Effect of Rectal Indomethacin and Nitroglycerin in Comparison with Rectal Indomethacin in the Prevention of post Endoscopic Retrograde Cholangio Pancreatography (ERCP) Pancreatitis
Impact of coadministration of rectal Indomethacin and Sublingual Nitrates in prevention of post ERCP pancreatitis
Design
In this research, 324 eligible patients needed ERCP referring to Qom gastroenterology clinic were chosen purposefully. Then, patients by block randomization were randomly divided into two control and intervention groups.
Settings and conduct
The study was performed as a randomized clinical trial at Shahid Beheshti Hospital in Qom. The study is double-blinded, and intervention is conducted by someone other than the care provider, and care provider and participants is unaware of the type of treatment.
Participants/Inclusion and exclusion criteria
People entering the study aged 18 to 70 years and patients who have contraindication for taking Indomethacin or Nitroglycerin were not included in the study.
Intervention groups
Intervention group: Indomethacin suppository, 100 mg, single dose, before ERCP plus nitroglycerin tablet, 0.4 mg, single sublingual, immediately after ERCP. Control group: Indomethacin suppository, 100 mg, single dose, before ERCP plus placebo tablet, single dose, sublingual, immediately after ERCP
Main outcome variables
Post ERCP pancreatitis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161205031252N5
Registration date:2018-01-18, 1396/10/28
Registration timing:retrospective
Last update:2018-01-18, 1396/10/28
Update count:0
Registration date
2018-01-18, 1396/10/28
Registrant information
Name
Ahmad Hormati
Name of organization / entity
Qom university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 25 3612 2053
Email address
hormatia@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-06-25, 1395/04/05
Expected recruitment end date
2016-09-22, 1395/07/01
Actual recruitment start date
2016-06-25, 1395/04/05
Actual recruitment end date
2016-09-22, 1395/07/01
Trial completion date
empty
Scientific title
Effect of Rectal Indomethacin and Nitroglycerin in Comparison with Rectal Indomethacin in the Prevention of post Endoscopic Retrograde Cholangio Pancreatography (ERCP) Pancreatitis
Public title
Rectal Indomethacin and Sublingual Nitrates in prevention of post ERCP pancreatitis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
aged 18-70
Need for ERCP
Exclusion criteria:
Contraindications of nitroglycerin
Contraindications of Indomethacin
Pregnancy
Lactation
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
324
Actual sample size reached:
324
Randomization (investigator's opinion)
Randomized
Randomization description
block randomization at the level of the individual
Blinding (investigator's opinion)
Double blinded
Blinding description
participants and the therapist does not know the allocation of people, and only the person who supplies the medication to the patients is aware of the type of allocation.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qom University of Medical Sciences
Street address
No. 83, 4th alley, 1.1 alley, Safashahr Blvd
City
Qom
Province
Ghoum
Postal code
3716987366
Approval date
2016-06-23, 1395/04/03
Ethics committee reference number
IR.MUQ.REC.1395.43
Health conditions studied
1
Description of health condition studied
ERCP-induced 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
Serum levels of pancreatic enzymes
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Indomethacin suppository, 100 mg, single dose, before ERCP plus nitroglycerin tablet, 0.4 mg, single sublingual, immediately after ERCP
Category
Treatment - Drugs
2
Description
Control group: Indomethacin suppository, 100 mg, single dose, before ERCP plus placebo tablet, single dose, sublingual, immediately after ERCP