compare relative frequency of lymphedema after axillary reverse mapping by methylen blue or without methylen blue in breast neoplasm patients
Design
clinical trial with control groups, parallel groups , without blinding, not randomised with 160 patients
Settings and conduct
after injection of 1.0mCi unfiltered technetium sulfur colloid to all patients , attending to their clinical condition ,they were divided in 2 groups. one with methylene blue injection and one without injecting(only studying with gamma detector). blinding was not needed .
Participants/Inclusion and exclusion criteria
breast cancer , candidate for Sentinel Lymph Node Biopsy(SLNB) +Axillary Reverse Mapping(ARM) ±Axillary Lymph Node Dissection(ALND) , operable tumor
Intervention groups
in intervention group first methylen blue will be injected and using this coloring methode , sentinel lymph node will be detected and dissected and lymphedema incidence will be detected after that
in control group we do not inject methylen blue and sentinel lymph node will be detected just by using gamma detector and then dissected
Main outcome variables
breast cancer / independent
SLNB / dependent
ARM / dependent
ALND/ dependent
arm circumference / dependent
affected site / dependent
affected anatomical region / dependent
tumor size/ dependent
surgery duration/ dependent
number of dissected lymph nodes/ dependent
age / background
body mass index/background
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200909048672N1
Registration date:2020-12-06, 1399/09/16
Registration timing:retrospective
Last update:2020-12-06, 1399/09/16
Update count:0
Registration date
2020-12-06, 1399/09/16
Registrant information
Name
Reza ٍٍEshraghi samani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3668 0042
Email address
eshraghireza@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-21, 1398/01/01
Expected recruitment end date
2020-10-22, 1399/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparing Prevalence of lymphedema after Axillary Reverse Mapping by methylen blue or without methylen blue in patients with breast neoplasm
Public title
investigate Prevalence of lymphedema after breast neoplasm surgery
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
breast cancer
SLNB+ARM±ALND candidate
able to surgery
Exclusion criteria:
previous chemotherapy
previous radiotherapy
previous axilary surgery
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Not randomized
Randomization description
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
Ethical committee of Esfahan university of medical science
Street address
Hezar Jarib
City
Esfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-05-14, 1399/02/25
Ethics committee reference number
IR.MUI.MED.REC.1399.148
Health conditions studied
1
Description of health condition studied
breast cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast
2
Description of health condition studied
lymphedema
ICD-10 code
I97.2
ICD-10 code description
Postmastectomy lymphedema syndrome
Primary outcomes
1
Description
arm circumference
Timepoint
at the beginning and six month
Method of measurement
measuring with meter
Secondary outcomes
empty
Intervention groups
1
Description
first we inject methylen blue to patients in this group and with colored path that methylen blue makes , axillary lymph node mapping will be done. then using this mapping sentinel lymph node will be detected and dissected . prevalence of lymphedema will be measured after all this stages
Category
Diagnosis
2
Description
in this group we do not inject methylen blue and mapping will be done just by gamma detector . sentinel lymph node will be dissected and prevalence of lymphedema will be measured
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Seyed al Shohada Hospital
Full name of responsible person
Reza Eshraghi Samani
Street address
Motahari
City
Esfahan
Province
Isfehan
Postal code
8184917911
Phone
+98 31 3235 0210
Email
eshraghireza@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Beheshte Toghiani
Street address
Hezar Jarib
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8597
Email
dean@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
Reza Eshraghi Samani
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Hezar jarib ave, Esfahan University of Medical Science
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8597
Email
dean@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Reza Eshraghi Samani
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Hezarjarib ave , Isfahan university of medical science
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
0983136687597
Email
eshraghireza@med.mui.c.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hossein Ebrahimi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Hezarjarib ave , Isfahan university of medical science
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 9341
Email
hosseinebrahimimed@gmail.com
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
No - There is not 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
when all patients personal data become unrecognizable , all collected data will be published
When the data will become available and for how long
6 month after article published
To whom data/document is available
researchers work in scientific institues
Under which criteria data/document could be used
other scientific purposes
From where data/document is obtainable
reza eshraghi samani
What processes are involved for a request to access data/document
to recieve data , requester should send an email to dr esgrahi , then we will qualify his/her identity and verify his/her request (takes about 1 month) and send him/her requested data