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.
Endoscopic pancreatic duct stent placement is used to treat a variety of pancreatic diseases, including chronic pancreatitis, Wirsung duct strictures, pseudocysts in disconnected duct syndrome and as a preventive measure after endoscopic retrograde cholangiopancreatography. Despite the obvious progress, the greatest number of unsolved problems remain in the issues of using this manipulation in patients with acute pancreatitis. In particular, the perspectives of the pancreatic duct stent placement in treatment of acute pancreatitis early stages remain controversial. On the one hand, the installation of a stent in the early acute pancreatitis stages helps to normalize the outflow of pancreatic juice from the pancreas and reduce intraductal pressure, leading to a beneficial effect, as evidenced by a number of researchers. On the other hand, stent placement may partially block the second-order pancreatic ducts or increase the risk of sterile pancreatitis contamination due to the development of reflux. In addition, one should not forget about a number of post-manipulation complications inherent in this procedure, including bleeding from the area of the major duodenal papilla, perforation of the duodenum, progression of pancreatic necrosis and cholangitis. Finally, the timing and indications for early endoscopic stenting of the pancreatic duct are not currently standardized, largely due to the fact that acute pancreatitis is a pathological condition that is difficult to predict. Thus, although this manipulation seems perspective, due to the lack of evidence base, it is currently difficult to recommend it for use in wide clinical practice. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Endoscopic 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.
Infusion therapy, pain relief, nutritional support and surgical procedure if needed
Department of General Surgery, Sir Run Run Shaw Hospital
Hangzhou, China
City Clinical Hospital No. 4
Perm, Russia
Almazov National Medical Research Centre
Saint Petersburg, Russia
The City Hospital of the Holy Martyr Elizabeth
Saint Petersburg, Russia
I.I. Dzhanelidze research institute of emergency medicine
Saint Petersburg, Russia
Mariinskaya Hospital
Saint Petersburg, Russia
Volgograd State Medical University
Volgograd, Russia
Mortality rate
Data will be tabulated and statistically analyzed in terms of percentages
Time frame: From enrollment to the end of treatment at 3 months
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
Time frame: From endoscopic pancreatic duct stent placement to 3 months
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
Time frame: From enrollment to the 7th day of treatment
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.
Time frame: From enrollment to the 7th day of treatment
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
Time frame: From enrollment to the 7th day of treatment
Incidence of other surgical interventions
Frequency of other surgical interventions, such as abdominal drainage, retroperitoneal drainage, lumbotomy, laparotomy. Data will be tabulated and statistically analyzed in terms of percentages
Time frame: From enrollment to the end of treatment at 3 months
Number of participants with other surgical interventions
Number of other surgical interventions, such as abdominal drainage, retroperitoneal drainage, lumbotomy, laparotomy
Time frame: From enrollment to the end of treatment at 3 months
Length of hospital stay
Data will be tabulated and statistically analyzed in terms of length of hospital stay in days
Time frame: From date of hospitalization until the date of discharge, assessed up to 3 months
Number of participants with manifestation of diabetes mellitus
Data will be tabulated and statistically analyzed in terms of percentages
Time frame: From enrollment to the end of treatment at 3 months
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