Comparison of the effect of APC with epinephrine injection, Hemoclips and thermal probes methods in prevention of rebleeding in patients with gastric and duodenal ulcers
Comparison of the APC with epinephrine injection, Hemoclips, and thermal probes methods in the prevention of rebleeding in patients with gastric and duodenal ulcers
Design
This study is a double-blind, randomized, and prospective clinical trial. The total sample size is sixty patients. Patients are randomly divided into three groups. Patients will be unaware of the study process and the type of grouping and will be evaluated by a person who does not know the work process.
Settings and conduct
The field of work is clinical-internal. The place of study is Towhid Hospital, Sanandaj. Using block randomization method with a block size of 6. The sampling method of this study will be according to random allocation. The initial sampling method will be based on the entry criteria and will be available as sampling, but the method of randomly assigning people to different treatment groups will be based on block classification and random selection of blocks. The randomization tool uses randomization with GraphPad software. Patients, registrar, and patient evaluator are not aware of the process of randomization and placement of patients in groups (double-blind study).
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with upper gastrointestinal disease due to stomach and duodenal causes
Exclusion criteria: Patients who are treated with medication and without the need for endoscopic treatment methods are excluded from the study
Intervention groups
The first group undergoes the APC method, using argon probes and epinephrine injection. The second group is subjected to the method of using thermal probes. The third group is subjected to the hemoclips method, using stainless steel hemoclips.
Main outcome variables
Rebleeding
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190415043279N13
Registration date:2024-07-13, 1403/04/23
Registration timing:retrospective
Last update:2024-07-13, 1403/04/23
Update count:0
Registration date
2024-07-13, 1403/04/23
Registrant information
Name
Pezhman Sharifi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3324 9435
Email address
p.sharifi@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
2021-03-21, 1400/01/01
Actual recruitment end date
2022-08-23, 1401/06/01
Trial completion date
2022-08-23, 1401/06/01
Scientific title
Comparison of the effect of APC with epinephrine injection, Hemoclips and thermal probes methods in prevention of rebleeding in patients with gastric and duodenal ulcers
Public title
Comparison of the effect of APC with epinephrine injection, Hemoclips and thermal probes methods in prevention of rebleeding
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with upper gastrointestinal disease due to stomach and duodenal causes
Exclusion criteria:
Patients who are treated with medication and without the need for endoscopic treatment methods
Age
From 15 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Using block randomization method with a block size of 6. The sampling method of this study will be according to random allocation. The initial sampling method will be available based on the entry criteria and in the form of sampling, However, the method of random allocation of people to different treatment groups will be based on block classification and random selection of blocks. The randomization tool uses randomization with GraphPad software. Its link is: https://www.graphpad.com/quickcalcs/randomize2/
Participants will enter the study according to inclusion criteria and then will be divided into three groups according to the randomization table. Patients will be included in the study based on the inclusion criteria and based on the randomization table, they will be assigned to three treatment groups with APC, thermal probes, and hemoclips. Patients, registrar, and patient evaluator are not aware of the process of randomization and placement of patients in groups (double-blind study).
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients, registrar and patient evaluator are not aware of the process of randomization and placement of patients in groups (double-blind study).
Placebo
Not 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
Pasdaran Blvd., Kurdistan University of Medical Sciences
City
Sanandaj
Province
Kurdistan
Postal code
66117713446
Approval date
2018-07-04, 1397/04/13
Ethics committee reference number
IR.MUK.REC.1397.116
Health conditions studied
1
Description of health condition studied
Upper GI bleeding
ICD-10 code
K92.2
ICD-10 code description
Gastrointestinal hemorrhage, unspecified
Primary outcomes
1
Description
Rebleeding
Timepoint
24 hours after the intervention
Method of measurement
observing with Endoscope
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The first group undergoes the APC method, using argon probes and epinephrine injection. The APC method is performed using the APC device of the ERBE company (model APC2 VIO 200D), made in Germany, and the argon probes mm2.3 of the same company. Argon plasma coagulation (APC) is a new method that provides non-contact controlled electrocoagulation therapy.APC has been proven to be a safe and effective method for tissue coagulation and to prevent bleeding and achieve hemostasis.
Category
Treatment - Other
2
Description
Intervention group: The second group is subjected to the method of using thermal probes. Thermal probe devices produce heat, directly or indirectly, by passing an electric current through the tissue. Heat leads to edema, tissue protein coagulation, vasoconstriction, and indirect activation of the coagulation cascade and, as a result, hemostatic band coagulation. In the method of using thermal probes, the device of ERBE company, made in Germany, is used, and we use the Gold thermal probes of Boston Scientific company, which are installed and operated on the device.
Category
Treatment - Other
3
Description
Intervention group: The third group is subjected to the hemoclips method, using stainless steel hemoclips.The use of hemoclips is especially useful in active large vessels. After placing the hemoclips through the endoscope, it is increased from the sheath part and its piston handle is opened, and hemostasis is established by mechanical compression. The hemoclips are made by Olympus HX-201LR-135 company, which are placed using clip-like equipment and through an endoscope, with dimensions of 2.8 mm.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Liver and Digestive Clinic of Tohid Hospital, Sanandaj
Full name of responsible person
Dr Jalaleddin Naghshbandi
Street address
Tohid Hospital, Tohid Blvd
City
Sanandaj
Province
Kurdistan
Postal code
6616813131
Phone
+98 87 3328 6112
Fax
+98 87 3324 7855
Email
razhan537@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Dr. Afshin Maleki
Street address
Vice Chancellor for research of Kurdistan University of Medical Sciences, Pasdaran Blvd, Sanandaj, Iran.
City
Sanandaj
Province
Kurdistan
Postal code
6617713466
Phone
+98 87 3366 4645
Email
maleki43@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Kurdistan 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
Sanandaj University of Medical Sciences
Full name of responsible person
Dr Jalaleddin Naghshbandi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Tohid Hospital, Tohid Blvd
City
Sanandaj
Province
Kurdistan
Postal code
6616813131
Phone
+98 87 3328 6112
Email
razhan537@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Dr Jalaleddin Naghshbandi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Tohid Hospital, Tohid Blvd
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 87 3366 4645
Email
razhan537@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Pezhman Sharifi
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Microbiology
Street address
Research Department, Tohid Hospital, Tohid Blvd
City
Sanandaj
Province
Kurdistan
Postal code
6616813131
Phone
+98 87 3324 9435
Fax
+98 87 3324 9435
Email
p.sharifi@muk.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
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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