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IRCT20230314057717N1 IRCT 2023-04-15 Shahid Beheshti University of Medical Sciences Review of the least complicated technique of bile duct cannulation in difficult ERCP cases ERCP Comparison of two technical methods of fistulotomy over a pancreatic guide-wire and trans-pancreatic sphincterotomy in difficult cases of ERCP with advertent or inadvertent PD cannulation 2023-04-21 anticipated 200 Complete https://irct.ir/trial/69385 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are assigned to two groups using the random block method. The number of blocks will be 4 and each block will have three patients based on the order of entry are studied. Random allocation of blocks of patients to two treatment groups It will be done through Sealed Envelope online software. Randomized list The blocks are placed in sealed envelopes and will be provided to the endoscopist daily, Blinding description: The patients who are in each group do not know about which biliary duct cannulation method they have been placed in. Also, in order to avoid the bias of the analyst, he is not aware of the allocation of the study groups and the data is provided to him in the form of code. N/A Obstruction of the bile ducts. Intervention 1: Intervention group: In the first group, the bile duct of the patients will be cannulated with the fistulotomy over the pancreatic guidewire technique. Patients will undergo ERCP in one session and its duration will be between 20 and 60 minutes depending on the difficulty of cannulation. First, a stent will be inserted in the duct of the patient's pancreas. The guidewire will then pass over the stent, and through the pancreas, into the bile duct. Intervention 2: Intervention group: In the second group, the bile duct of the patients will be cannulated with the trans pancreatic fistulotomy technique. Patients will undergo ERCP in one session and its duration will be between 20 and 60 minutes depending on the difficulty of cannulation. In this method, the endoscopist enters the pancreas with a guide wire and enters the bile duct by creating a hole in the pancreas. Yes - There is a plan to make this available What will be shared: The statistical analysis plan, study design and information on main outcomes will be shared When: After publishing the article To whom: Researchers, medical students, professors, and doctors Conditions: If used for further research and in compliance with the principle of referencing Where to obtain: corresponding author ŮŽAmir Sadeghi amirsadeghimd@yahoo.com How to obtain: Send the request to the responsible author and outline the reason for the request Comments:
public Ehsan Hosein zadeh
Arabi street, Velenjak
Tehran Iran (Islamic Republic of) 3816149369 +98 21 2243 2540 hosseinzadehehsan@yahoo.com Shahid Beheshti University of Medical Sciences scientific Amir Sadeghi
Arabi street, Velenjak
Tehran Iran (Islamic Republic of) 3816149369 +98 21 2243 2540 amirsadeghimd@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients with acute pancreatitis (increased amylase and lipase 3 times more than normal) Patients with gallstones on ultrasound suspected to have CBD stones (symptomatic gallstone disease) Biochemical findings (increased AST, ALP, ALT or bilirubin) Ultrasound findings (diagnosis of stones or enlargement of the CBD) that indicate a CBD stone or blockage of the CBD 18 years no limit Both Patients with severe coagulopathy or previous Roux-en-y gastric surgery Gastrogenostomy pregnancy Contrast sensitivity History of previous sphincterotomy K83.1 Obstruction of bile duct Treatment - Other Treatment - Other Intervention group: In the first group, the bile duct of the patients will be cannulated with the fistulotomy over the pancreatic guidewire technique. Patients will undergo ERCP in one session and its duration will be between 20 and 60 minutes depending on the difficulty of cannulation. First, a stent will be inserted in the duct of the patient's pancreas. The guidewire will then pass over the stent, and through the pancreas, into the bile duct. Intervention group: In the second group, the bile duct of the patients will be cannulated with the trans pancreatic fistulotomy technique. Patients will undergo ERCP in one session and its duration will be between 20 and 60 minutes depending on the difficulty of cannulation. In this method, the endoscopist enters the pancreas with a guide wire and enters the bile duct by creating a hole in the pancreas. Success rate of bile duct cannulation. Timepoint: At the time of cannulation by the endoscopist. Method of measurement: Visual diagnosis of the endoscopist by observing the cannulation process on the monitor. Bleeding. Timepoint: during or after the procedure. Method of measurement: Clinical evidence of bleeding or hemoglobin drop. Pancreatic. Timepoint: 6 hours after the procedure. Method of measurement: Amylase and/or lipase 3 times higher than normal 24 hours after the procedure with abdominal pain. Perforation of bile duct. Timepoint: during the procedure. Method of measurement: Clinical evidence of perforation of the lateral or medial wall of the bile duct. Cholangitis. Timepoint: 6 hours after the procedure. Method of measurement: When the bile duct becomes infected (abdominal pain and fever over 38 degrees). Temperature. Timepoint: 4 hours after the completion of the procedure. Method of measurement: thermometer. Amylas. Timepoint: before the procedure and 3 hours after the procedure. Method of measurement: blood test (CBC). Lipas. Timepoint: before the procedure and 3 hours after the procedure. Method of measurement: blood test (CBC). Shahid Beheshti University of Medical Sciences Approved 2023-03-11 Ethics Committee of Gastroenterology and Liver Research Institute of Shahid Beheshti University of M arabi street, Velenjak Tehran Tehran Iran (Islamic Republic of)