Evaluation of the effect of sublingual isosorbide dinitrate + indomethacin suppository in prevention of post Endoscopic retrograde colangiopancreatography (ERCP) pancreatitis
Aim of the study: Panceatitis is the most common complication after Endoscopic retrograde colangiopancreatography (ERCP) procedure and usually ends to long hospitalization .In severe cases it ends to complications that needs to surgical intervention and sometimes it causes death. It seems that sublingual isosorbide is effective for prevention of post ERCP pancreatitis. In this study we want to assess the influence of sublingual isosorbide with indomethacin suppository in prevention of post ercp pancreatitis. Study population: study population, are pancreatobilliary patients that must undergo ercp so they are introduced to endoscopy ward of shariati hospital that includes a population of 300 people who have the inclusion criteria of this study. All people who refer to ERCP ward of Shariati hospital will be included in our study if they have inclusion criteria of our study. Understudy intervention and primary outcomes: if they have inclusion criteria of our study, number one form will be filled with a general physician. 5 minutes before ercp procedure the case group take one pill of sublingual isosorbide and the control group will take placebo. All the patients will take indomethacin 100 mg, 5 minutes before the procedure. Serum amylase is measured 2 and 24 hours after ercp and patients will be assessed for pancreatitis signs and drug side effects and data will be registered in number 2 form. After each 3 months until the end of the study patient codes will be opened and sectional analysis will be evaluated and final results will be presented at the end of the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138810082931N1
Registration date:2012-11-19, 1391/08/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-11-19, 1391/08/29
Registrant information
Name
Rasoul Sotoudehmanesh
Name of organization / entity
Digestive Disease Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 8241 5225
Email address
setoodeh@ams.ac.ir
Recruitment status
Recruitment complete
Funding source
Digestive Disease Research center
Expected recruitment start date
2011-02-20, 1389/12/01
Expected recruitment end date
2014-02-20, 1392/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of sublingual isosorbide dinitrate + indomethacin suppository in prevention of post Endoscopic retrograde colangiopancreatography (ERCP) pancreatitis
Public title
Assessment of the effect of sublingual isosorbide dinitrate with indomethacin suppository on post Endoscopic retrograde colangiopancreatography pancreatitis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Study populations are all patients referred to Shariati hospital who undergo therapeutic or diagnostic ERCP in endoscopy ward.
Exclusion criteria: age<18; HX of nitrate use; HX of recent acute pancreatitis (less than one month); HX of chronic pancreatitis; recent (2weeks) peptic ulcer bleeding; HX of glaucoma; ampullary tumor; use of sildenafil; unwilling for consent; allergy to drugs; previous sphincterotomy.
Age
From 18 years old to 100 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
300
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
Digestive Disese Research Center
Street address
Shariati hospital, North Kargar
City
Tehran
Postal code
Approval date
2011-08-20, 1390/05/29
Ethics committee reference number
416/548
Health conditions studied
1
Description of health condition studied
pancreatitis
ICD-10 code
K85.0
ICD-10 code description
Idiopathic acute pancreatitis
Primary outcomes
1
Description
post ercp pancratitis
Timepoint
24 hours after ercp
Method of measurement
pain observative scale, serum amylase measurement, hospitalation period
Secondary outcomes
1
Description
nausea and vomiting
Timepoint
24 hours after procedure
Method of measurement
asking from patient
2
Description
fever/chills
Timepoint
2 and 24 hours after procedure
Method of measurement
check of fever grade with termometer
3
Description
upper GI bleeding
Timepoint
2 and 24 hours after procedure
Method of measurement
check of vital sighns, hematemesis and melena
Intervention groups
1
Description
indomethacin 100 mg anal with sublingual tablet of isosorbide dinitrate 5 mg
Category
Treatment - Drugs
2
Description
indomethacin 100 mg anal with sublingual placebo of isosorbide dinitrate 5 mg
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Digestive Disease Research Center
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Digestive disease research center
Full name of responsible person
Rasoul Sotoudehmanesh
Street address
Shariati hospital, At the end of kargar street, postal code 14117-13135
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Digestive disease research center
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
Digestive Disease Research Center
Full name of responsible person
Maryam Farsinejad
Position
Research Fellow.MD
Other areas of specialty/work
Street address
Digestive Disease Research Center, Shariati Hospital
City
Tehran
Postal code
Phone
+98 21 8241 5770
Fax
Email
maryfnm@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Digrstive Disease Research Center
Full name of responsible person
Rasoul Sotoudehmanesh
Position
fellowship of gasteroenterology
Other areas of specialty/work
Street address
Shariati Hospital, North kargar
City
Tehran
Postal code
Phone
+98 21 8241 5225
Fax
Email
setoodeh@ams.ac.ir , r.sotoudehmanesh@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Maryam Farsinejad
Position
Other areas of specialty/work
Street address
City
Postal code
14114
Phone
+98 21 8241 5704
Fax
Email
maryfnm@yahoo.com
Web page address
www.ddri.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)