search
Back to results

Study of Interventional Pulmonologic Treatment of Malignant Central Airway Stricture

Primary Purpose

Airway Obstruction

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
cryotherapy
argon plasma coagulation
stent placement
deletion tumor tissue by snare
Sponsored by
Tang-Du Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Airway Obstruction focused on measuring neoplasm, central airway, obstruction

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tangdu Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

cryotherapy

argon plasma coagulation

stent

snare

Arm Description

give the cases whose central airway stricture were caused by soft neoplasm tissues cryotherapy

give the cases whose central airway stricture were caused by hard neoplasm tissues argon plasma coagulation

give the cases whose central airway stricture were caused by neoplasm compression stent placement

give the cases whose central airway stricture were caused by polypoid neoplasm tissues snare

Outcomes

Primary Outcome Measures

percentage of the cases that got Ⅰand Ⅱlevel remission

Secondary Outcome Measures

the values of dyspnea index
Karnofsky Physical scales

Full Information

First Posted
October 26, 2014
Last Updated
November 20, 2014
Sponsor
Tang-Du Hospital
Collaborators
Changhai Hospital, The First Affiliated Hospital of Guangzhou Medical University, Xinqiao Hospital of Chongqing, China Meitan General Hospital, Micro-Tech (Nanjing) Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT02299830
Brief Title
Study of Interventional Pulmonologic Treatment of Malignant Central Airway Stricture
Official Title
Prospective, Open, Multicenter Study of Interventional Pulmonologic Treatment of Malignant Central Airway Stricture
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Unknown status
Study Start Date
December 2014 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tang-Du Hospital
Collaborators
Changhai Hospital, The First Affiliated Hospital of Guangzhou Medical University, Xinqiao Hospital of Chongqing, China Meitan General Hospital, Micro-Tech (Nanjing) Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Airway Obstruction
Keywords
neoplasm, central airway, obstruction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
cryotherapy
Arm Type
Experimental
Arm Description
give the cases whose central airway stricture were caused by soft neoplasm tissues cryotherapy
Arm Title
argon plasma coagulation
Arm Type
Experimental
Arm Description
give the cases whose central airway stricture were caused by hard neoplasm tissues argon plasma coagulation
Arm Title
stent
Arm Type
Experimental
Arm Description
give the cases whose central airway stricture were caused by neoplasm compression stent placement
Arm Title
snare
Arm Type
Experimental
Arm Description
give the cases whose central airway stricture were caused by polypoid neoplasm tissues snare
Intervention Type
Procedure
Intervention Name(s)
cryotherapy
Intervention Description
use cryotherapy to delete soft neoplasm tissue in the airway
Intervention Type
Procedure
Intervention Name(s)
argon plasma coagulation
Intervention Description
use argon plasma coagulation to delete hard neoplasm tissue in the airway
Intervention Type
Procedure
Intervention Name(s)
stent placement
Intervention Description
use stent placement to open the airway compressed by out neoplasm
Intervention Type
Procedure
Intervention Name(s)
deletion tumor tissue by snare
Intervention Description
use snare to delete polypoid neoplasm tissue in the airway
Primary Outcome Measure Information:
Title
percentage of the cases that got Ⅰand Ⅱlevel remission
Time Frame
the next day after the treatment
Secondary Outcome Measure Information:
Title
the values of dyspnea index
Time Frame
the next day after the treatment
Title
Karnofsky Physical scales
Time Frame
the next day after the treatment
Other Pre-specified Outcome Measures:
Title
adverse event during the treatment
Time Frame
from the beginning of the treatment to 48 hours after the treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Deguang Mu, Ph.D
Phone
86-29-777825
Email
deguang@fmmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Yandong Nan, MD
Phone
86-29-84717533
Email
nanyandong2008@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Faguang Jin, Ph.D
Organizational Affiliation
Tang-Du Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tangdu Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710038
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deguang Mu, Ph.D
Phone
86-29-84777825
Email
deguang@fmmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Deguang Mu, Ph.D

12. IPD Sharing Statement

Learn more about this trial

Study of Interventional Pulmonologic Treatment of Malignant Central Airway Stricture

We'll reach out to this number within 24 hrs