Study of Interventional Pulmonologic Treatment of Benign... | NCT02287389

Studies
Study of Interventional Pulmonologic Treatment of Benign Central Airway Fibrotic Stricture

NCT02287389

Sponsor

Tang-Du Hospital

Status

Unknown status

Last Update Posted

Nov 10, 2014Estimated

Enrollment

160Estimated

Phase

Not Applicable

Conditions

Obstructive Airway Disease

Interventions

balloon dilation
cryotherapy
spiculiform electrosurgery
mitomycin C

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
NO.201402024	Other Grant/Funding Number	Special Fund for Scientific Research in the Public Welfare

Status Module

Record Verification Date

Nov 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2014

Primary Completion Date

Dec 2017Estimated

Completion Date

Dec 2017Estimated

First Submitted Date

Oct 26, 2014

First Submission Date that Met QC Criteria

Nov 7, 2014

First Posted Date

Nov 10, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 7, 2014

Last Update Posted Date

Nov 10, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

Tang-Du HospitalOTHER

Collaborators

Name	Class
Changhai Hospital	OTHER
The First Affiliated Hospital of Guangzhou Medical University	OTHER
Xinqiao Hospital of Chongqing	OTHER
China Meitan General Hospital

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

160Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
balloon dilation	Experimental	give the cases balloon dilation as the intervention	Device: balloon dilation
balloon dilation plus cryotherapy	Experimental	give the cases balloon dilation plus cryotherapy as the intervention	Device: balloon dilation Procedure: cryotherapy
BD plus spiculiform electrosurgery	Experimental	give the cases balloon dilation plus spiculiform electrosurgery as the intervention	Device: balloon dilation Procedure: spiculiform electrosurgery
BD plus mitomycin C	Experimental	give the cases Balloon dilation plus mitomycin C as the intervention	Device: balloon dilation Drug: mitomycin C

Interventions

Name	Type	Description	Arm Group Labels	Other Names
balloon dilation	Device		BD plus mitomycin C BD plus spiculiform electrosurgery balloon dilation balloon dilation plus cryotherapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
percentage of the cases that got Ⅰand Ⅱlevel remission		3 months

Secondary Outcomes

Measure	Description	Time Frame
the values of dispnea index		3 months
Karnofsky Physical scales		3 months

Other Outcomes

Measure	Description	Time Frame
adverse event during the treatment		3 months

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Deguang Mu, PhD	Contact	86-29-84777825		deguang@fmmu.edu.cn
Yandong Nan, MD	Contact	86-29-84717533		nanyandong2008@163.com

Overall Officials

Name	Affiliation	Role
Faguang Jin, PhD	Tang-Du Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tangdu Hospital		Xi'an	Shaanxi	710038	China

Condition Browse Module

MeSH Terms

ID	Term
D008173	Lung Diseases, Obstructive

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017679	Cryotherapy
D016685	Mitomycin

Ancestor Terms

ID	Term
D013812	Therapeutics
D008937	Mitomycins
D045563	Indolequinones
D011809	Quinones
D009930

Browse Leaves

Not provided

Browse Branches

Not provided