The aim of this clinical trial was evaluation effect of intravenous hydrocortisone on hyperamylasemia of patients underwent Endoscopic retrograde cholangiopancreatography (ERCP). Inclusion criteria included highness of amylase levels (less than three times normal) before ERCP. Exclusion criteria included current or history of corticosteroid use within 2 weeks ago, developing pancreatitis during the 2 weeks before ERCP and developing chronic pancreatitis. This study that performed on patients underwent ERCP. 90 patients evaluated in two case and control groups, in case group, Ampoule hydrocortisone (manufactured by pharmaceutical Exir) 100 mg will inject intravenously slowly at 0.5-1 hours before ERCP. In control group, 2 cc Normal saline (Placebo) will injected at 0.5-1 hours before ERCP. Amylase levels of patients will be checked at 2 hours after ERCP.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201410236388N6
Registration date:2014-12-19, 1393/09/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-12-19, 1393/09/28
Registrant information
Name
Mohamadhossein Somi
Name of organization / entity
Tabriz University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 41 1336 7499
Email address
somimh@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor of Tabriz University of Medical Sciences
Expected recruitment start date
2013-12-22, 1392/10/01
Expected recruitment end date
2014-11-22, 1393/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation effect of intravenous Hydrocortisone on hyperamylasemia of patients underwent Endoscopic retrograde cholangiopancreatography
Public title
Evaluation effect of Hydrocortisone on amylase level of patients underwent Endoscopic retrograde cholangiopancreatography
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:Highness of Amylase levels (less than three times normal) before ERCP.
Exclusion criteria: Developing diabetes; Current or history of corticosteroid use within 2 weeks ago; Developing pancreatitis during the 2 weeks before ERCP; Developing chronic pancreatitis
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Medical Faculty, Tabriz University of Medical Sciences, Daneshghah Ave, Tabriz
City
Tabriz
Postal code
Approval date
2010-04-28, 1389/02/08
Ethics committee reference number
9318
Health conditions studied
1
Description of health condition studied
Acute pancreatitis
ICD-10 code
K85.9
ICD-10 code description
Disease of pancreas, unspecified
Primary outcomes
1
Description
Serum Amylase
Timepoint
2 hours after ERCP
Method of measurement
Check by Laboratory
Secondary outcomes
empty
Intervention groups
1
Description
Case Group:
injection Ampoule hydrocortisone (manufactured by pharmaceutical Exir) 100 mg intravenously at 0.5-1 hours before ERCP
Category
Treatment - Drugs
2
Description
Control Group:
Injection of 2 cc Normal saline (Placebo) at 0.5-1 hours before ERCP
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Imam Reza Hospita
Full name of responsible person
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor of Tabriz University of Medical Sciences
Full name of responsible person
Mrs. Azari
Street address
Tabriz University of Medical Sciences
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor of Tabriz University of Medical Sciences
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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Amin Sadrazar
Position
Resident of Internal Medicine
Other areas of specialty/work
Street address
Tabriz Imam Reza Hospital
City
Tabriz
Postal code
Phone
+98 41 3337 3966
Fax
Email
a_sadrazar@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Amin Sadrazar
Position
Resident of Internal Medicine
Other areas of specialty/work
Street address
Tabriz Imam Reza Hospital
City
Tabriz
Postal code
Phone
+98 41 3337 3966
Fax
Email
a_sadrazar@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Amin Sadrazar
Position
Resident of Internal Medicine
Other areas of specialty/work
Street address
Tabriz Imam Reza Hospital
City
Tabriz
Postal code
Phone
+98 41 3337 3966
Fax
Email
a_sadrazar@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)