NCT02287389

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of four interventional pulmonology techniques for the treatment of fibrotic central airway stricture. The four techniques are：

  • balloon dilation
  • balloon dilation plus cryotherapy
  • balloon dilation plus spiculiform electrosurgery
  • balloon dilation plus mitomycin C injection

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
160

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
15 days until next milestone

First Posted

Study publicly available on registry

November 10, 2014

Completed
21 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 10, 2014

Status Verified

November 1, 2014

Enrollment Period

3 years

First QC Date

October 26, 2014

Last Update Submit

November 7, 2014

Conditions

Obstructive Airway Disease

Outcome Measures

Primary Outcomes (1)

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

    3 months

Secondary Outcomes (2)

  • the values of dispnea index

    3 months

  • Karnofsky Physical scales

    3 months

Other Outcomes (1)

  • adverse event during the treatment

    3 months

Study Arms (4)

balloon dilation

EXPERIMENTAL

give the cases balloon dilation as the intervention

Device: balloon dilation

balloon dilation plus cryotherapy

EXPERIMENTAL

give the cases balloon dilation plus cryotherapy as the intervention

Device: balloon dilationProcedure: cryotherapy

BD plus spiculiform electrosurgery

EXPERIMENTAL

give the cases balloon dilation plus spiculiform electrosurgery as the intervention

Device: balloon dilationProcedure: spiculiform electrosurgery

BD plus mitomycin C

EXPERIMENTAL

give the cases Balloon dilation plus mitomycin C as the intervention

Device: balloon dilationDrug: mitomycin C

Interventions

balloon dilationDEVICE
BD plus mitomycin CBD plus spiculiform electrosurgeryballoon dilationballoon dilation plus cryotherapy
cryotherapyPROCEDURE
balloon dilation plus cryotherapy
spiculiform electrosurgeryPROCEDURE
BD plus spiculiform electrosurgery
mitomycin CDRUG
BD plus mitomycin C

Eligibility Criteria

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

You may qualify if:

  • tracheal incision,intubation or bronchial tuberculosis caused central airway fibrotic stenosis
  • the degree of stenosis is above 50%
  • estimated survival duration is longer than 3 months
  • recieved 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 fibrotic 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

Lung Diseases, Obstructive

Interventions

CryotherapyMitomycin

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsMitomycinsIndolequinonesQuinonesOrganic ChemicalsAzirinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Faguang Jin, PhD

    Tang-Du Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Deguang Mu, PhD

CONTACT

86-29-84777825deguang@fmmu.edu.cn

Yandong Nan, MD

CONTACT

86-29-84717533nanyandong2008@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
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 10, 2014

Study Start

December 1, 2014

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

November 10, 2014

Record last verified: 2014-11

Locations

CN(1)