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

NCT ID: NCT01006200

Last Updated: 2009-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

67 participants

Study Classification

OBSERVATIONAL

Study Start Date

2001-08-31

Study Completion Date

2007-09-30

Brief Summary

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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

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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

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Chronic Obstructive Pulmonary Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Department of Thoracic Medicine, Chang Gung Memorial Hospital

Principal Investigators

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Fu-Tsai Chung

Role: PRINCIPAL_INVESTIGATOR

Department of Thoracic Medicine, Chang Gung Memorial Hospital

Locations

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Chang Gung Memorial Hospital

Taipei, Taipei, Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type BACKGROUND
PMID: 11081868 (View on PubMed)

Lin 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.

Reference Type BACKGROUND
PMID: 18184680 (View on PubMed)

Kuo 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.

Reference Type BACKGROUND
PMID: 17646234 (View on PubMed)

Other Identifiers

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97-1411B

Identifier Type: -

Identifier Source: org_study_id

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