The planned multicenter randomized study is aimed to assess the efficacy and safety of endoscopic pancreatic duct stenting in adult patients with acute pancreatitis. It is planned to include patients with early-stage nonbiliary pancreatitis in the study.
Diagnosis of acute pancreatitis confirmed on the basis of at least 2 of the 3 diagnostic criteria according to the revised Atlanta classification
Presence of organ failure signs (moderate and severe pancreatitis)
Informed consent of the patient
Presence of other indications for endoscopic intervention on the major duodenal papilla (biliary pancreatitis with cholangitis, calculus of the major duodenal papilla, stenosis of the major duodenal papilla, etc.)
Previous surgical interventions on the major duodenal papilla
Diverticula of the major duodenal papilla
Pregnancy
Parallel
Endoscopic pancreatic duct stent placement
Procedure/SurgeryEndoscopic pancreatic duct stent placement will be performed with a 5Fr Boston Scientific pancreatic stent (3-4 cm in length) within 24 hours from the randomization procedure. The stent will be removed on the 5th day after installation.
Conventional treatment of acute pancreatitis in early phase
DrugInfusion therapy, pain relief, nutritional support and surgical procedure if needed
Mortality rate
Data will be tabulated and statistically analyzed in terms of percentages
Incidence of complications associated with endoscopic pancreatic duct stent placement
Frequency of duodenal bleeding, duodenal perforation, unsuccessful major duodenal papilla canulation etc. Data will be tabulated and statistically analyzed in terms of percentages
Rate of different pancreatic necrosis models
Will be evaluated according CT-imaging: Model 1 - volume of pancreatic necrosis \< 30%, or not determined Model 2 - volume of pancreatic necrosis 30-50%, located in the distal pancreatic part Model 3 - volume of pancreatic necrosis 30-50% located in the proximal part Model 4 - volume of pancreatic necrosis 30-50% and more with separation of viable proximal and distal parts (disconnected duct syndrome) Data will be tabulated and statistically analyzed in terms of percentages
Average Balthazar computed tomography severity index (0-10)
A scoring system used to assess the severity of acute pancreatitis based on computed tomography scans. Data will be tabulated and statistically analyzed in terms of mean.
Average SOFA (Sequential Organ Failure Assessment Score) score (0-24)
Sequential Organ Failure Assessment Score. Data will be tabulated and statistically analyzed in terms of mean
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