The comparison of efficacy of oral oral N-acetylcysteine (NAC) with rectal indomethacin in prevention of pancreatitis after ERCP
Design
This is a multicenter clinical trial study with parallel groups, double-blinded randomized, will be conducted on 280 patients undergoing ERCP. Assignment of patients to the study groups will be done by random-numbers table and using computer.
Settings and conduct
This multicenter study will be performed on patients undergoing ERCP in Imam Khomeini and Golestan hospitals, Ahvaz. At least 280 patients will be randomly assigned to one of four treatment groups. The patients and experimenters will not know about type of treatment and patient grouping and thus until the end of trial the study will be remained double-blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients who candidate for endoscopic retrograde cholangiopancreatography (ERCP), including patients with jaundice due to biliary obstruction; imaging findings indicating pancreatic duct obstruction; consent to participate in the study. Exclusion criteria: history of pancreatitis before ERCP; uncontrolled diabetes; triglyceride more than 1000 mg/dL.
Intervention groups
In first group, N-acetylcysteine 1200 mg (Osvah Pharmaceutical Company, Iran Exir CO., Iran) is drunk with 150 cc water two hours before endoscopic retrograde cholangiopancreatography (ERCP) (the appearance of the drug after dissolving in water is colorless and has no difference with control group). In the second group, 150 cc water is given as a placebo before ERCP. In the third group, patients will receive 100 mg rectal indomethacin (Abureihan Company, Iran) before ERCP. In the fourth group, oral acetylcysteine (1200 mg) with rectal indomethacin (100 mg) are given before ERCP.
Main outcome variables
Incidence of pancreatitis; severity of pancreatitis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201222049798N1
Registration date:2020-12-29, 1399/10/09
Registration timing:prospective
Last update:2020-12-29, 1399/10/09
Update count:0
Registration date
2020-12-29, 1399/10/09
Registrant information
Name
Ali akbar Abravesh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3222 2922
Email address
abravesh.aa@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-19, 1399/12/01
Expected recruitment end date
2021-09-21, 1400/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of efficacy of oral oral N-acetylcysteine (NAC) with rectal indomethacin in prevention of post ERCP pancreatitis
Public title
Efficacy of oral NAC and rectal indomethacin in prevention pancreatitis after ERCP
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who candidate for endoscopic retrograde cholangiopancreatography (ERCP) including patients with jaundice due to biliary obstruction and imaging findings indicating pancreatic duct obstruction
Consent to participate in the study
Exclusion criteria:
History of pancreatitis before ERCP
Uncontrolled diabetes,
Triglyceride more than 1000 mg/dL
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
280
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be assigned into four groups by simple randomization method. Allocation of patients to the study groups will be done by random-numbers table and using computer, and on this basis patients will be included in one of the four treatment groups before starting ERCP. The implementation of the random allocation sequence occurs without knowledge of which patient will receive which treatment.
Blinding (investigator's opinion)
Double blinded
Blinding description
Intervention (receiving oral N-acetylcysteine, rectal indomethacin, N-acetylcysteine with rectal indomethacin or water) and patient evaluation will be carried out by a physician who is blinded to both treatment groups. Also patients and statistical analyzer will not know about patient grouping.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Approval date
2020-12-08, 1399/09/18
Ethics committee reference number
IR.AJUMS.HGOLESTAN.REC.1399.120
Health conditions studied
1
Description of health condition studied
Pancreatitis
ICD-10 code
K85.9
ICD-10 code description
Acute pancreatitis, unspecified
Primary outcomes
1
Description
Incidence of pancreatitis
Timepoint
24 hours after ERCP
Method of measurement
Based on the amount of amylase increase (more than 276 IU/di) and the presence of abdominal pain and patient report of abdominal pain after ERCP
2
Description
Severity of pancreatitis
Timepoint
Duration of hospitalization
Method of measurement
Based on the number of hospitalization days (mild pancreatitis: hospitalization less than 4 days, moderate pancreatitis: 4 to 10 days; severe pancreatitis: more than 10 days)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: N-acetylcysteine 1200 mg (Osvah Pharmaceutical Company, Iran Exir CO., Iran) is drunk with 150 cc water two hours before endoscopic retrograde cholangiopancreatography (ERCP) (the appearance of the drug after dissolving in water is colorless and has no difference with control group).
Category
Prevention
2
Description
Control group: 150 cc water is given as a placebo before ERCP
Category
Prevention
3
Description
Intervention group: patients will receive 100 mg rectal indomethacin (Abureihan Company, Iran) before ERCP.
Category
Prevention
4
Description
Intervention group: oral acetylcysteine (1200 mg) with rectal indomethacin (100 mg) are given before ERCP.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Ali Akbar Abravesh
Street address
Imam Khomeini Hospital, Azadegan St.
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3222 2818
Email
aa.abravesh@yahoo.com
2
Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
Ali Akbar Abravesh
Street address
Golestan Hospital, Faevardin Ave., Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3374 3001
Email
aa.abravesh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badavi
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3001 3374
Email
badavim@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Ali akbar Abravesh
Position
Adult gastroentrology fellowship
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Imam Khomeini Hospital, Azadegan St.
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3222 2922
Fax
Email
abravesh.aa@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ali akbar Abravesh
Position
Adult gastroentrology fellowship
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Imam Khomeini Hospital, Azadegan St.
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3222 2922
Fax
Email
abravesh.aa@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ali akbar Abravesh
Position
Adult gastroentrology fellowship
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Imam Khomeini Hospital, Azadegan St.
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3222 2922
Fax
Email
abravesh.aa@ajums.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