Evaluation of the effect of injectable somatostatin with indomethacin on the incidence of pancreatitis after endoscopic retrograde cholangiography compared with indomethacin and placebo
Design
In this clinical trial, all patients with diagnosis of bile duct disorders who referred to perform ERCP method in 5 Azar hospital. Comparison between two study groups will be done in terms of age and sex of the patient and the reason for performing ERCP. Necessary ethical licenses will be obtained from the ethics committee of Golestan University of Medical Sciences. A written informed consent will be obtained from all. Patients will then be randomly divided into two groups: 1) injectable somatostatin and indomethacin, and 2) indomethacin and placebo. Serum amylase levels are considered to be more than 3 times normal as hyper-amylase.
Settings and conduct
This study will be performed as a randomized, triple-blind, clinical trial in Gorgan's 5 Azar Hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with biliary tract disorders refer to Gorgan 5 Azar Hospital to perform ERCP from the beginning of March 2018.
Exclusion criteria: previuos sphincterotomy, history of chronic pancreatitis. Allergy to somatostatin or NSAIDS
Intervention groups
Group 1: somatostatin plus indomethacin
Group 2: Indomethacin plus placebo
Assessment the role of somatostatin and indomethacin versus only indomethacin in the incidence of post – ERCP pancreatitis
Public title
Role of somatostatin in the incidence of post – ERCP pancreatitis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with biliary tract problems who refer to 5 Azar Hospital in gorgan to perform ERCP diagnostic-therapeutic method from the beginning of April 2017.
Exclusion criteria:
Previous history of sphincterotomy
history of chronic pancreatitis
acute pancreatitis when visiting
Allergy to somatostatin or NSAIDS
Age
From 18 years old to 95 years old
Gender
Both
Phase
4
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
360
Actual sample size reached:
376
Randomization (investigator's opinion)
Randomized
Randomization description
In this way, using the Block Balanced Randomization method with four blocks and preparing a list of blocks and assigning numbers to them, a list of treatment allocations is prepared and patients are assigned to one of the somatostatin and indomethacin groups or indomethacin group according to the list
Blinding (investigator's opinion)
Triple blinded
Blinding description
Due to the use of numbers to randomly assign patients to treatment groups and the use of quadruple blocks, all patients are coded.
Patients in the intervention group and patients in the control and subspecialty group of gastroenterologists performing ERCP, the laboratory assessing the level of amylase, and the statistical consultant analyzing the data will be unaware of which group the patient belongs to. Evaluation and increase of accuracy and objectivity of clinical results were performed.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical committee of Golestan University of Medical Sciences
Street address
Shast kola
City
Gorgan
Province
Golestan
Postal code
4918936316
Approval date
2018-06-17, 1397/03/27
Ethics committee reference number
IR.GOUMS.REC.1397.042
Health conditions studied
1
Description of health condition studied
Pancreatitis
ICD-10 code
K85.9
ICD-10 code description
Acute pancreatitis, unspecified
Primary outcomes
1
Description
Pancreatitis
Timepoint
2 and 18 hours
Method of measurement
serum amylase
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: somatostatin plus indometacin. Somatostatin 250 μg bolus for 1-2 minutes pre-ERCP Long-term infusion of somatostatin 500μg, started during ERCP and lasted for two hours Indomethacin suppository 100mg pre-ERCP and 100mg post-ERCP
Category
Treatment - Drugs
2
Description
Control group: Indomethacin alone. For control group, normal saline and indomethacine suppository (100 mg) were administrated before and after ERCP.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
5 Azar hospital
Full name of responsible person
Alireza Norouzi
Street address
Shast kola
City
Gorgan
Province
Golestan
Postal code
4918936316
Phone
+98 17 3242 4103
Email
norouzi54@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
MohamadReza Honarvar
Street address
Shast kola
City
Gorgan
Province
Golestan
Postal code
4918936316
Phone
+98 17 3242 4103
Email
drmrhonarvar@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan 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
Gorgan University of Medical Sciences
Full name of responsible person
Alireza Norouzi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Shast kola
City
Gorgan
Province
Golestan
Postal code
4918936316
Phone
+98 17 3242 4103
Email
norouzi54@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Alireza Norouzi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Shast kola
City
Gorgan
Province
Golestan
Postal code
4918936316
Phone
+98 17 3242 4103
Email
norouzi54@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Alireza Norouzi
Position
MD, Gastroentrologist
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
GI department, Sayyad-e-Shirazi Hospital
City
Gorgan
Province
Golestan
Postal code
4918936316
Phone
+98 17 3234 0835
Fax
Email
norouzi54@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not 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 potential data can be shared after people have not been identified
When the data will become available and for how long
from December 2020
To whom data/document is available
all
Under which criteria data/document could be used
-
From where data/document is obtainable
To the PI of the study
What processes are involved for a request to access data/document