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IRCT20191231045969N1 IRCT 2020-02-18 Iran University of Medical Sciences The effect of intravenous somatostatin on prevention of pancreatitis after ERCP (Endoscopic Retrograde Cholangio-Pancreatography) Effect of intravenous somatostatin on prevention of pancreatitis after ERCP (Endoscopic Retrograde Cholangio-Pancreatography) in comparison with control group 2018-08-27 anticipated 100 Complete https://irct.ir/trial/44698 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization Method: Block A, B is random. Patients will be placed in pre-arranged charts in which A, B are listed, respectively, at the time of study, thereby prescribing for block A, the syringe containing the drug, and for block B, the syringe containing the drug. The operating physician, assistant, and patient will not be aware of any syringe content and the syringe code will be written to the file (double blind). Randomization Unit: Individual Randomization Tool: Table, Blinding description: Patients will be randomly assigned to block A and B randomly with the table randomization tool. The syringe code will be written to the file. The operating physician, assistant and patient will not be aware of any syringe content. (Double blind). 3 Acute pancreatitis. Intervention 1: Control group: Intravenous (distilled water) injection, 5cc intravenous injection, a syringe (no content and only one code insert) given to physician assistant to slow it for 1 to 2 minutes simultaneously Injections for the patient. The name of the distilled water company is SUPA and its chemical compound is H2O. Intervention 2: Intervention group: Intravenous injection of 250 μg somatostatin (250 μg somatostatin dissolved in 5 ml distilled water), a syringe (without mentioning content and with only one code insert) given to the physician assistant slowly Inject 1 to 2 minutes with the cannulation for the patient. The manufacturer's name is somatostatin consumable, Eumedica. 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 No more information.
public Mehdi Nikkhah
Firoozgar Hospital, Beh Afarin Street, Vali Asr Square
Tehran Iran (Islamic Republic of) 1593748711 +98 21 8893 7383 Nikkhah.m@iums.ac.ir Iran University of Medical Sciences scientific Mehdi Nikkhah
Firoozgar Hospital, Beh Afarin Street, Vali Asr Square
Tehran Iran (Islamic Republic of) 1593748711 +98 21 8893 7383 nikkhah.m@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Age over 18 years Ability to sign consent Intact papillae No contraindication for somatostatin and diclofenac Having an ERCP indication 18 years no limit Both Sphincterotomy Acute pancreatitis Basic amylase above 200 Allergy to somatostatin and diclofenac K85 Acute pancreatitis Placebo Treatment - Drugs Control group: Intravenous (distilled water) injection, 5cc intravenous injection, a syringe (no content and only one code insert) given to physician assistant to slow it for 1 to 2 minutes simultaneously Injections for the patient. The name of the distilled water company is SUPA and its chemical compound is H2O. Intervention group: Intravenous injection of 250 μg somatostatin (250 μg somatostatin dissolved in 5 ml distilled water), a syringe (without mentioning content and with only one code insert) given to the physician assistant slowly Inject 1 to 2 minutes with the cannulation for the patient. The manufacturer's name is somatostatin consumable, Eumedica. Acute pancreatitis after ERCP. Timepoint: 24 hours after ERCP operation. Method of measurement: Examination and testing of lipase amylase. Iran University of Medical Sciences Approved 2018-08-26 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, next to Milad Tower, Hemat Highway, Tehran Tehran Tehran Iran (Islamic Republic of)