Comparison of the results of pleurodesis treatment with 50% glucose with pleurodesis with bleomycin in patients with malignant pleural effusion referring to educational centers
The practical purpose of this study was to determine a safe and less complicated and cost-effective treatment method for the treatment of pleurisy in patients with malignant pleural effusion.
Design
A clinical trial with a control group with a parallel simple double-blind randomized phase group of phase 3 on 64 patients.
Settings and conduct
Admitted patients with malignant pleural effusion in Isfahan medical sciences hospitals, including Al-Zahra, Seyed Al-Shohada, Amin and ...
Double blind so that:
In this study, the order is written by the professor as *pleurodesis No. 1 * and * pleurodesis No. 2 *, and only the executing nurses were aware of this formula, and the relevant assistant for the execution is unaware of the drug being injected into the chest.
Participants/Inclusion and exclusion criteria
Patient with metastatic malignancies cause to pleural effusion.
Diagnosis of malignant pleural effusion based on pleural fluid cytology.
Symptomatic and recurrent pleural effusion due to malignancy.
History of lung diseases such as COPD, sclerotherapy
Hypersensitivity to bleomycin
Intervention groups
One group for pleurodesis uses bleomycin and one group for pleurodesis uses 50% glucose.کار
Main outcome variables
Age; Gender; The type of material used in Plourdes; Time required to hold the chest tube; Time of hospitalization of patients; Postoperative complications of pleurisy with bleomycin; Recurrent pleural effusion; Symptoms of patients after pleurisy with bleomycin; Plovers success rate; Frequent injection of 50% glucose or bleomycin in Plordes.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201013049017N1
Registration date:2021-02-12, 1399/11/24
Registration timing:registered_while_recruiting
Last update:2021-02-12, 1399/11/24
Update count:0
Registration date
2021-02-12, 1399/11/24
Registrant information
Name
Hamid Talebzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3620 1995
Email address
talebzadeh.h@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2021-05-22, 1400/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the results of pleurodesis treatment with 50% glucose with pleurodesis with bleomycin in patients with malignant pleural effusion referring to educational centers
Public title
Pleurodesis treatment with 50% glucose
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient with metastatic malignancies cause to pleural effusion.
Diagnosis of malignant pleural effusion based on pleural fluid cytology.
Symptomatic and recurrent pleural effusion due to malignancy.
No history of allergy to bleomycin .
Exclusion criteria:
Reluctance to participate in the study
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Using the Convenience Sampling method, 64 eligible individuals were selected and then assigned to groups A and B using a 4-item randomized block method. For this purpose, in blocks of 4, two allocations to group A and two allocations to group B were considered and there were a total of 6 cases. The four blocks created were selected so that the sample size reached 64 people. In order to conceal random allocation, the method of opaque sealed envelopes with the random sequence was used. In this method, first, a random sequence is created by one of the mentioned methods, and based on the sample size of the research, a number of opaque envelopes are prepared and each of the random sequences created is recorded on a card and the cards are inside the envelopes. Were placed in order. At the time of enrollment, one of the envelopes was opened and the assigned group was revealed in order of eligible participants.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the order is written by the professor as * pleurodesis No. 1 * and * pleurodesis No. 2 *, and only the performing nurses were aware of this formula, and the relevant assistant for the execution is unaware of the drug being injected into the chest.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Esfahan University of Medical Sciences
Street address
No. 4, Hezar Jerib St., Isfahan University of Medical Sciences and Health Services- Vice Chancellor for Research and Technology,Isfahan, Iran.
