Clinical Trial: Pancreatic Duct Stent for Acute Necrotizing Pancreatitis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief 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 Summary: 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.
Sponsor: Florida Hospital

Current Primary Outcome: Incidence of WON between the PD stent and no PD stent groups [ Time Frame: 4-6 weeks post-index ERCP ]

The primary aim of the study is to compare the incidence of WON between the PD stent and no PD stent groups at 4-6 weeks post-index ERCP.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Rates of WON Intervention [ Time Frame: 6 weeks ]
    Incidence of WON requiring intervention of any type (including endoscopic, surgical or interventional radiology interventions)
  • Rates of DPDS [ Time Frame: 6 weeks ]
    Incidence of DPDS, as determined by ERCP or Magnetic Resonance Cholangiopancreatography (MRCP)
  • Number of patients with Adverse events [ Time Frame: 6 weeks ]
    Incidence of procedure related adverse events
  • Rates of additional interventions resulting from complications [ Time Frame: 6 weeks ]
    Incidence of other interventions undertaken as clinically indicated for complications of acute pancreatitis
  • Number of patients with Acute pancreatitis [ Time Frame: 6 weeks ]
    Clinical adverse events related to underlying acute pancreatitis
  • Number of patients with Local complications [ Time Frame: 6 weeks ]
    Clinical adverse events arising as a result of local complications of acute pancreatitis
  • Number of patients with Systemic complications [ Time Frame: 6 weeks ]
    Clinical adverse events arising as a result of systemic complications of acute pancreatitis
  • Length of stay [ Time Frame: 6 weeks ]
    Duration of hospitalization in days
  • Cost [ Time Frame: 6 weeks ]
    Total hospital costs in US Dollars


Original Secondary Outcome: Same as current

Information By: Florida Hospital

Dates:
Date Received: January 17, 2017
Date Started: August 2016
Date Completion: December 2018
Last Updated: April 11, 2017
Last Verified: April 2017