NCT02299830

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2014

Completed
29 days until next milestone

First Posted

Study publicly available on registry

November 24, 2014

Completed
7 days until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

November 24, 2014

Status Verified

November 1, 2014

Enrollment Period

3 years

First QC Date

October 26, 2014

Last Update Submit

November 20, 2014

Conditions

Airway Obstruction

Keywords

neoplasmcentral airwayobstruction

Outcome Measures

Primary Outcomes (1)

  • percentage of the cases that got Ⅰand Ⅱlevel remission

    the next day after the treatment

Secondary Outcomes (2)

  • the values of dyspnea index

    the next day after the treatment

  • Karnofsky Physical scales

    the next day after the treatment

Other Outcomes (1)

  • adverse event during the treatment

    from the beginning of the treatment to 48 hours after the treatment

Study Arms (4)

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

cryotherapyPROCEDURE

use cryotherapy to delete soft neoplasm tissue in the airway

cryotherapy
argon plasma coagulationPROCEDURE

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

argon plasma coagulation
stent placementPROCEDURE

use stent placement to open the airway compressed by out neoplasm

stent
deletion tumor tissue by snarePROCEDURE

use snare to delete polypoid neoplasm tissue in the airway

snare

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tangdu Hospital

Xi'an, Shaanxi, 710038, China

Location

MeSH Terms

Conditions

Airway ObstructionNeoplasmsBites and Stings

Interventions

CryotherapyArgon Plasma Coagulation

Condition Hierarchy (Ancestors)

Respiratory InsufficiencyRespiration DisordersRespiratory Tract DiseasesPoisoningChemically-Induced DisordersWounds and Injuries

Intervention Hierarchy (Ancestors)

TherapeuticsElectrocoagulationCauteryHemostatic TechniquesAblation TechniquesSurgical Procedures, OperativeHemostasis, Surgical

Study Officials

  • Faguang Jin, Ph.D

    Tang-Du Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Deguang Mu, Ph.D

CONTACT

86-29-777825deguang@fmmu.edu.cn

Yandong Nan, MD

CONTACT

86-29-84717533nanyandong2008@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2014

First Posted

November 24, 2014

Study Start

December 1, 2014

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

November 24, 2014

Record last verified: 2014-11

Locations

CN(1)