City
Esfahan
Province
Isfehan
Postal code
۷۳۴۶۱۸۱۷۴۶
Approval date
2020-03-11, 1398/12/21
Ethics committee reference number
IR.MUI.MED.REC.1398.712
Health conditions studied
1
Description of health condition studied
Malignant pleural effusion
ICD-10 code
J91.0
ICD-10 code description
Malignant pleural effusion
Primary outcomes
1
Description
Investigation of the location and severity of pleural effusion
Timepoint
Before starting the intervention: Installation of chest tube number F 28 in the area of the hypothetical middle axillary line from the fifth or sixth intercostal space in the appropriate position24 to 48 hours after chest tube implantation: Preparation of chest graph in both face and profile positions
Method of measurement
CT-Scan
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group (A): There are 32 people in this group. the solution containing 200 cc of 50% glucose and 12.5 ml of 2% lidocaine is injected into the pleural cavity through the chest tube between the teeth, injected and the chest tube for 2 hours. It is recommended that they change their position every 15 minutes for the first 2 hours. If the chest radiograph after pleurodesis shows satisfactory lung dilation and less than 100 ml of 24-hour drainage without air leakage, the patient's chest tube is removed and the patient is discharged. Patients will be referred for follow-up immediately after pleurodesis and after removal of the Chest Tube and then at one-month intervals for 3 months. At each visit, patients are evaluated for clinical signs and symptoms associated with pleural effusion, including shortness of breath, cough, chest pain, and pulmonary sounds, followed by chest radiographs in the first and second months, and The third will be performed after pleurisy and the patients' recovery will be evaluated.
Category
Treatment - Drugs
2
Description
Intervention group(B): In this group is 32 people Plunders solution containing 12.5 cc of lidocaine 2 ٪ is mixed with 50 cc of normal saline and bleomycin (1 mg / kg) and injected into the Chest Tube using a 50 cc syringe and then for Clamps for 2 hours.It is recommended that they change their position every 15 minutes for the first 2 hours.If the chest radiograph after pleurodesis shows satisfactory lung dilation and less than 100 ml of 24-hour drainage without air leakage, the patient's chest tube is removed and the patient is discharged.Patients will be referred for follow-up immediately after pleurodesis and after removal of the Chest Tube and then at one-month intervals for 3 months.At each visit, patients are evaluated for clinical signs and symptoms associated with pleural effusion, including shortness of breath, cough, chest pain, and pulmonary sounds, followed by chest radiographs in the first and second months, and The third will be performed after pleurisy and the patients' recovery will be evaluated.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Al Zahra University Hospital
Full name of responsible person
Hamid Talebzadeh
Street address
Al Zahra Educational and Medical Center, Soffe Blvd., Esfahan, Iran.
City
Esfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 0048
Email
talebzadeh.h@med.mui.ac.ir
2
Recruitment center
Name of recruitment center
Seyed Al-Shohada Teaching Hospital (Omid)
Full name of responsible person
Hamid Talebzadeh
Street address
Farshadi Alley, Khayam St., Isfahan, Iran
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
talebzadeh.h@med.mui.ac.ir
3
Recruitment center
Name of recruitment center
Kashani Teaching Hospital
Full name of responsible person
Hamid Talebzadeh
Street address
Ayatollah Kashani Main Street., Ayatollah Kashani Hospital., Isfahan, Iran.
City
Esfahan
Province
Isfehan
Postal code
۸۳۴۳۴۸۱۸۳۹
Phone
+98 31 3668 0048
Email
talebzadeh.h@med.mui.ac.ir
4
Recruitment center
Name of recruitment center
Amin Teaching Hospital
Full name of responsible person
Hamid Talebzadeh
Street address
Ibn Sina St., Sanbolistan Alley, Amin Hospital, Isfahan, Iran.
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
talebzadeh.h@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shagayegh Hagh Jooi Javanmard
Street address
Hezar Jerib street, Isfahan University Of Medical Sciences, Isfahan, Iran
City
Esfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۶۱
Phone
+98 31 3368 8138
Email
sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
hamid talebzadeh
Position
Associated professor of thoracic surgeon
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
No.14, Motahhari St., South Saeb St., Marnan Square to the end of Khayyam St., Zayandehrud Building. Isfahan, Iran
City
Esfahan
Province
Isfehan
Postal code
8185675581
Phone
+98 31 3237 8758
Email
talebzadeh.h@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Milad Nazari sabet
Position
General Surgical Assistant
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
No.14, Motahhari St., South Saeb St., Marnan Square to the end of Khayyam St., Zayandehrud Building, Isfahan, Iran
City
Esfahan
Province
Isfehan
Postal code
8185675581
Phone
+98 31 3237 8758
Email
miladnazarisabet64@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Milad Nazari sabet
Position
General Surgical Assistant
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
No. 14, Motahhari St., South Saeb St., Marnan Square to the end of Khayyam St., Zayandehrud Building, Isfahan, Iran
City
Esfahan
Province
Isfehan
Postal code
8185675581
Phone
+98 31 3237 8758
Email
miladnazarisabet64@gmail.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
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