Prophylactic effect of rectal indomethacin administration, with and without intravenous hydration, on the development of pancreatitis after retrograde cholangiopancreatography
Overall, 406 patients who have fulfilled the criteria for undergoing endoscopic retrograde cholangiopancreatography (ERCP) and who have fulfilled the inclusion and exclusion criteria have been enrolled in this randomized single blind clinical trial. The patients have been allocated into an intervention and a placebo group. Initially, every patient is given a number from 1 to 4 by an internist and then referred to a gastroenterologist at Ghaem Hospital to undergo ERCP. Those with numbers 1, 2 and 3 are given 100 mg indomethacin per rectum, intravenous normal saline, and both indomethacin and normal saline, respectively, two hours prior to the endoscopic procedure. Patients with the number 4 are consider as the control group and receive glycerin per rectum. Blood samples are taken from patients with abdominal pain and vomiting 2, 12 and 24 hours post-ERCP for hyper-amylasemia. The diagnosis of post-endoscopic pancreatitis (PEP) is confirm with serum amylase levels 3 times the upper limit of normal. Subsequently, the prevalence of pancreatitis will be evaluated in every group based on clinical and laboratory findings. Finally, the results will be recorded and analyzed using statistical tests.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014082418915N1
Registration date:2014-10-24, 1393/08/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-10-24, 1393/08/02
Registrant information
Name
Mousalreza Hosseini
Name of organization / entity
Mashhad University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 80 1274 2513
Email address
hoseinimr@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University Of Medical Sciences
Expected recruitment start date
2013-05-12, 1392/02/22
Expected recruitment end date
2014-11-21, 1393/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Prophylactic effect of rectal indomethacin administration, with and without intravenous hydration, on the development of pancreatitis after retrograde cholangiopancreatography
Public title
Effect of rectal indomethacin and intravenous hydration in the prevention of pancreatitis after endoscopic retrograde cholangiopancreatography (single blind clinical
trial)
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Age>18y; Patients are eligible if they are diagnosed with choledocolithiasis. Exclusion criteria: Patients with previous unsuccessful sphincterotomy; Decreased state of consciousness; Cardiovascular, renal diseases and under dialysis patients; Increased risk of bleeding; Evident acute pancreatitis, chronic pancreatitis or pancreatic cancer; Hyperamylasemia (≥ 150 IU/L); Allergy or hypersensitivity to indomethacin or water-soluble contrast solutions; Having ingested NSAIDs a week earlier are enrol
Age
From 16 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
406
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashad University Of Medical Sciences
Street address
Goreyshi Building, Daneshgah Street, Mashad University Of Medical Sciences
City
Mashhad
Postal code
00985138412081
Approval date
2013-05-11, 1392/02/21
Ethics committee reference number
911008
Health conditions studied
1
Description of health condition studied
Calculus of bile duct without cholangitis or cholecystitis
ICD-10 code
K80.5
ICD-10 code description
Choledocholithiasis
Primary outcomes
1
Description
Frequency of post endoscopic retrograde cholangiopancreatography pancreatitis
Timepoint
2,12,24 hours post endoscopic retrograde cholangiopancreatography.
Method of measurement
Clinical exam and serum amylase measurement
Secondary outcomes
empty
Intervention groups
1
Description
Placebo: Patients in the control group only receive rectal glycerin.
Category
Treatment - Drugs
2
Description
Intervention: Patients divide up into three study groups and receive the intervention 2 hours prior to the procedure. The patients in the first group receive 100 mg of rectal indomethacin.
Category
Treatment - Drugs
3
Description
The patients in the second group receive intravenous normal saline perfusion.
Category
Treatment - Drugs
4
Description
The patients in the third group receive both interventions.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Mousalreza Hosseini
Street address
Internal Department, Ghaem Hospital, Ahmadabad Street
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Ghoreishi Biulding, Danseshgah Street, Research Vice Chanecellary, Mashhad University of Medical Sciences
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?