Acute pancreatitis is the most common and most feared complication during Endoscopic retrograde cholangiopancreatography (ERCP) and it has high prevalance of mortality and morbidity rarely. one risk factor for this complication is canulation in pancreatobilliary duct during ERCP. Observed that the use of medications such as nonsteroidal anti-inflammatory drugs may prevent this complication. This study is a placebo-controlled clinical trial with simple sampling. Persons between 15 to 55 years without advanced systemic disease and were not drug addicts or continuous drug use and with mild hepatobilliary disease without fibrosis or cirrhosis are enrolled. If patient has no desire to continue study or in other complications after ERCP are excluded. Two groups of 38 patients enrolled in the drug group that use Celecoxib capsule 3 capsule 100mg and the placebo group that use 3 capsule 100mg placebo capsule manufacturing pharmaceutical Sajad, 5 hours before the intervention. serum amylase level is measured at capsule use time and 2 hours after intervention and patient is evaluate about pancreatitis signs and symptoms until 2 hours after intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201207252417N8
Registration date:2012-08-06, 1391/05/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-08-06, 1391/05/16
Registrant information
Name
Firouzeh Moeinzadeh
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1625 5555
Email address
moinzade@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Isfahan University of Medical Sciences
Expected recruitment start date
2012-04-20, 1391/02/01
Expected recruitment end date
2012-08-21, 1391/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Celecoxib in the prevention of pancreatitis after Endoscopic retrograde cholangiopancreatography (ERCP)
Public title
Effect of Celecoxib in the prevention of pancreatitis after Endoscopic retrograde cholangiopancreatography (ERCP)
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
1- no advanced systemic disease
2- no addiction
3- no continouse drug use
4- mild hepatobilliary disease with liver enzyme elevation to 4 times of normal upper limit.
5- without fibrosis, cirrhosis or infectious hepatitis
exclusion criteria:
1- other side effects except pancreatitis after ERCP
2- Lack of consent to cooperate in trial.
Age
From 15 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice Chancellor for Research, Isfahan University of Medical Sciences
Street address
Hezar Jarib street
City
Isfahan
Postal code
Approval date
2011-11-09, 1390/08/18
Ethics committee reference number
390375
Health conditions studied
1
Description of health condition studied
Acute Pancreatitis
ICD-10 code
K85.8
ICD-10 code description
Other acute pancreatitis
Primary outcomes
1
Description
Pancreatitis
Timepoint
Befor and 2 hours after Endoscopic retrograde cholangiopancreatography
Method of measurement
Pain and clinical signs
2
Description
Serum amylase level
Timepoint
Befor and 2 hours after Endoscopic retrograde cholangiopancreatography
Method of measurement
ELISA kits: International Unit per Littre
Secondary outcomes
empty
Intervention groups
1
Description
Cap celecoxib 100mg, 3 capsuls. Sajjad Pharmaceutical Company, Mashad. 5 hours before Endoscopic retrograde cholangiopancreatography
Category
Treatment - Drugs
2
Description
Cap Placebo, 3 capsuls. Sajjad Pharmaceutical Company, Mashad. 5 hours before Endoscopic retrograde cholangiopancreatography
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital, Endoscopy Department
Full name of responsible person
Dr. Zhaleh Derakhshan
Street address
Alzahra Hospital
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Isfahan University of Medical Sciences
Full name of responsible person
Dr. Peyman Adibi
Street address
Hezar Jarib Street.Isfahan University of Medical Sciences
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Isfahan 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
Isfahan University of Medical Science
Full name of responsible person
Dr zhaleh derakhshan
Position
Internal Medicine Resident
Other areas of specialty/work
Street address
Alzahra hospital
City
Isfahan
Postal code
Phone
+98 31 1668 5555
Fax
Email
mona.derakhshan@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Science
Full name of responsible person
Dr Mohammad Minakari
Position
Associate Professor of Gastroentrology
Other areas of specialty/work
Street address
Alzahra hospital, Gastroentrology ward.
City
Isfahan
Postal code
Phone
+98 31 1628 5555
Fax
Email
minakari@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Firouzeh Moeinzadeh
Position
Internist
Other areas of specialty/work
Street address
Alzahra Hospital
City
Isfahan
Postal code
Phone
+98 31 1668 5555
Fax
Email
moinzade@resident.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)