Pancreatic Duct Stent for Acute Necrotizing Pancreatitis

Necrotizing Pancreatitis Clinical Trial

Official title: Randomized Trial Examining the Impact of Pancreatic Duct Stent Placement in Patients With Acute Necrotizing Pancreatitis in the Prevention of Walled-off Necrosis

Status Completed

Clinical Trial Summary

The research design is a randomized prospective clinical study comparing the incidence of Walled Off Necrosis (WON) in patients with acute necrotizing pancreatitis.

Clinical Trial Description

This is a randomized trial comparing the incidence of WON in patients with acute necrotizing pancreatitis, according to the placement or non-placement of an Advanix or a Cook Pancreatic Duct (PD) stent during Endoscopic Retrograde Cholangiopancreatography (ERCP) within 1-2 week of symptom onset. Patients will be randomly allocated to either treatment arm i.e. to either PD stent placement or no PD placement in a 1:1 ratio. The type of stent to be placed is at the discretion of the physician based on the clinical needs and presentation of the patient at the time of procedure. This is based on factors such as the size of the WON, the patient's anatomy, and other variables. Patients will be assessed at 4-6 weeks post-ERCP for the primary outcome measure, which is the incidence of WON on contrast-enhanced CT. ;

Related Conditions & MeSH terms

• Necrosis
• Necrotizing Pancreatitis
• Pancreatitis
• Pancreatitis, Acute Necrotizing
• Walled Off Necrosis

• NCT number: NCT03115918
• Study type: Interventional
• Source: AdventHealth
• Status: Completed
• Phase: N/A
• Start date: August 4, 2016
• Completion date: November 3, 2020