NCT07093996

Endoscopic Pancreatic Duct Stent Placement Versus Conventional Approach in the Treatment of Early Phase Acute Pancreatitis

Endoscopic Pancreatic Duct Stent Placement Versus Conventional Approach in the Treatment of Early Phase Acute Pancreatitis: International Multicenter Controlled Randomized Prospective Study Protocol

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Almazov National Medical Research Centre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Pancreatitis (AP)

Interventions

Type	Name	Description
PROCEDURE	Endoscopic 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.
DRUG	Conventional treatment of acute pancreatitis in early phase	Infusion therapy, pain relief, nutritional support and surgical procedure if needed

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-12-01
• Completion: 2027-02-01
• First posted: 2025-07-30
• Last updated: 2025-07-30

Locations

7 sites across 2 countries: China, Russia