Comparison of the Effectiveness of two treatment protocols of balloon dilatation and administration of methotrexate as an auxiliary treatment for patients with tracheal stenosis due to intubation
Comparison of two treatment protocols of balloon dilatation and administration of methotrexate as an auxiliary treatment for patients with tracheal stenosis due to intubation
Design
Two arm parallel group randomized trial with blinded postoperative care and outcome assessment
Settings and conduct
This clinical trial study will be performed on patients referred to bronchoscopy ward of Masih Daneshvari Hospital. Patients who have been diagnosed based on the results of their clinical examinations, spirometry and diagnostic bronchoscopy, will be included in the study and will be randomly divided into two groups. Patients in group 1 will undergo balloon dilatation. In the second group, methotrexate will be used every two weeks. Patients will be followed for the first month every week and then at 3 and 6 months.
Participants/Inclusion and exclusion criteria
The patients referred to the bronchoscopy ward of Masih Daneshvari Hospital who were diagnosed with the results of medical and paraclinical examinations will be included in the study and will be randomly divided into two groups. Obviously, only patients with tracheal stenosis after intubation will be included in the study and tracheal stenosis due to other reasons including congenital and primary and metastatic malignancies as well as vasculitis such as Wegener's disease will be excluded.
Intervention groups
Patients in group 1 undergo balloon dilatation and the second group receive methotrexate at a dose of 15 mg twice weekly for stenosis.
Main outcome variables
the length of stenosed section
severity of stenosis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170531034256N3
Registration date:2020-02-04, 1398/11/15
Registration timing:retrospective
Last update:2020-02-04, 1398/11/15
Update count:0
Registration date
2020-02-04, 1398/11/15
Registrant information
Name
Atefeh Abedini
Name of organization / entity
Chronic Respiratory Diseases Research Center, National Research Institute of Tuberculosis and Lung D
Country
Iran (Islamic Republic of)
Phone
+98 21 2712 2031
Email address
dr.abedini110@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-21, 1398/01/01
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
2019-03-21, 1398/01/01
Actual recruitment end date
2019-06-22, 1398/04/01
Trial completion date
2019-12-22, 1398/10/01
Scientific title
Comparison of the Effectiveness of two treatment protocols of balloon dilatation and administration of methotrexate as an auxiliary treatment for patients with tracheal stenosis due to intubation
Public title
Effect of two treatment protocols of balloon dilatation and administration of methotrexate in tracheal stenosis due to intubation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with a diagnosis according to the results of medical and paraclinical examinations
Patients with tracheal stenosis caused by intubation
Exclusion criteria:
congenital tracheal stenosis as well as tracheal stenosis are excluded.
Patients with tracheal stenosis due to primary or metastatic malignancies
Patients with tracheal stenosis due to vasculitis such as Wegener's disease
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
10
Actual sample size reached:
10
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly assigned to groups 1 or 2 , using a single computer-generated (nQuery Advisor) random number sequence by a physician.
Blinding (investigator's opinion)
Double blinded
Blinding description
A statistician will classify the patients using a single computer-generated (nQuery Advisor) random number sequence in either group one (control group) or group 2 (intervention group). This person is unaware of the type of treatment which they will receive in each group. Patients will be informed about two potential types of treatment but they won't know they will receive which of those.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid B
Street address
Masih Daneshvari Hospital, DAR ABAD
City
Tehran
Province
Tehran
Postal code
19569-44413
Approval date
2020-01-21, 1398/11/01
Ethics committee reference number
IR.SBMU.NRITLD.REC.1398.084
Health conditions studied
1
Description of health condition studied
patients with tracheal stenosis due to intubation
ICD-10 code
J39.8
ICD-10 code description
Other specified diseases of upper respiratory tract
Primary outcomes
1
Description
Need for surgical treatment at follow-up
Timepoint
Every week in the first month- month 3- month 6
Method of measurement
Physician diagnosis
Secondary outcomes
1
Description
side effects
Timepoint
every week in the first month- month 3- month 6
Method of measurement
Interview - Examination
Intervention groups
1
Description
Intervention group: Methotrexate will be used every two weeks and patients will be followed every week in the first month and then at month 3 and 6.
Category
Treatment - Drugs
2
Description
Control group: They will undergo local anesthesia and sedation and then bronchoscopy immediately before performing the dilatation balloon, with the aim of determining the location of the stenosis and designing the protocol for the patients. After the last balloon dilation, patients will be monitored for 2-4 hours.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Bronchoscopy Department of Masih Daneshvari Hospital
Full name of responsible person
Atefeh Abedini
Street address
Masih Daneshvari Hospital, Dar Abad
City
Tehran
Province
Tehran
Postal code
19569-44413
Phone
+98 21 2712 2031
Email
dr.abedini110@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Masih Daneshvari hospital, Dar Abad
City
tehran
Province
Tehran
Postal code
19569-44413
Phone
+98 21 8820 0096
Email
zarghi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Negar Bandegani
Position
General Practitioner-Researcher
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Masih Daneshvari Hospital, Darabad Avenue
City
Tehran
Province
Tehran
Postal code
19569-44413
Phone
+98 21 2712 2031
Email
Fatemehrazavi@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Arda Kiani
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Masih Daneshvari Hospital, dar abad
City
tehran
Province
Tehran
Postal code
19569-44413
Phone
+98 21 2712 2031
Email
ardakiani@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Atefeh Abedini
Position
assistance professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Masih Daneshvari Hospital, Darabad Avenue
City
tehran
Province
Tehran
Postal code
19569-44413
Phone
+98 21 2712 2031
Email
dr.abedini110@sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available