Determining the application and effect of static samen solution in controlling bleeding caused by sphincterotomy in comparison with argon plasma coagulation method
Design
Clinical trial with control group and parallel groups, phase 3 on 25 patients, simple randomization method using closed door envelope
Settings and conduct
Patients with gastrointestinal bleeding due to sphincterotomy referred to the emergency department of Ghaem Hospital in Mashhad, are included in the study and then the patient will undergo one of the injections and coagulation with argon gas or treatment with static samen solution. Randomization is based on a table of random numbers and in order to hide the random allocation of groups, the method of sealed envelopes will be used. With each patient's visit, the envelopes are opened in order and the method of treatment is determined. The study is double-blind and the researcher and analyst are not aware of patient grouping.
Participants/Inclusion and exclusion criteria
Patients with gastrointestinal bleeding due to sphincterotomy referred to Ghaem Hospital emergency department
Intervention groups
In this study, patients with gastrointestinal bleeding due to sphincterotomy are examined. First, patients who meet the inclusion criteria are selected and after obtaining the patient's consent, treatment with static samen substance prepared in powder form is used. Before use, the powder is dissolved with distilled water (static samen solution) and poured on the bleeding site from a distance of 1-2 mm through a catheter that enters the endoscope. During endoscopy, the effect of the solution to stop the bleeding is examined. In the control group, the usual emergency treatment is performed by injection and coagulation with argon plasma.
Main outcome variables
The main variable is to stop bleeding due to sphincterotomy after using static samen solution up to 24 hours later.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140824018915N8
Registration date:2021-05-31, 1400/03/10
Registration timing:registered_while_recruiting
Last update:2021-05-31, 1400/03/10
Update count:0
Registration date
2021-05-31, 1400/03/10
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
Expected recruitment start date
2021-05-31, 1400/03/10
Expected recruitment end date
2021-07-01, 1400/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Samen eaista emulsion in the management of hemorrhage in ERCP due to sphinctrotomy in comparison with Argon plasma coagulation method
Public title
Efficacy of Samen eaista emulsion in the management of hemorrhage due to sphinctrotomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patients with upper gastrointestinal bleeding due to sphinctrotomy who will be admitted in emergency wards of Ghaem Hospital
Exclusion criteria:
Bleeding from esophageal or gastric varices
Bleeding from esophageal or gastric malignancy
Bleeding in a patient with coagulopathyHematologic
malignancy or renal failure
Age
From 15 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Investigator
Data analyser
Sample size
Target sample size:
25
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization with table of random numbers available at ''www.randomization.com'' website will be used. Numbers will be placed in sealed envelopes and each envelope is assigned to one participant placing them in one of the two groups
Blinding (investigator's opinion)
Double blinded
Blinding description
The intern and resident of the day are only aware of which person belongs to which group and the researcher and analyzer are not aware of the grouping.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9117699199
Approval date
2017-07-05, 1396/04/14
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1398.293
Health conditions studied
1
Description of health condition studied
Upper gastrointestinal bleeding
ICD-10 code
K25.0
ICD-10 code description
Acute gastric ulcer with hemorrhage
Primary outcomes
1
Description
Stop bleeding from wounds caused by sphincterotomy
Timepoint
After using static samen solution and 24 hours after intervention.
Method of measurement
Endoscopy
Secondary outcomes
1
Description
Need for re-endoscopy due to bleeding
Timepoint
Up to 4 weeks after the intervention
Method of measurement
questionnaire
Intervention groups
1
Description
Intervention group: In the intervention group, static samen substance prepared in powder form is used for treatment. Before use, the powder is dissolved with distilled water (static samen solution) and poured on the bleeding site from a distance of 1-2 mm through a catheter that enters the endoscope.Within a few seconds and during the same endoscopy, the effect of the solution to stop the bleeding is examined
Category
Treatment - Drugs
2
Description
Control group: In the control group, conventional emergency treatment is performed by injection and coagulation with plasma argon
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital Emergency
Full name of responsible person
Dr Mousalreza Hoseini
Street address
Ahmad Abad Ave, Ghaem hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3840 0000
Email
hoseinimr@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
345 - 91357
Phone
+98 51 3841 2081
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Mousalreza Hoseini
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Ahmad Abad Ave, Ghaem hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3801 2742
Email
hoseinimr@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mousalreza Hoseini
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Ahmad Abad Ave, Ghaem hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3801 2742
Email
hoseinimr@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mousalreza Hoseini
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Ahmad Abad Ave, Ghaem hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3801 2742
Email
hoseinimr@mums.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