to granualtion tissue formation after metallic stent placement in benign tracheal obstruction.]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01006200
    Other Study ID Numbers:
    • 97-1411B
    First Posted:
    Nov 1, 2009
    Last Update Posted:
    Nov 1, 2009
    Last Verified:
    Oct 1, 2009

    Study Results

    No Results Posted as of Nov 1, 2009