The aim of this study is to evaluate the results and complications of transbronchial lung biopsy with fluoroscopic guidance.
Design
two arm parallel group randomized without blinded procedure
Settings and conduct
this study will conduct among patients referred to bronchoscopy ward of Afzalipour Hospital that is a referral and university medical center in Kerman.
Participants/Inclusion and exclusion criteria
This randomized clinical trial will conduct on patients with pulmonary parenchymal lesions. all patients will be included the study unless patients with severe hypoxemia, severe asthma, hemodynamic instability, malignant arrhythmia and severe hemoptysis, who will be excluded.
Intervention groups
In control and subject groups ransbronchial lung biopsy were performed using fiberoptic bronchoscopy without fluoroscopic guidance and with fluoroscopic guidance respectively.
Main outcome variables
The pneumothorax rate, bleeding during transbronchial lung biopsy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150606022566N3
Registration date:2018-10-30, 1397/08/08
Registration timing:retrospective
Last update:2018-10-30, 1397/08/08
Update count:0
Registration date
2018-10-30, 1397/08/08
Registrant information
Name
Seyed Mehdi Hashemi Bajgani
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3211 8078
Email address
m_hashemi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-20, 1396/12/01
Expected recruitment end date
2018-09-22, 1397/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Diagnostic yield and Complications of Transbronchial Lung Biopsy with Fluoroscopic Guidance: A Randomized Clinical Trial
Public title
Transbronchial Lung Biopsy with Fluoroscopic Guidance
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
patients with pulmonary parenchymal lesions
Exclusion criteria:
patients with pulmonary parenchymal lesions with severe hypoxemia
patients with pulmonary parenchymal lesions with severe refractory asthma
patients with pulmonary parenchymal lesions with hemodynamic instability
patients with pulmonary parenchymal lesions with malignant arrhythmia
patients with pulmonary parenchymal lesions with severe hemoptysis
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be classified into two groups using random number table.
units of randomization is individuals.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
Afzalipour Hospital ,Imam Khomeini Highway,
City
Kerman
Province
Kerman
Postal code
7616914111
Approval date
2015-01-05, 1393/10/15
Ethics committee reference number
IR.KMU.REC.1393.340
Health conditions studied
1
Description of health condition studied
Parenchymal lung disease
ICD-10 code
J40, J41
ICD-10 code description
chronic lower respiratory diseases
Primary outcomes
1
Description
overall diagnosis of lesions
Timepoint
during bronchoscopy
Method of measurement
fiberoptic bronchoscop
2
Description
Pneumothorax rate
Timepoint
After Bronchoscopy
Method of measurement
Chest X-Ray
3
Description
Bleeding rate
Timepoint
After Bronchoscopy
Method of measurement
Chest X-Ray
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Transbronchial lung biopsy will perform using fiberoptic bronchoscopy under fluoroscopic–guidance
Category
Diagnosis
2
Description
Control group: Transbronchial lung biopsy will performed in control group using fiberoptic bronchoscopy without fluoroscopic–guidance
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipour Hospital
Full name of responsible person
Dr. Seyedmehdi Hashemi
Street address
,Afzalipour Hospital, Imam Highway
City
Kerman
Province
Kerman
Postal code
7616914111
Phone
+98 34 3132 8000
Email
hashemimehdi70@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Abbas Pardakhty
Street address
Jahad Blv.Vice chancellor for research,Kerman University of Medical Sciences
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3226 3855
Email
drpardakhty@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kerman University of Medical Sciences
Full name of responsible person
Dr. Seyed Mehdi hashemi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Afzalipour hospital, Imam Highway
City
Kerman
Province
Kerman
Postal code
7616914111
Phone
+98 34 3132 8000
Email
Hashemimehdi70@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr. Seyed Mehdi hashemi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Afzalipour hospital, Imam Highway
City
Kerman
Province
Kerman
Postal code
7616914111
Phone
+98 34 3132 8000
Email
Hashemimehdi70@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr. Seyed Mehdi hashemi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Afzalipour hospital, Imam Highway
City
Kerman
Province
Kerman
Postal code
7616914111
Phone
+98 34 3132 8000
Email
Hashemimehdi70@yahoo.com
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
Yes - There is 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
Title and more details about the data/document
all collected data are not shareable.
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
only available for people working in academic institutions
Under which criteria data/document could be used
all collected data are not shareable.
From where data/document is obtainable
all collected data are not shareable.
What processes are involved for a request to access data/document