NCT03115918

Pancreatic Duct Stent for Acute Necrotizing Pancreatitis

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: AdventHealth · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Necrotizing Pancreatitis
• Walled Off Necrosis

Interventions

Type	Name	Description
DEVICE	Pancreatic Duct Stent Placement	Patients will be randomly allocated to either treatment arm to have a PD stent placed.
OTHER	No Pancreatic Duct Stent Placement	Patients will be randomly allocated to either treatment arm and not receive PD placement.

Timeline

• Start date: 2016-08-04
• Primary completion: 2020-07-01
• Completion: 2020-11-03
• First posted: 2017-04-14
• Last updated: 2022-02-17

Locations

1 site across 1 country: United States