Comparing the effect of single dose of rectal Indomethacin plus vitamin C injection versus single dose of rectal indomethacin on prevention of post ERCP pancreatitis
Design
Two arm parallel group randomised trial with blinded postoperative care and outcome assessment
Settings and conduct
setting: Endoscopy ward of Talighani hospital, Tehran,Iran
Participants/Inclusion and exclusion criteria
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.
Intervention groups
Group1: Adminstration of single dose of 100 mg rectal indomethacine plus injection of 500 mg vitamin C just before doing Endoscopic cholangiopancreatography Group2: Administration of single dose of 100 mg rectal indomethacin just before doing Endoscopic cholangiopancreatography
Main outcome variables
pancreatitis occurence
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20121021011192N11
Registration date:2021-04-04, 1400/01/15
Registration timing:prospective
Last update:2021-04-04, 1400/01/15
Update count:0
Registration date
2021-04-04, 1400/01/15
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
Expected recruitment start date
2021-05-21, 1400/02/31
Expected recruitment end date
2022-05-21, 1401/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of indomethacin suppository plus vitamin C injection verusus indomethacin suppository in prevention of post ERCP pancreatitis
Public title
Comparing the rectal Indomethacin plus vitamin C injection versus rectal indomethacin on prevention of post ERCP pancreatitis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing ERCP in Taleghani hospital by taking written consent
Exclusion criteria:
Patients history of hypersensitivity against each of indomethacin or vitamin C
Active peptic ulcer diseases
Renal impairment (GFR < 10 ml/min)
Age
No age limit
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
280
Randomization (investigator's opinion)
Randomized
Randomization description
simple, block, individual, using table of random numbers.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of pharmacy, nursing and midwifery of Shahid Beheshti university of medical science
Street address
School of Pharmacy, Nyayesh junction, Valiasr street
City
Tehran
Province
Tehran
Postal code
1996835113
Approval date
2021-03-13, 1399/12/23
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1399.375
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 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 Indomethacine plus 500 mg vitamin C injection 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
Province
Tehran
Postal code
1996835113
Phone
+98 21 8887 3704
Email
m_abbasi@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Hassan Yazdanpanah
Street address
School of Pharmacy, Nyayesh junction, Valiasr street
City
Tehran
Province
Tehran
Postal code
1996835113
Phone
+98 21 8866 5282
Email
yazdanpanah@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Abbasinazari
Position
full professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
School of PharmacyNyayesh junction,Valiasr street
City
Tehran
Province
Tehran
Postal code
1996835113
Phone
+98 21 8887 3704
Email
m_abbasi@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Abbasinazari
Position
full professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Nyayesh junction, Valiasr street
City
tehran
Province
Tehran
Postal code
1996835113
Phone
+98 21 8887 3704
Email
m_abbasi@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Abbasinazari
Position
full professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Nyayesh junction, Valiasr street
City
Tehran
Province
Tehran
Postal code
1996835113
Phone
009888873704
Email
ｍ_abbasi@sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared after deidentified
When the data will become available and for how long
starting in ِDecember 2021
To whom data/document is available
only available for people working in academic institutions
Under which criteria data/document could be used
with written consent
From where data/document is obtainable
Sending email to: m_abbasi@sbmu.ac.ir
What processes are involved for a request to access data/document