Efficacy of Oral Tacrolimus Combined With Rectal Indomethacin Compared to Rectal Indomethacin Alone in Reducing Pancreatitis After ERCP
Design
In the form of a clinical trial, based on previous similar studies, 78 patients (including 8 patients who dropped out during sampling) were randomly assigned to one of two groups (control group) (1) rectal indomethacin and 2) in terms of pancreatitis after ARCP. The intervention group will be assigned tacrolimus along with rectal indomethacin. Indomethacin 100 mg rectal will be administered once and at the same time as the start of ARCP.
Settings and conduct
All referring patients have the conditions to enter the pain test of Qaim and Imam Reza hospitals in Mashhad
Participants/Inclusion and exclusion criteria
Normal amylase and lipase levels before ARCP
• All patients who meet the criteria for performing IRCP
• Having informed consent
• Full consciousness
• No contraindications for tacrolimus
Intervention groups
Patients with study conditions and referrals for ercp, and giving tacrolimus tablets along with rectal indomethacin and checking the reduction of pancreatitis
Main outcome variables
Reduction of serum amylase and lipase of patients and reduction of pancreatitis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240327061376N1
Registration date:2024-06-10, 1403/03/21
Registration timing:retrospective
Last update:2024-06-10, 1403/03/21
Update count:0
Registration date
2024-06-10, 1403/03/21
Registrant information
Name
morteza valayi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3876 7903
Email address
valayimorteza@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-20, 1403/01/01
Expected recruitment end date
2024-06-04, 1403/03/15
Actual recruitment start date
2024-04-03, 1403/01/15
Actual recruitment end date
2024-05-28, 1403/03/08
Trial completion date
2024-07-22, 1403/05/01
Scientific title
Efficacy of Oral Tacrolimus Combined With Rectal Indomethacin Compared to Rectal Indomethacin Alone in Reducing Pancreatitis After ERCP
Public title
The effect of oral tacrolimus with rectal indomethacin to reduce pancreatitis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Normal amylase and lipase levels before ARCP
All patients who meet the criteria for performing RCPI
Having informed consent
Full consciousness
• No contraindications for tacrolimus
Exclusion criteria:
Pregnancy or breastfeeding
History of previous angina, myocardial infarction, cerebral ischemia during the previous three months
• Chronic heart, liver and kidney failure
Referral with manifestations of acute pancreatitis or chronic pancreatitis
• Tacrolimus contraindications include: uncontrolled blood pressure, uncontrolled infections, hypomagnesemia, hypocalcemia, hyperkalemia, and any type of malignancy.
• Heart rhythm disorders
• Thrombosis and DVT
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
78
Actual sample size reached:
78
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be allocated in a blocked random manner.to one of the two control (indomethacin rectal) and intervention (tacrolimus along with rectal indomethacin) groups . The randomization method will be random manner and the randomization unit will be considered as a block of four. The randomization tool and random sequence construction will be done using the random number table and through the www.randomization.com site. In this study, two intervention and control groups were identified with the letters A and B. Therefore, for random blocks, 6 modes of moving them are possible and the following formula will be used (4! (1*2*3*4) / [2! (1*2)] *[4-2]! = 3*4/2 = 6 states)
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Medicine- Mashhad University of Medical Sciences
Street address
Unit 3, Plate 64, Razavi, 37, Razavi Blvd., Mashhad
City
MASHHAD
Province
Razavi Khorasan
Postal code
9177974863
Approval date
2024-02-20, 1402/12/01
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1402.520
Health conditions studied
1
Description of health condition studied
Pancreatitis after ERCP
ICD-10 code
K85.8
ICD-10 code description
Other acute pancreatitis
Primary outcomes
1
Description
Development of pancreatitis following ercp
Timepoint
24 hours after ERCP
Method of measurement
Control of serum amylase and lipase levels of patients after the procedure in approved laboratories
2
Description
Reduction of pancreatitis by giving oral tacrolimus with rectal indomethacin after ercp
Timepoint
24 hours after ERCP
Method of measurement
Control of amylase and lipase levels in patients after ERCP
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: Patients who meet the conditions to enter the study before the procedure are given oral tacrolimus along with rectal indomethacin and will be monitored for pancreatitis 24 hours later.
Category
Prevention
2
Description
Control group: patients undergoing ERCP, only rectal indomethacin is used
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem and Imam Reza hospitals of Mashhad, endoscopy departments
Full name of responsible person
Morteza Valai
Street address
Unit 3, Plate 64, Razavi, 37, Razavi Blvd., Mashhad
City
MASHHAD
Province
Razavi Khorasan
Postal code
9177974863
Phone
+98 915 550 4858
Email
valayimorteza@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Taskheti
Street address
University Street, Mashhad
City
MASHHAD
Province
Razavi Khorasan
Postal code
٩٩١٩١ ٩١٧٧٨
Phone
+98 51 3879 5031
Fax
+98 51 3833 6827
Email
p.relations@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
Morteza Valai
Position
Gastroenterology graduate student
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Mashhad, Razavi Razavi Blvd. 37, Block 64, Unit 3
City
MASHHAD
Province
Razavi Khorasan
Postal code
9177974863
Phone
+98 51 3876 7903
Email
valayimorteza@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Morteza Valai
Position
Gastroenterology graduate student
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
No. 64, Unit 3, Razavi Razavi Blvd., 37, Mashhad
City
MASHHAD
Province
Razavi Khorasan
Postal code
948873152
Phone
+98 51 3876 7903
Email
valayimorteza@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Morteza Valai
Position
Gastroenterology graduate student
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Razavi Razavi Blvd. 37, Block 64, Unit 3, Mashhad
City
MASHHAD
Province
Razavi Khorasan
Postal code
1395875233
Phone
+98 51 3876 7903
Email
valayimorteza@gmail.com
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
Not applicable
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