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

Comparison of two bile duct cannulation methods in difficult ERCP cases with advertent or inadvertent pancreatic cannulation.

Clinical trial with two parallel groups, double-blind and on 200 patients, trial phase is not applicable for this study. Randomization based on random blocks

ERCP candidate patients referred to Taleghani Hospital in Tehran, whose bile duct cannulation is difficult, are included in the study. One group is cannulated with fistulotomy over the pancreatic guidewire. The second group is cannulated with transpancreatic snephcterotomy technique. After the procedure, the patients will be evaluated in terms of complications and success rate of cannulation. The study is double-blind, so that the necessary information is provided to the patients regarding the study, it will be stated that there are two types of methods for their ERCP, but they will not know in which group and by which method they will undergo cannulation. Also, the data analyst does not know how to assign groups and results

Inclusion criteria: Patients with suspected acute biliary pancreatitis, biochemical findings, and ultrasound findings Exclusion criteria: cardiopulmonary disease and other systemic diseases that endanger anesthesia

In group 1, the bile duct will be cannulated with the fistulotomy over the PD guidewire. First, a stent will be placed in the duct of the pancreas. Then, the guidewire passes through the stent and enters the bile duct through the pancreas. In group 2, the bile duct will be cannulated with the trans pancreatic fistulotomy technique. the endoscopist enters the pancreas with a guide wire and enters the bile duct by creating a hole in the pancreas.

cannulation success rate; Complications include pancreatitis, perforation, bleeding

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

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.

The statistical analysis plan, study design and information on main outcomes will be shared

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corresponding author َAmir Sadeghi amirsadeghimd@yahoo.com

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