Aim: Evaluation and comparison of single dose of rectal Indomethacin, Diclofenac or Naproxen in prevention of post ERCP pancreatitis
Inclusion Criteria: During 1 year, all patients who undergo ERCP by taking consent inform will be enrolled in this study.
Exclusion criteria: patients who will undergo a prior endoscopic sphincterotomy.
Studied Patients: In a double-blind controlled randomized trial, patients will receive a suppository containing 100 mg of indomethacin or diclofenac 100 mg or Naproxen 500 mg just before doing ERCP.
Primary outcomes: Serum lipase and amylase levels will be measured in all patients after ERCP after 12 hours. Also clinical parameters will be evaluated including abdominal pain and number of admitted days in the ward and pancreatitis will be scored.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014100111192N3
Registration date:2014-11-08, 1393/08/17
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-11-08, 1393/08/17
Registrant information
Name
Mohammad Abbasinazari
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8887 3704
Email address
m_abbasi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2015-01-01, 1393/10/11
Expected recruitment end date
2016-01-01, 1394/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of rectal Indomethacin, Diclofenac or Naproxen on prevention of post Endoscopic cholangiopancreatography pancreatitis
Public title
Effect of indomethacin,diclofenac or naproxen on prevention of pancreatitis
Purpose
Prevention
Inclusion/Exclusion criteria
Patients undergoing ERCP in Taleghani hospital by taking written consent
Age
From 18 years old to 70 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
180
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee, Deputy of Reserch, School of Pharmacy, Shahid Beheshti University of Medical Scien
Street address
School of Pharmacy, Nyayesh junction, Valiasr street
City
Tehran
Postal code
Approval date
2014-09-02, 1393/06/11
Ethics committee reference number
23546
Health conditions studied
1
Description of health condition studied
pancreatitis
ICD-10 code
K85.8
ICD-10 code description
Other acute pancreatitis
Primary outcomes
1
Description
pancreatitis
Timepoint
10 days after doing ERCP
Method of measurement
clinical evaluation
Secondary outcomes
1
Description
gastrointestinal bleeding
Timepoint
10 days after doing ERCP
Method of measurement
clinical evaluation
2
Description
Hypersensitivity reactions
Timepoint
10 days after doing ERCP
Method of measurement
Clinical observation
Intervention groups
1
Description
Group1: Adminstration of single dose of 100 mg rectal indomethacine just before doing Endoscopic cholangiopancreatography
Group2: Administration of single dose of 100 mg rectal diclofenac just before doing Endoscopic cholangiopancreatography
Group 3: Administration of single dose of 500 mg rectal naproxen just before doing Endoscopic cholangiopancreatography
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
School of pharmacy, Shahid Behesti University of Medical Sciences
Full name of responsible person
Mohammad Abbasinazari
Street address
School of Pharmacy, Nyayesh junction, Valiasr street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research, School of Pharmacy, Shahid Beheshti Universty of Medical Sciences
Full name of responsible person
Nima Naderi
Street address
School of Pharmacy, Nyayesh junction, Valiasr street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research, School of Pharmacy, Shahid Beheshti Universty 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
School of pharmacy, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Abbasinazari
Position
PhD in Clinical pharmacy
Other areas of specialty/work
Street address
School of PharmacyNyayesh junction,Valiasr street
City
Tehran
Postal code
Phone
+98 21 8887 3704
Fax
Email
m_abbasi@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of pharmacy, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Abbasinazari
Position
PhD in Clinical Pharmacy
Other areas of specialty/work
Street address
School of Pharmacy, Nyayesh junction, Valiasr street
City
Tehran
Postal code
Phone
+98 21 8887 3704
Fax
Email
m_abbasi@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Pharmacy Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Abbasinazari
Position
PhD in Clinical Pharmacy
Other areas of specialty/work
Street address
School of Pharmacy, Nyayesh junction, Valiasr street
City
Tehran
Postal code
Phone
+98 21 8887 3704
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)