Ignite Creation Date:
2025-12-26 @ 12:16 PM
Ignite Modification Date:
2025-12-29 @ 4:12 PM
Study NCT ID:
NCT01006200
Status:
COMPLETED
Last Update Posted:
2009-11-02
First Post:
2009-10-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Factors to Obstructive Granulation Tissue Formation After Ultraflex Stenting in Benign Tracheal Narrowing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D014135', 'term': 'Tracheal Stenosis'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014133', 'term': 'Tracheal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-10-30', 'studyFirstSubmitDate': '2009-10-29', 'studyFirstSubmitQcDate': '2009-10-30', 'lastUpdatePostDateStruct': {'date': '2009-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'factors to obstructive granulation tissue formation', 'timeFrame': 'time from stent placement to granualtion tissue formation after metallic stent placement in benign tracheal obstruction.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['granulation tissue', 'benign', 'tracheal stenosis', 'ultraflex', 'COPD'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'referencesModule': {'references': [{'pmid': '11081868', 'type': 'BACKGROUND', '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.'}, {'pmid': '18184680', 'type': 'BACKGROUND', '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.'}, {'pmid': '17646234', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nDefinition 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.\n\nObstructive 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.\n\nSignificant 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.\n\nChest 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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\> 18 years,\n* benign tracheal obstruction,\n* receive Ultraflex metallic stent placement under flexible bronchoscopy.\n\nExclusion Criteria:\n\n* malignant diseases,\n* feasibility to receive surgical treatment or silicon stent placement.'}, 'identificationModule': {'nctId': 'NCT01006200', 'briefTitle': 'Factors to Obstructive Granulation Tissue Formation After Ultraflex Stenting in Benign Tracheal Narrowing', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'Factors to Obstructive Granulation Tissue Formation After Ultraflex Stenting in Benign Tracheal Narrowing', 'orgStudyIdInfo': {'id': '97-1411B'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Structural /dynamic airway obstruction', 'description': 'Obstructive granulation tissue formation after SEMS implantation was defined as granulation tissue obstructing the lumen of the SEMS under bronchoscopic examination.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10507', 'city': 'Taipei', 'state': 'Taipei', 'country': 'Taiwan', 'facility': 'Chang Gung Memorial Hospital'}], 'overallOfficials': [{'name': 'Fu-Tsai Chung', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Thoracic Medicine, Chang Gung Memorial Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Fu-Tsai Chung', 'oldOrganization': 'Department of Thoracic Medicine, Chang Gung Memorial Hospital'}}}}