Objectives: This study was scheduled with the aim of the effect of three methods of Rectal Naproxen Suppository,Isosorbide Dinitrate tablets and concurrent use of Rectal Naproxen Suppository with Isosorbide Dinitrate tablets in the prevention of Post-ERCP (Endoscopic Retrograde Cholangiopancreatogram) Pancreatitis in patients referred to Razi Hospital. Design: In this double-blind clinical trial (phase 3) with a sample size of 585, patients are randomized into three intervention groups. Also, they are examined in order to pancreatitis. Setting and conduct: due to sedation before ERCP, Lidocaine oral spray and Midazolam injection 0.05 mg/kg are applied. If Midazolam is contraindicated, Pethidine injection 1 mg/kg will be used. Therefore, the intervention will be performed. At the end of the ERCP the followings are registered: age, gender, and the details of procedure including: the total required time for the bile duct cannulation, final diagnosis, Implementations of sphincterotomy, injected contrast agent into the pancreatic duct and the presence or absence of Juxtapapillary diverticulum are stated. All the patients are considered in terms of acute pancreatitis up to 24 hours. Exclusion criteria: Acute pancreatitis in the last 2 weeks and history of chronic pancreatitis. Intervention: Intervention group 1: The group that received 500 milligram Rectal Naproxen Suppository once immediately before ERCP (Manufacturing factory is Behvazan); Intervention group 2: Isosorbide Dinitrate tablets 5 milligram once immediately before ERCP( Manufacturing factory is UCB Pharma GmbH); Intervention group 3: Concurrent use of naproxen suppository 500 milligram and Isosorbide Dinitrate tablets 5 milligram once immediately before ERCP.Main outcome measures: serum levels of amylase 2 and 24 hours after ERCP.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201409251155N22
Registration date:2015-10-14, 1394/07/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-10-14, 1394/07/22
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
Vice chancellor for research of Guilan University of Medical Sciences
Expected recruitment start date
2015-06-07, 1394/03/17
Expected recruitment end date
2016-02-22, 1394/12/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of three methods of Naproxen ,Isosorbide Dinitrate and concurrent use of them in prevention of Post- ERCP Pancreatitis
Public title
Comparison of effect of three methods of Rectal Naproxen Suppository, Isosorbide Dinitrate tablets and concurrent use of Rectal Naproxen Suppository with Isosorbide Dinitrate tablets in Prevention of Post- Endoscopic Retrograde Cholangio Pancreatography (ERCP) pancreatitis in patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: All patients over 18 years who were referred to Razi Hospital of Rasht for ERCP. Exclusion criteria: Acute pancreatitis in the last two weeks; history of chronic pancreatitis; a history of previous sphincterotomy; NSAID or Nitrate usage in a week prior and contraindication for NSAID or Nitrate usage like renal failure; recent Peptic Ulcer disease with recent GI Bleeding; Hypotension and Hypersensitivity to recent Each of the two drugs and lack of satisfaction of participate in this study.
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
585
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Gastrointestinal and Liver Disease Research Center of Guilan University of Medic
Street address
Namjoo Street
City
Rasht
Postal code
Approval date
2014-07-14, 1393/04/23
Ethics committee reference number
1930175708
Health conditions studied
1
Description of health condition studied
Post ERCP Pancreatitis
ICD-10 code
k85.8
ICD-10 code description
Other Acute Pancreatitis
Primary outcomes
1
Description
serum levels of Amylase
Timepoint
Two hours after ERCP
Method of measurement
Laboratory Kit
2
Description
symptoms of nausea, vomiting and abdominal pain
Timepoint
2 hours after ERCP
Method of measurement
Observations with check list
Secondary outcomes
1
Description
serum levels of Amylase
Timepoint
24 hours after ERCP
Method of measurement
Laboratory Kit
2
Description
symptoms of nausea, vomiting and abdominal pain
Timepoint
24 hours after ERCP
Method of measurement
Observation with check list
Intervention groups
1
Description
Intervention group 1: Rectal Naproxen Suppository, 500 milligram, once immediately before ERCP, Manufacturing factory is Behvazan
Category
Prevention
2
Description
Intervention group 2: Isosorbide Dinitrate tablets, 5 milligram, once immediately before ERCP,Manufacturing factory is UCB Pharma GmbH
Category
Treatment - Drugs
3
Description
Intervention group 3: Concurrent use of naproxen suppository 500 milligram and Isosorbide Dinitrate tablets 5 milligram once immediately before ERCP
Category
Treatment - Drugs
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 Hospital, Sardare Jangal Avenue, Guilan province, IRAN
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Guilan University of Medical Sciences
Full name of responsible person
Dr.Rasool Tabari KHomeirani
Street address
Sadati st, Namjoo st, Rasht, Guilan
City
Rasht
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 of Guilan University of Medical Sciences
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Behvazan Company
Full name of responsible person
Dr. seyed Mohamad Keshavarz
Street address
Behvazan Company,Rasht industrialcirty
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
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, Guilan province, IRAN
City
Rasht
Postal code
41448-95655
Phone
+98 13 3353 5116
Fax
Email
F_Jokar@gums.ac.ir
Web page address
www.gldrc.org
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
Professor of Gastroenterology and Hematology Guilan, Chief of Gastrointestinal and Liver Disease Res
Other areas of specialty/work
Street address
Gastrointestinal and Liver Disease Research Center (GLDRC), Razi Hospital, Sardar Jangal Ave, Guilan province, IRAN
City
Rasht
Postal code
Phone
+98 13 1553 5116
Fax
Email
ghanaei@gums.ac.ir
Web page address
www.gldrc.org
Person responsible for updating data
Contact
Name of organization / entity
Gastrointestinal and Liver Disease Research Center
Full name of responsible person
Sara Mavaddati
Position
Bachelor of Cellular & Molecular Biology
Other areas of specialty/work
Street address
Gastrointestinal and Liver Disease Research Center (GLDRC), Razi Hospital, Sardar Jangal Ave, Guilan province, IRAN
City
Rasht
Postal code
Phone
00
Fax
Email
mavaddati.sara@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)