Clinical trial NCT01006200: Factors to Obstructive Granulation Tissue Formation After Ultraflex Stenting in Benign Tracheal Narrowing
Official title: Factors to Obstructive Granulation Tissue Formation After Ultraflex Stenting in Benign Tracheal Narrowing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: granulation tissue
benign
tracheal stenosis
ultraflex
COPD
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2009-11-01
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility 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.

Primary outcomes:
measure: factors to obstructive granulation tissue formation
timeFrame: time from stent placement to granualtion tissue formation after metallic stent placement in benign tracheal obstruction.
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Department of Thoracic Medicine, Chang Gung Memorial Hospital
name: Fu-Tsai Chung
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.