Study of Interventional Pulmonologic Treatment of Benign Central Airway Fibrotic Stricture

Obstructive Airway Disease Clinical Trial

Official title:

Prospective, Randomized, Open, Controlled, Multicenter Stucy of Interventional Pulmonologic Treatment of Benign Central Airway Fibrotic Stricture

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02287389
• Other study ID #: CAO-NO.201402024-benign
• Secondary ID: NO.201402024
• Status: Not yet recruiting
• Phase: N/A
• First received: October 26, 2014
• Last updated: November 7, 2014
• Start date: December 2014
• Est. completion date: December 2017

Study information

• Verified date: November 2014
• Source: Tang-Du Hospital
• Contact: Deguang Mu, PhD
• Phone: 86-29-84777825
• Email: deguang[@]fmmu.edu.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of four interventional pulmonology techniques for the treatment of fibrotic central airway stricture.

The four techniques are：

• balloon dilation

• balloon dilation plus cryotherapy

• balloon dilation plus spiculiform electrosurgery

• balloon dilation plus mitomycin C injection

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• tracheal incision,intubation or bronchial tuberculosis caused central airway fibrotic stenosis

• the degree of stenosis is above 50%

• estimated survival duration is longer than 3 months

• recieved no treatment one month before

• can understand the statement informed consent

• agree to enroll in the study

Exclusion Criteria:

• older than 70 years or younger than 18 years

• not fibrotic stenosis

• not central airway stenosis

• existence of lumina collapse or twisting

• severe arrhythmia, myocardial ischemia or hypertensive crisis

• coagulation disorders

• existence of severe organ disfunction

• allergic to anesthesia drugs

• refuse to participate the study

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Diseases, Obstructive
• Obstructive Airway Disease

Intervention

Device:
• balloon dilation

Procedure:
• cryotherapy

• spiculiform electrosurgery

Drug:
• mitomycin C

Locations

Country	Name	City	State
China	Tangdu Hospital	Xi'an	Shaanxi

Sponsors (6)

Lead Sponsor	Collaborator
Tang-Du Hospital	Changhai Hospital, China Meitan General Hospital, Micro-Tech (Nanjing) Co., Ltd., The First Affiliated Hospital of Guangzhou Medical University, Xinqiao Hospital of Chongqing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	adverse event during the treatment		3 months	Yes
Primary	percentage of the cases that got ?and ?level remission		3 months	No
Secondary	the values of dispnea index		3 months	No
Secondary	Karnofsky Physical scales		3 months	No