Study of Interventional Pulmonologic Treatment of Malignant Central Airway Stricture

November 20, 2014 updated by: Tang-Du Hospital

Prospective, Open, Multicenter Study of Interventional Pulmonologic Treatment of Malignant Central Airway Stricture

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710038
        • Tangdu Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: cryotherapy
give the cases whose central airway stricture were caused by soft neoplasm tissues cryotherapy
Procedure: cryotherapy
use cryotherapy to delete soft neoplasm tissue in the airway
Experimental: argon plasma coagulation
give the cases whose central airway stricture were caused by hard neoplasm tissues argon plasma coagulation
Procedure: argon plasma coagulation
use argon plasma coagulation to delete hard neoplasm tissue in the airway
Experimental: stent
give the cases whose central airway stricture were caused by neoplasm compression stent placement
Procedure: stent placement
use stent placement to open the airway compressed by out neoplasm
Experimental: snare
give the cases whose central airway stricture were caused by polypoid neoplasm tissues snare
Procedure: deletion tumor tissue by snare
use snare to delete polypoid neoplasm tissue in the airway

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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.

Investigators

  • Principal Investigator: Faguang Jin, Ph.D, Tang-Du Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

October 26, 2014

First Submitted That Met QC Criteria

November 20, 2014

First Posted (Estimate)

November 24, 2014

Study Record Updates

Last Update Posted (Estimate)

November 24, 2014

Last Update Submitted That Met QC Criteria

November 20, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAO-NO.201402024-malignant1
  • NO.201402024 (Other Grant/Funding Number: Special Fund for Scientific Research in the Public Welfare)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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