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IRCT20201222049798N1 IRCT 2020-12-29 Ahvaz University of Medical Sciences Efficacy of oral NAC and rectal indomethacin in prevention pancreatitis after ERCP The comparison of efficacy of oral oral N-acetylcysteine (NAC) with rectal indomethacin in prevention of post ERCP pancreatitis 2021-02-19 anticipated 280 Complete https://irct.ir/trial/53192 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, 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 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. 3 Pancreatitis. Intervention 1: 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). Intervention 2: Control group: 150 cc water is given as a placebo before ERCP. Intervention 3: Intervention group: patients will receive 100 mg rectal indomethacin (Abureihan Company, Iran) before ERCP. Intervention 4: Intervention group: oral acetylcysteine (1200 mg) with rectal indomethacin (100 mg) are given before ERCP. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information.
public Ali akbar Abravesh
Imam Khomeini Hospital, Azadegan St.
Ahvaz Iran (Islamic Republic of) 6193673111 +98 61 3222 2922 abravesh.aa@ajums.ac.ir Ahvaz University of Medical Sciences scientific Ali akbar Abravesh
Imam Khomeini Hospital, Azadegan St.
Ahvaz Iran (Islamic Republic of) 6193673111 +98 61 3222 2922 abravesh.aa@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) 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 18 years no limit Both History of pancreatitis before ERCP Uncontrolled diabetes, Triglyceride more than 1000 mg/dL K85.9 Acute pancreatitis, unspecified Prevention Prevention Prevention Prevention 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). Control group: 150 cc water is given as a placebo before ERCP Intervention group: patients will receive 100 mg rectal indomethacin (Abureihan Company, Iran) before ERCP. Intervention group: oral acetylcysteine (1200 mg) with rectal indomethacin (100 mg) are given before ERCP. 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. 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). Ahvaz University of Medical Sciences Approved 2020-12-08 Ethics committee of Ahvaz Jundishapur University of Medical Sciences Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd. Ahvaz Khouzestan Iran (Islamic Republic of)