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IRCT20200825048515N35 IRCT 2021-06-11 Shahre-kord University of Medical Sciences The effectiveness of epinephrine spray on papillae for prevention of pancreatitis Evaluation the effectiveness of epinephrine spray on papillae in prevention of post-Endoscopic retrograde cholangiopancreatography(ERCP) pancreatitis 2021-06-20 anticipated 164 Complete https://irct.ir/trial/56468 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, 164 eligible patients will be randomly selected. Then random numbers are created by computer software "Random Allocation". These numbers are randomly labeled A (Control group) and B (Intervention group). Each number is written on paper and placed in an envelope. Then each patient is asked to choose an envelope from among the envelopes. According to the selected envelope, the patient will be assigned to one of the two groups A or B, Blinding description: In this study, the two sprays of epinephrine and normal saline of the same color and shape are prepared by the pharmacist and placed in coded packages and given to the doctor. He prescribes them without knowing the type of each drug. Also, the person recording the patient's clinical information and the statistical analyst will not be aware of the type of intervention. 3 Biliary pancreatitis. Intervention 1: Control group: Patients in this group receive 50 mg indomethacin suppository, before the ERCP. In addition, during ERCP and before cannulation, the normal saline is sprayed locally on the major papillae by a sprinkler catheter and then completely removed from the patient after the endoscope intervention. Intervention 2: Intervention group: Patients in this group receive 50 mg indomethacin suppository, before the ERCP. In addition, during ERCP and before cannulation, the epinephrine is sprayed locally on the major papillae by a sprinkler catheter and then completely removed from the patient after the endoscope intervention. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Mohammad Karami
Shahrekord University of Medical Sciences, Kashani street,
Shahrekord Iran (Islamic Republic of) 8815713471 +98 38 3333 0061 Bahman_salem@yahoo.com Shahre-kord University of Medical Sciences scientific Mohammad Karami
Shahrekord University of Medical Sciences, Kashani street,
Shahrekord Iran (Islamic Republic of) 8815713471 +98 38 3333 0061 Bahman_salem@yahoo.com Shahre-kord University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Age 18 years or older Having an intact papillae No deformity ‌ Papilla Consent to participate in the study 18 years no limit Both Having acute pancreatitis Having chronic pancreatitis with an acute exacerbation Above normal serum amylase level or lipase level (> 200 units per liter) Having bile duct cancer Previous ERCP history or papilla manipulation Allergy to epinephrine K85.1 Biliary acute pancreatitis Placebo Treatment - Drugs Control group: Patients in this group receive 50 mg indomethacin suppository, before the ERCP. In addition, during ERCP and before cannulation, the normal saline is sprayed locally on the major papillae by a sprinkler catheter and then completely removed from the patient after the endoscope intervention. Intervention group: Patients in this group receive 50 mg indomethacin suppository, before the ERCP. In addition, during ERCP and before cannulation, the epinephrine is sprayed locally on the major papillae by a sprinkler catheter and then completely removed from the patient after the endoscope intervention. Frequency of cannulation. Timepoint: 24 hours after ERCP operation. Method of measurement: Observation. Incidence of pancreatitis. Timepoint: 24 hours after ERCP operation. Method of measurement: Examination and testing of amylase lipase. Shahrekord University of Medical Sciences Approved 2020-11-23 Ethics committee of Shahre-Kord University of Medical Sciences Shahrekord University Of Medical Sciences, Kashani Blvd Shahrekord Isfehan Iran (Islamic Republic of)