This is an intervention before-after study which investigates the effect of percutaneous biliary balloon dilatation in symptomatic patients suffering from benign biliary strictures. We include Patients in the study if there has been confirmed benign biliary stricture؛ clinical symptoms were present such as icterus, pruritus, in addition to increase in serum bilirubin and liver enzymes. Patients with the following criteria will exclude from the study: any history of malignancies؛ absence patient compliance.Our sample volume is calculated 24. After the confirmation of ethical consequences by ethics committee of the Imam Khomeini hospital; patients have been introduced to the details of the procedure and signed the informed consent forms. Patients asked to stop taking anticoagulant agents 5-7 days prior to scheduled procedure. Percutaneous transhepatic cholangiography will be done and external biliary drainage using a pigtail catheter for a week will insert. After one week, a 40-80 mm length angioplasty balloon using high pressure inflation (20 atmospheres) will insert for 15 minutes in a single session.
Follow up session will performed one week later using percutaneous transhepatic cholangiography. The dilatation session will repeat if remained stricture would be visible in percutaneous transhepatic cholangiography. Follow-ups in 3 and 6 months later will be done if the duct would be patent in percutaneous transhepatic cholangiography. Serum Bilirubin level, liver enzymes level and ultrasonography findings will investigate in every follow-up session.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201406247435N2
Registration date:2014-11-28, 1393/09/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-11-28, 1393/09/07
Registrant information
Name
Hazhir Saberi
Name of organization / entity
Diagnostic and interventionalradiology department
Country
Iran (Islamic Republic of)
Phone
+98 21 6658 1577
Email address
saberi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2012-11-01, 1391/08/11
Expected recruitment end date
2014-12-30, 1393/10/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of percutaneous ballooning in the treatment of benign biliary strictures
Public title
Evaluation of the effect of percutaneous ballooning in the treatment of benign biliary strictures
Tehran University of Medical Sciences Research Faculty
Street address
Tehran University of Medical Sciences
City
Tehran
Postal code
Approval date
2012-10-23, 1391/08/02
Ethics committee reference number
91-02-98-237-63-191
Health conditions studied
1
Description of health condition studied
benign billiary stricture
ICD-10 code
K83.1
ICD-10 code description
Obstruction of bile duct Occlusion Stenosis Stricture of bile duct without calculus
Primary outcomes
1
Description
Releaving of billiary stenosis
Timepoint
Before and after intervention
Method of measurement
Cholangiography
Secondary outcomes
1
Description
Cholestatic symptoms
Timepoint
Before and after and 6 month after intervention
Method of measurement
Interview
2
Description
Total billirubin
Timepoint
Before and after and 6 month after intervention
Method of measurement
Blood test
Intervention groups
1
Description
percutaneus balloon dilation
In this procedure ballon holded catheter inserts bile ducts percotaneously. when ballon placed in proper site of stricture, dilatation is done. This procedure is performed under chollangiography guide.
There is not control group in this study
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeni Hospital Imaging Center
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University 0f Medical Science
Full name of responsible person
Hazhir Saberi
Street address
Imam Khomeni Hospital Imaging Center
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University 0f Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Imam Khomeni Hospital Imaging Center
Full name of responsible person
Hazhir Saberi
Position
assistant professor
Other areas of specialty/work
Street address
Imam Khomeni Hospital Imaging Center
City
Tehran
Postal code
Phone
+98 912 101 1280
Fax
Email
saberi@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Imam Khomeni Hospital Imaging Center
Full name of responsible person
Hazhir Saberi
Position
Radiologist MD
Other areas of specialty/work
Street address
Imam Khomeni Hospital Imaging Center
City
Tehran
Postal code
Phone
+98 912 101 1280
Fax
Email
saberi@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Somaye Karimi
Position
assistant of Radiology
Other areas of specialty/work
Street address
]Imam Khomeini Hospital
City
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)