Efficacy of suppository naproxen in preventation of post ERCP pancreatitis in patients referred to RAZI hospital in RASHT , the study population is all patients who were referred for ERCP to Razi hospital. Inclusion criteria:All patients over 18 years who were referred to hospital for ERCP or disorders in liver function tests or had extrahepatic cholestasis.Exclusion criteria: Acute pancreatitis in the last two weeks or history of chronic pancreatitis and a history of previous sphincterotomy and NSAID use in a week and contraindication for NSAID use , peptic ulcer with recent GI bleeding and not consent to participate in this plan. During the study people with inclusion criteria assign randomly to two groups.Case group take suppository naproxen (500 miligram) just before surgery and control group take placebo.The main consequence of study is pancreatitis. All patients are monitored of pancreatitis till 24 hours.Patients with abdominal pain and scores more than 3 times the enzyme amylase in 24 hours after surgery are considered pancreatitis. Serum amylaze is checked 2 hours after ERCP, if there is no clinical pancreatitis , the patient will start to eat normally but if it be more than 3 times of normal and the patient have abdominal pain ,nausea and vomiting, he/she will be NPO and prescribed intravenous fluids and narcotic for its pain. َAfter 24 hours, amylase will be checked, patient be examined again and pancreatitis is confirmed with back and epigastric pain.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201105301155N14
Registration date:2013-02-10, 1391/11/22
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-02-10, 1391/11/22
Registrant information
Name
Farahnaz Joukar
Name of organization / entity
Guilan University of Medical Sciences, Gastrointestinal and liver disease Research Center
Country
Iran (Islamic Republic of)
Phone
+98 13 1553 5116
Email address
info@gldrc.org
Recruitment status
Recruitment complete
Funding source
Vince chancellor for reaserch Guilan University of Medical Sciences
Expected recruitment start date
2013-02-15, 1391/11/27
Expected recruitment end date
2014-09-15, 1393/06/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of suppository naproxen in preventation of post ERCP pancreatitis in patients referred to RAZI hospital in RASHT
Public title
Efficacy of suppository naproxen in prevention of pancreatitis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: All patients over 18 years who were referred to hospital for ERCP; disorders in liver function tests; had extrahepatic cholestasis.
Exclusion criteria: Acute pancreatitis in the last two weeks; history of chronic pancreatitis; a history of previous sphincterotomy; NSAID use in a week; contraindication for NSAID use such as renal failure and having allergy to the drug; peptic ulcer with recent GI bleeding; not consent to participate in this plan.
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
324
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
Guilan University of Medical Sciences. Ethics Committee Gastrointestinal and Liver Diseases Research
Street address
Sardar jangle Ave-Razi hospital-Gastrointestinal and liver disease research center.
City
Rasht
Postal code
41448-95655
Approval date
2011-05-26, 1390/03/05
Ethics committee reference number
160/1/ش
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
24 hours after ERCP
Method of measurement
Amylase serum, Patient's symptoms(nausea, vomiting and abdominal pain)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group take naproxen supp. 500 miligram just before ERCP.
Category
Prevention
2
Description
Control group take placebo suppository.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Gastrointestinal clinic of Razi hospital
Full name of responsible person
Farahnaz Joukar
Street address
Gastrointestinal and Liver Diseases Research Center, Razi Hospita, Sardare Jangal Avenue
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Behvazan Company
Full name of responsible person
Dr. Seyed Mohamad Keshavarz
Street address
Rasht industrialcity Behvazan Company
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Behvazan Company
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
Gastrointestinal and Liver Disease Research Center(GLDRC)
Full name of responsible person
Farahnaz Joukar
Position
assistant of gastrointestinal and liver disease research center (GLDRC)
Other areas of specialty/work
Street address
Gastrointestinal and Liver Disease Research Center (GLDRC) , Razi hospital , Sardar Jangal Ave.
City
Rasht
Postal code
Phone
+98 13 1553 5116
Fax
Email
F_Jokar@gums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gastrointestinal and Liver Disease Research Center (GLDRC)
Full name of responsible person
Dr.Fariborz Mansour-Ghanaei
Position
Head / Full Professor of Internal Medicine & Gastroenterology
Other areas of specialty/work
Street address
Gastrointestinal and Liver Disease Research Center (GLDRC) , Razi hospital , Sardar Jangal Ave.
City
Rasht
Postal code
Phone
+98 13 1553 5116
Fax
Email
ghanaei@gums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Gastrointestinal and liver disease research center
Full name of responsible person
Dr. Maryam Bakhshandeh
Position
Researcher/General Physician
Other areas of specialty/work
Street address
Gastrointestinal and Liver Disease Research Center (GLDRC) , Razi hospital , Sardar Jangal Ave.
City
Rasht
Postal code
Phone
+98 13 1553 5116
Fax
Email
bmaryamb@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)