Study of Interventional Pulmonologic Treatment of Malignant Central Airway Stricture

NCT ID: NCT02299830

Last Updated: 2014-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2017-12-31

Brief Summary

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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

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Conditions

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Airway Obstruction

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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cryotherapy

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

Group Type EXPERIMENTAL

cryotherapy

Intervention Type PROCEDURE

use cryotherapy to delete soft neoplasm tissue in the airway

argon plasma coagulation

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

Group Type EXPERIMENTAL

argon plasma coagulation

Intervention Type PROCEDURE

use argon plasma coagulation to delete hard neoplasm tissue in the airway

stent

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

Group Type EXPERIMENTAL

stent placement

Intervention Type PROCEDURE

use stent placement to open the airway compressed by out neoplasm

snare

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

Group Type EXPERIMENTAL

deletion tumor tissue by snare

Intervention Type PROCEDURE

use snare to delete polypoid neoplasm tissue in the airway

Interventions

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cryotherapy

use cryotherapy to delete soft neoplasm tissue in the airway

Intervention Type PROCEDURE

argon plasma coagulation

use argon plasma coagulation to delete hard neoplasm tissue in the airway

Intervention Type PROCEDURE

stent placement

use stent placement to open the airway compressed by out neoplasm

Intervention Type PROCEDURE

deletion tumor tissue by snare

use snare to delete polypoid neoplasm tissue in the airway

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Changhai Hospital

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role collaborator

Xinqiao Hospital of Chongqing

OTHER

Sponsor Role collaborator

China Meitan General Hospital

OTHER

Sponsor Role collaborator

Micro-Tech (Nanjing) Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Tang-Du Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Faguang Jin, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Tang-Du Hospital

Locations

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Tangdu Hospital

Xi'an, Shaanxi, China

Site Status

Countries

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China

Central Contacts

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Deguang Mu, Ph.D

Role: CONTACT

86-29-777825

Yandong Nan, MD

Role: CONTACT

86-29-84717533

Facility Contacts

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Deguang Mu, Ph.D

Role: primary

86-29-84777825

Other Identifiers

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NO.201402024

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CAO-NO.201402024-malignant1

Identifier Type: -

Identifier Source: org_study_id