Acute Pancreatitis (AP)
Conditions
Keywords
acute pancreatitis, endoscopic pancreatic duct stent placement, pancreatic necrosis
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREEndoscopic pancreatic duct stent placement
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.
DRUGConventional treatment of acute pancreatitis in early phase
Infusion therapy, pain relief, nutritional support and surgical procedure if needed
Sponsors
Almazov National Medical Research Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized controlled trial Masking: not provided (open allocation). Given the specific nature of the medical discipline being studied, blinding of participants, as well as allocation concealment, is not planned due to the practical impossibility of this procedures. Randomization method: calendar, according to which patients born in an even year will be distributed into the study group, and those born in an odd year - into the comparison group.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of acute pancreatitis confirmed on the basis of at least 2 of the 3 diagnostic criteria according to the revised Atlanta classification 2. Presence of organ failure signs (moderate and severe pancreatitis) 3. Informed consent of the patient
Exclusion criteria
1. 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.) 2. Previous surgical interventions on the major duodenal papilla 3. Diverticula of the major duodenal papilla 4. Pregnancy 5. Shock 6. Coagulopathy (INR\>1.5, blood platelets \< 50\*109/l
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality rate | From enrollment to the end of treatment at 3 months | Data will be tabulated and statistically analyzed in terms of percentages |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of different pancreatic necrosis models | From enrollment to the 7th day of treatment | 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) | From enrollment to the 7th day of treatment | 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) | From enrollment to the 7th day of treatment | Sequential Organ Failure Assessment Score. Data will be tabulated and statistically analyzed in terms of mean |
| Incidence of complications associated with endoscopic pancreatic duct stent placement | From endoscopic pancreatic duct stent placement to 3 months | Frequency of duodenal bleeding, duodenal perforation, unsuccessful major duodenal papilla canulation etc. Data will be tabulated and statistically analyzed in terms of percentages |
| Number of participants with other surgical interventions | From enrollment to the end of treatment at 3 months | Number of other surgical interventions, such as abdominal drainage, retroperitoneal drainage, lumbotomy, laparotomy |
| Length of hospital stay | From date of hospitalization until the date of discharge, assessed up to 3 months | Data will be tabulated and statistically analyzed in terms of length of hospital stay in days |
| Number of participants with manifestation of diabetes mellitus | From enrollment to the end of treatment at 3 months | Data will be tabulated and statistically analyzed in terms of percentages |
| Incidence of other surgical interventions | From enrollment to the end of treatment at 3 months | Frequency of other surgical interventions, such as abdominal drainage, retroperitoneal drainage, lumbotomy, laparotomy. Data will be tabulated and statistically analyzed in terms of percentages |
Countries
China, Russia
Contacts
Primary ContactPavel A Kotkov, MD
Backup ContactBadri V Sigua, PhD
Outcome results
None listed