Effect of intravenous somatostatin on prevention of pancreatitis after ERCP (Endoscopic Retrograde Cholangio-Pancreatography) in comparison with control group
Determination and comparison of PEP(post-ERCP Pancreatitis) incidence in patients receiving prophylactic intravenous bolus somatostatin plus rectal diclofenac versus placebo plus rectal diclofenac.
Design
Clinical trial with intervention and control groups, double blind, randomized, phase three.
Randomization:
Random block A, B.
Randomization Unit: Individual.
Randomization tool: random number table.
The operating physician, assistant and patient will not be aware of any syringe content.
Sample size:
50 patients in control group and 50 patients in intervention group.
Settings and conduct
Participants will be randomly divided into two groups of patients and controls. The operating physician, assistant, and patient will not be aware of any needle syringes (double blind). Randomly block A, B, individual randomization unit, table randomization tool. The drug syringe contains 250 micrograms of somatostatin and the placebo syringe contains distilled water.
The endoscopy unit of Firoozgar Hospital will be located in Tehran.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age over 18 years ;
Ability to sign consent ;
Intact papillae ;
No contraindication for somatostatin and diclofenac ;
Having an ERCP indication ;
Non-inclusion:
Sphincterotomy ;
Acute pancreatitis ;
Basic amylase above 200 ;
Allergy to somatostatin and diclofenac ;
Intervention groups
Intervention group: intravenous injection of 250 μg Somatostatin
Control group: drug injection (distilled water)
Main outcome variables
Acute pancreatitis after ERCP
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191231045969N1
Registration date:2020-02-18, 1398/11/29
Registration timing:registered_while_recruiting
Last update:2020-02-18, 1398/11/29
Update count:0
Registration date
2020-02-18, 1398/11/29
Registrant information
Name
Mehdi Nikkhah
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8214 1711
Email address
nikkhah.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-27, 1397/06/05
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of intravenous somatostatin on prevention of pancreatitis after ERCP (Endoscopic Retrograde Cholangio-Pancreatography) in comparison with control group
Public title
The effect of intravenous somatostatin on prevention of pancreatitis after ERCP (Endoscopic Retrograde Cholangio-Pancreatography)
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
Ability to sign consent
Intact papillae
No contraindication for somatostatin and diclofenac
Having an ERCP indication
Exclusion criteria:
Sphincterotomy
Acute pancreatitis
Basic amylase above 200
Allergy to somatostatin and diclofenac
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization Method: Block A, B is random. Patients will be placed in pre-arranged charts in which A, B are listed, respectively, at the time of study, thereby prescribing for block A, the syringe containing the drug, and for block B, the syringe containing the drug.
The operating physician, assistant, and patient will not be aware of any syringe content and the syringe code will be written to the file (double blind).
Randomization Unit: Individual
Randomization Tool: Table
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients will be randomly assigned to block A and B randomly with the table randomization tool.
The syringe code will be written to the file.
The operating physician, assistant and patient will not be aware of any syringe content. (Double blind).
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, next to Milad Tower, Hemat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2018-08-26, 1397/06/04
Ethics committee reference number
IR.IUMS.REC.1397.290
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
Acute pancreatitis after ERCP
Timepoint
24 hours after ERCP operation
Method of measurement
Examination and testing of lipase amylase
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Intravenous (distilled water) injection, 5cc intravenous injection, a syringe (no content and only one code insert) given to physician assistant to slow it for 1 to 2 minutes simultaneously Injections for the patient. The name of the distilled water company is SUPA and its chemical compound is H2O.
Category
Placebo
2
Description
Intervention group: Intravenous injection of 250 μg somatostatin (250 μg somatostatin dissolved in 5 ml distilled water), a syringe (without mentioning content and with only one code insert) given to the physician assistant slowly Inject 1 to 2 minutes with the cannulation for the patient. The manufacturer's name is somatostatin consumable, Eumedica.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Firoozgar hospital
Full name of responsible person
Mehdi Nikkha
Street address
Firoozgar Hospital, Beh Afarin Street, Vali Asr Square
City
Tehran
Province
Tehran
Postal code
1593748711
Phone
+98 21 8893 7383
Fax
+98 21 8893 7383
Email
nikkhah.m@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Abbas Motevalian
Street address
Iran University of Medical Sciences, next to Milad Tower, Hemat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2504
Email
amotevalian@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Mehdi Nikkhah
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Firoozgar Hospital, Beh Afarin Street, Vali Asr Square
City
Tehran
Province
Tehran
Postal code
1593748711
Phone
+98 21 8893 7383
Email
Nikkhah.m@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mehdi Nikkhah
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Firoozgar Hospital, Beh Afarin Street, Vali Asr Square
City
Tehran
Province
Tehran
Postal code
1593748711
Phone
+98 21 8893 7383
Email
nikkhah.m@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mehdi Nikkhah
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Firoozgar Hospital, Beh Afarin Street, Vali Asr Square
City
Tehran
Province
Tehran
Postal code
1593748711
Phone
+98 21 8893 7383
Email
Nikkhah.m@iums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available