Evaluation of epinephrine spray efficacy versus placebo in prevention of acute pancreatitis following ERCP
Design
A double-blinded randomized parellel clinical trial with a control group in phase 1 on 140 patients using random allocation table for the randomization
Settings and conduct
The study was conducted on all patients referred to ALzahra Hospital affiliated at Isfahan University of Medical Sciences until achieving the desired number of patients. Only the nurse responsible for injections during ERCP was aware of the remedies, and the physician, the patient, were unaware.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age above 18 years old, candidate for ERCP due to any reason and willingness for participation in the study
Unmet criteria: contraindication for treatment with epinephrine (hyperthyroidism, cardiac arrhythmia), uncontrolled ischemic cardiac disease, previous history of acute or chronic pancreatitis, previous history of pancreatic duct manipulation
Intervention groups
All patients underwent ERCP based on standard protocols.
The intervention group was treated with 20 ml epinephrine spray 0.02% (Darupakhsh Company; Iran) on the papilla for a minute and the control group was treated with normal saline spray similar in volume and duration of spraying.
Main outcome variables
Amylase and lipase level within 24 hours after ERCP
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201128049521N1
Registration date:2020-12-15, 1399/09/25
Registration timing:retrospective
Last update:2020-12-15, 1399/09/25
Update count:0
Registration date
2020-12-15, 1399/09/25
Registrant information
Name
Laleh Raeisi Bidakani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3444 7707
Email address
raesibidakanilaleh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
2018-09-23, 1397/07/01
Actual recruitment end date
2019-11-16, 1398/08/25
Trial completion date
2019-11-16, 1398/08/25
Scientific title
Assessment of epinephrine spray versus placebo for prevention from acute pancreatitis following endoscopic retrograde colangiopancreatography (ERCP)
Public title
Prevention of pancreatitis by epinephrine spray after endoscopic retrograde cholangiopancreatography
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Over 18 years old of age
Indication for ERCP due to any etiology
Willingness for participation in the study
Exclusion criteria:
Any contraindication for epinephrine administration (hyperthyroidism, cardiac arrhythmia)
Uncontrolled cardiac ischemic disease
Previous history of acute and chronic pancreatitis
Previous history of pancreatic duct manipulation
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
140
Actual sample size reached:
124
Randomization (investigator's opinion)
Randomized
Randomization description
The patients were gathered until achieving the desired number of the study population. Randomization was done through simple sampling, in individual units. Each of the patients was provided with a sealed envelope. Prior to the intervention, the envelope was unwrapped by the nurse and the desired intervention was done. The physician was blinded about the type of intervention.
Blinding (investigator's opinion)
Double blinded
Blinding description
The nurse responsible for injections during ERCP was the only person aware of the remedy, but the patient and the physician were not.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezarjarib Street, Isfahan Univeristy of Medical Sciences, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2017-06-08, 1396/03/18
Ethics committee reference number
IR.MUI.REC.1396.3.184
Health conditions studied
1
Description of health condition studied
Acute pancreatitis
ICD-10 code
K85
ICD-10 code description
Acute pancreatitis
Primary outcomes
1
Description
Increase in blood amylase
Timepoint
At baseline and within 24 hours after ERCP
Method of measurement
Blood sample
2
Description
Increase in blood lipase
Timepoint
At baseline and within 24 hours after ERCP
Method of measurement
Blood sample
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: By the end of the procedure, 20 ml of epinephrine 0.02% (Darupakhsh; Iran) was sprayed on the papilla for a minute.
Category
Prevention
2
Description
Control group: By the end of the procedure, 20 ml normal saline was sprayed on the papilla for a minute
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Laleh Raeisi Bidakani
Street address
Alzahra Hospital, Shohadayeh Sofe Avenue
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
raesibidakanilaleh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
لاله رئیسی بیدکانی
Street address
Isfahan University of Medical Sciences, Hezarjarib Avenue
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
raesibidakanilaleh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Laleh Raeisi Bidakani
Position
Internal Medicine Professionalist
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Hezarjarib Avenue, Isfahan University of Medical Sciences, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8196136573
Phone
+98 31 3444 7707
Fax
Email
raesibidakanilaleh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Laleh Raeisi Bidakani
Position
Internal Medicine Professionalist
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Hezarjarib Avenue, Isfahan University of Medical Sciences, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8196136573
Phone
+98 31 3444 7707
Fax
Email
raesibidakanilaleh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Laleh Raeisi Bidakani
Position
Internal Medicine Professionalist
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Hezarjarib Avenue, Isfahan University of Medical Sciences, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8196136573
Phone
+98 31 3444 7707
Fax
Email
raesibidakanilaleh@gmail.com
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
Undecided - It is not yet known if there will be 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 the data of the study are available after the documentation and publication of the study
When the data will become available and for how long
Following the publication of the study
To whom data/document is available
The university students who design a similar studies
Under which criteria data/document could be used
Fo publication of similar articles and by coordination with the tutor
From where data/document is obtainable
They should be in touch with the tutor using email
What processes are involved for a request to access data/document
After connection with the tutor and by his acceptance the data is available