Effect of pleurodesis with negative pressure suction plus bleomycin in malignant pleural effusions
Design
Before and after interventional study , without control group, without randomization, without blindness
Settings and conduct
In patients with malignant pleural effusion referring to Shahid Sadoughi hospital of Yazd, who have been studied not randomly and without blindness, 15 ml of lidocaine 2% with 1 mg/kg bleomycin is injected. Before intervention and four weeks later, a simple decubitus chest x-ray is taken and the amount of malignant pleural effusion is measured and compared with the amount of pleural effusion before the chest tube and pleurodesis are compared with bleomycin with suction using 20cmH2O negative pressure.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Cytologically confirmed malignant pleural fluid, No sensitivity to bleomycin, No history of previous chemotherapy with bleomycin
Exclusion criteria: Previous history of pleurodesis, History of coagulation disorders, Patient dissatisfaction
Intervention groups
In patients with malignant pleural effusion, 15 ml of lidocaine 2% is injected into the chest tube, and bleomycin 1 mg/kg is injected into the chest tube with 50 ml normal saline to be diluted. Then the clamp is released and an hour later, the clamp is opened and lung fluid is pulled out using 20cmH2O negative pressure.
Main outcome variables
The amount of pleural effusion
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180813040779N1
Registration date:2018-08-26, 1397/06/04
Registration timing:prospective
Last update:2018-08-26, 1397/06/04
Update count:0
Registration date
2018-08-26, 1397/06/04
Registrant information
Name
Masoud Rahimian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3822 4000
Email address
m.rahimian@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of success rate of pleurodesis with negative pressure suction and bleomycin in malignant pleural effusions
Public title
Effect of pleurodesis and bleomycin in malignant pleural effusions
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Cytologically confirmed malignant pleural fluid
No sensitivity to bleomycin
No history of previous chemotherapy with bleomycin
Exclusion criteria:
Previous history of pleurodesis
History of coagulation disorders
Patient dissatisfaction
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
25
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yazd University of Medical Sciences
Street address
Shahid Sadughi hospital, Ghandi Blvd, Yazd
City
Yazd
Province
Yazd
Postal code
8944163114
Approval date
2017-07-02, 1396/04/11
Ethics committee reference number
IR.SSU.MEDICINE.REC.1396.264
Health conditions studied
1
Description of health condition studied
Pleural effusion
ICD-10 code
J90
ICD-10 code description
Pleural effusion, not elsewhere classified
Primary outcomes
1
Description
The amount of pleural effusion
Timepoint
Before the intervention and four weeks after the intervention
Method of measurement
Observation
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In patients with malignant pleural effusion, 15 ml of lidocaine 2% is injected into the chest tube, and bleomycin 1 mg/kg is injected into the chest tube with 50 ml normal saline to be diluted. Then the clamp is released and an hour later, the clamp is opened and lung fluid is pulled out using 20cmH2O negative pressure.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadughi hospital of Yazd
Full name of responsible person
Masoud Rahimian
Street address
Shahid Sadughi hospital, Ghandi Blvd, Yazd
City
Yazd
Province
Yazd
Postal code
8944163114
Phone
+98 35 3822 9007
Email
Sadoghi-hospital@ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Navid Nasirzadeh
Street address
Yazd University of Medial Sciences, Bahonar Square, Yazd
City
Yazd
Province
Yazd
Postal code
8916871967
Phone
+98 35 3725 8770
Email
nasirizadeh@iauyazd.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Masoud Rahimian
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Yazd University of Medical Sciences
City
Yazd
Province
Yazd
Postal code
8944163114
Phone
+98 35 3822 4000
Fax
Email
m.rahimian@ssu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Masoud Rahimian
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Yazd University of Medical Sciences
City
Yazd
Province
Yazd
Postal code
8944163114
Phone
+98 35 3822 4000
Fax
Email
m.rahimian@ssu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Masoud Rahimian
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Yazd University of Medical Sciences
City
Yazd
Province
Yazd
Postal code
8944163114
Phone
+98 35 3822 4000
Fax
Email
m.rahimian@ssu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
I will decide after collecting of all data
When the data will become available and for how long
Six months after publishing the results.
To whom data/document is available
All researchers
Under which criteria data/document could be used
With email request
From where data/document is obtainable
Masoud Rahimian
What processes are involved for a request to access data/document