Determination of the Effect of Diclofenac Suppository on the Therapy of Acute Biliary Pancreatitis
Design
Clinical trial with a control group and parallel group trial and double blinded. The sample size is 80 people with simple randomization
Settings and conduct
This is a clinical trial study that will be carried out at Kowsar Hospital in Sanandaj. After dividing the groups, in the case group, diclofenac suppository 100 mg every 8 hours will give to the patient until the day before the operation , and in the control group placebo suppository is given to the patient. Other treatments are similar for both groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1) Acute pancreatitis, which in its definition should be
There are at least two criteria of the three following criteria: a) pain in the upper abdomen, b) serum amylase or lipase> 3 times normal, or c) acute pancreatitis imaging features in CT or MRI .
2) A biliary cause based on the minimum of the following conditions:
A. Biliary stone or biliary sludge in imaging (any type)
B) A dilated common bile duct in the imaging that is> 8 mm in
Patients ≤ 75 years or> 10 mm in patients> 75 years of age
C) Alanine aminotransferase more than twice as normal.
3) informed consent of the patient.
4) Age more than 18 years
Non-compliance criteria:
1) Cholangitis
2) Pancreatitis for other causes such as alcohol abuse, metabolic causes (hyperthermia or hypercalcemia), medication, trauma, etc.
3) Chronic pancreatitis
4) Pregnancy
Intervention groups
In the intervention group, patients get diclofenac suppository 100 mg every 8 hours until the day before surgery. in the control group, placebo suppository will be added to the treatment with same condition in the case group
Main outcome variables
death
Organ failure
Necrotizing pancreatitis
Cholangitis (Cholangitis in the course of treatment)
The need for surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181028041485N1
Registration date:2019-02-12, 1397/11/23
Registration timing:retrospective
Last update:2019-02-12, 1397/11/23
Update count:0
Registration date
2019-02-12, 1397/11/23
Registrant information
Name
Morteza Yousefi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3366 4648
Email address
yousefi.m@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-03-20, 1395/12/30
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
2017-03-20, 1395/12/30
Actual recruitment end date
2018-03-20, 1396/12/29
Trial completion date
2018-04-08, 1397/01/19
Scientific title
efficacy of Diclofenac suppository on treatment of acute biliary pancreatitis
Public title
efficacy of diclofenac on pancreatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Acute pancreatitis, which in its definition should have at least two criteria of the following three criteria: a) pain in the upper abdomen, b) serum amylase or lipase> 3 times of normal, orc) acute pancreatitis features In computer tomography (CT) or magnetic resonance imaging (MRI)
A biliary cause based on at least one of the following conditions: a) gallstone or sludge in the imaging (any type); b) common bile duct > 8 mm in patients <75 years of age or> 10 mm in patients> 75 years of age. C) Alanine aminotransferase (AST) more than twice as normal;
Conscious informed consent;
Age older than 18 years.
Exclusion criteria:
Cholangitis
Pancreatitis for other causes such as alcohol abuse, metabolic causes (hyperthermia or hypercalcemia), medication, trauma, etc.
Chronic pancreatitis
Pregnancy
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
80
Actual sample size reached:
80
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization was Simple randomization. In this way, we divided the patients who had the inclusion criteria, into two groups with a closed envelope
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients who will be present in the study will take a Suppository an will be supplemented by nurses based on which group they will be in, and the patient will not know what Suppository are given to him/her. In the case of the statistical advisor in the same way, only the data will be analyzed between the two groups and statistical advisor will not be known which group get the placebo.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kurdistan University of Medical Sciences
Street address
Kowsar hospital, Pasdaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
6616894581
Approval date
2017-05-01, 1396/02/11
Ethics committee reference number
IR.MUK.REC.1396/212
Health conditions studied
1
Description of health condition studied
Pancratitis
ICD-10 code
K85.1
ICD-10 code description
Biliary acute pancreatitis
Primary outcomes
1
Description
Mortality
Timepoint
End of the research
Method of measurement
Number of people
2
Description
Organ failure
Timepoint
End of the research
Method of measurement
Lab test & physical exam
3
Description
Necrotizing pancratitis
Timepoint
End of the research
Method of measurement
Abdominal & pelvic CT scan
4
Description
Bacteremia
Timepoint
During the study
Method of measurement
Lab test
5
Description
Cholangitis
Timepoint
During the study
Method of measurement
Lab test & physical exam
6
Description
Need for necrozectomy surgery
Timepoint
During the study
Method of measurement
Abdominal & pelvic CT scan
7
Description
Number of ICU & hospital admissions days
Timepoint
End of the research
Method of measurement
Number of days
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Diclofenac Suppository 100 mg every 8 hours will be added until symptom improvement and the day before surgery.
Category
Treatment - Drugs
2
Description
Control group: Placebo Suppository every 8 hours will be added until the day before surgery.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Kowsar hospital
Full name of responsible person
Farhang Safarnezhad
Street address
Kowsar hospital, Pasdaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
6616894581
Phone
+98 87 3361 1306
Email
Yousefi.M@muk.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Farzin Razaei
Street address
Deputy of research and technology, kurdistan University of medical scince, Pasdaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
6616894231
Phone
+98 87 3366 4645
Email
Yousefi.M@Muk.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sanandaj University of Medical Sciences
Proportion provided by this source
50
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
Sanandaj University of Medical Sciences
Full name of responsible person
Morteza Yousefi
Position
Rezident of general surgery
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Departmant of general surgery, Kowsar hospital, Pasdaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
661689581
Phone
+98 87 3361 1258
Email
Yousefi.M@Muk.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Morteza Yousefi
Position
Rezident of general surgery
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Departmant of general surgery, Kowsar hospital, Pasdaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
6616894581
Phone
+98 87 3361 1258
Email
Yousefi.M@Muk.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Morteza Yousefi
Position
Rezident of general surgery
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Departmant of general surgery, Kowsar hospital, Pasdaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
6616894581
Phone
+98 87 3361 1258
Email
Yousefi.M@Muk.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
Not applicable
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
Not applicable
Title and more details about the data/document
All collected data is shareable and has no limitations
When the data will become available and for how long
The access period will be available after printing the results
To whom data/document is available
Researchers working in academia
Under which criteria data/document could be used
There is no limitation
From where data/document is obtainable
Deputy of Research of Kurdistan University of Medical Sciences
What processes are involved for a request to access data/document
The data are visible after request from the deputy of research and after confirmation of the request within one month