Study of Interventional Pulmonologic Treatment of Maligna... | NCT02299830

Studies
Study of Interventional Pulmonologic Treatment of Malignant Central Airway Stricture

NCT02299830

Sponsor

Tang-Du Hospital

Status

Unknown status

Last Update Posted

Nov 24, 2014Estimated

Enrollment

200Estimated

Phase

Not Applicable

Conditions

Airway Obstruction

Interventions

cryotherapy
argon plasma coagulation
stent placement
deletion tumor tissue by snare

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	National Health and Family Planning Commission

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 20, 2014

First Posted Date

Nov 24, 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 20, 2014

Last Update Posted Date

Nov 24, 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 malignant central airway stricture.

The four techniques are：

cryotherapy
argon plasma coagulation
stent
snare

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

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
cryotherapy	Experimental	give the cases whose central airway stricture were caused by soft neoplasm tissues cryotherapy	Procedure: cryotherapy
argon plasma coagulation	Experimental	give the cases whose central airway stricture were caused by hard neoplasm tissues argon plasma coagulation	Procedure: argon plasma coagulation
stent	Experimental	give the cases whose central airway stricture were caused by neoplasm compression stent placement	Procedure: stent placement
snare	Experimental	give the cases whose central airway stricture were caused by polypoid neoplasm tissues snare	Procedure: deletion tumor tissue by snare

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cryotherapy	Procedure	use cryotherapy to delete soft neoplasm tissue in the airway	cryotherapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
percentage of the cases that got Ⅰand Ⅱlevel remission		the next day after the treatment

Secondary Outcomes

Measure	Description	Time Frame
the values of dyspnea index		the next day after the treatment
Karnofsky Physical scales		the next day after the treatment

Other Outcomes

Measure	Description	Time Frame
adverse event during the treatment		from the beginning of the treatment to 48 hours after the treatment

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

malignant neoplasm caused central airway stenosis
the degree of stenosis is above 50%
estimated survival duration is longer than 3 months
received 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 malignant neoplasm caused central airway 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, Ph.D	Contact	86-29-777825		deguang@fmmu.edu.cn
Yandong Nan, MD	Contact	86-29-84717533		nanyandong2008@163.com

Overall Officials

Name	Affiliation	Role
Faguang Jin, Ph.D	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
D000402	Airway Obstruction
D009369	Neoplasms
D001733	Bites and Stings

Ancestor Terms

ID	Term
D012131	Respiratory Insufficiency
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D011041	Poisoning

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017679	Cryotherapy
D057908	Argon Plasma Coagulation

Ancestor Terms

ID	Term
D013812	Therapeutics
D004564	Electrocoagulation
D002425	Cautery
D006489	Hemostatic Techniques

Browse Leaves

Not provided

Browse Branches

Not provided