Comparison of pain, bleeding and pneumothorax between two sono guided liver biopsy approaches ( intercostal and subcostal)
Design
Patients with indication for liver biopsy randomizes by computerized codes in two groups ( intercostal and subcostal )
Settings and conduct
This study was performed in Imam Reza hospital (as a referal center in Mashhad).
Patients were randomized by computerized codes in two groups of subcostal and intercostal for liver biopsy and after local anesthesia liver biopsy was performed by skilled interventional radiologist and pain was estimated by VAS score in 0, 2 and 4 hours after biopsy. Bleeding by sonography and pneumothorax by checking of clinical symptoms (dyspnea) and if it was positive by CXR were evaluated .
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- clinical indications for liver biopsy
2- normal coagulation status
3- age > 18 Y/O
Exclusion criteria :
1- Patient's avoidance to sign informed consent.
2-Platelet level < 70000 or INR > 1.
3-interahepatic biliary duct dilatation
4- severe ascitis .
5- Impossibility of randomization due to patients' lesion conditions
6- Addiction to cigarette or other drugs .
Intervention groups
patients were randomized in two groups and our intervention , was type of biopsy approach ( subcostal and intercostal ) .
Main outcome variables
pain ; complications ( bleeding and pneumothorax)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180106038249N1
Registration date:2018-02-09, 1396/11/20
Registration timing:retrospective
Last update:2018-02-09, 1396/11/20
Update count:0
Registration date
2018-02-09, 1396/11/20
Registrant information
Name
Khaled Hashemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3321 3819
Email address
hashemirk931@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-01-20, 1394/10/30
Expected recruitment end date
2017-06-19, 1396/03/29
Actual recruitment start date
2016-01-20, 1394/10/30
Actual recruitment end date
2017-09-20, 1396/06/29
Trial completion date
empty
Scientific title
Comparison of pain and side effects between sono guided subcostal and intercostal approaches of liver biopsy
Public title
Comparison of pain and side effects (bleeding and pneumothorax) between subcostal and intercostal approaches of sono guided liver biopsy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Clinical indication for liver biopsy
Normal coagulation status
Age > 18 Y/O
Exclusion criteria:
Patient avoidance to sign informed consent
Platelet level < 70000 or INR>1.5
Intrahepatic biliary ducts dilatation
Severe acsitis
Impossibility of randomization due to patient's liver lesion conditions
Addiction to cigarette or other drugs
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
80
Actual sample size reached:
124
Randomization (investigator's opinion)
Randomized
Randomization description
Patients randomized in two groups ( subcostal and intercostal approach for sono guided liver biopsy) by computerized codes.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Patients did not have information about the approach of liver biopsy ( subcostal or intercostal) and data were given to statistical analyzer only by computerized codes without mention about biopsy approaches .
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Scinces
Street address
Imam Reza hospital, next to Imam Reza Square, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
۹۱۳۷۹۱۳۳۱۶
Approval date
2016-10-18, 1395/07/27
Ethics committee reference number
IR.MUMS.FM.REC.1395.295
Health conditions studied
1
Description of health condition studied
Pain management in liver biopsy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain score in Visual analogue scale
Timepoint
Pain measurement at 0, 2 and 4 hours after liver biopsy
Method of measurement
Visual analogue scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group , we use subcostal approach for doing liver biopsy.
Category
Rehabilitation
2
Description
Control group: In this group , we use intercostal approach for doing liver biopsy.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Radiology department of Imam Reza hospital
Full name of responsible person
Bita Abbasi
Street address
Radiology department, Imam Reza hospital, Next to Imam Reza square, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
AbbasiB@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi (MD)
Street address
Research administration of medical faculty, medical university of Mashhad, next to Azadi square, Vakil Abad Blvd, Mashhad, Iran
City
mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
TafaghodiM@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Bita Abbasi
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Radiology
Street address
Imam reza hospital , Next to Imam Reza square, Mashhad, Iran
City
mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
AbbasiB@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Bita Abbasi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Radiology
Street address
Imam reza hospital , Next to Imam Reza square, Mashhad, Iran
City
mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
AbbasiB@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Bita Abbasi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Radiology
Street address
Imam reza hospital , Next to Imam Reza square, Mashhad, Iran
City
mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
AbbasiB@mums.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
All data including Spilberger Questionnaire and VAS score and rate of complications can be announced.
When the data will become available and for how long
Six months after paper publication ( probably September 2017)
To whom data/document is available
Available for all people.
Under which criteria data/document could be used
After getting permission from reliable medical ethics committee, our data can be available.
From where data/document is obtainable
Dr. Bita Abbasi, Radiology assistant professor of Mashhad University of medical scinces.
E-mail address : AbbasiB@mums.ac.ir
Post address: Radiology department, Imam Reza Hospital , Imam reza square , Mashhad, Iran
Postal code : 9137913316
Telephone : +98 513 854 3031
What processes are involved for a request to access data/document
After evaluation of the request , up to two weeks data will be sent by e-mail.
Comments
Because our study was not about exact disease , ICD 10 code is undefined.