Pancreatic Duct Stent for Acute Necrotizing Pancreatitis
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|ClinicalTrials.gov Identifier: NCT03115918|
Recruitment Status : Recruiting
First Posted : April 14, 2017
Last Update Posted : July 16, 2020
|Condition or disease||Intervention/treatment||Phase|
|Necrotizing Pancreatitis Walled Off Necrosis||Device: Pancreatic Duct Stent Placement Other: No Pancreatic Duct Stent Placement||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||28 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Study Start Date :||August 2016|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||December 2020|
Active Comparator: Pancreatic Duct Stent Placement
Subject will have placement of either the Advanix or Cook Pancreatic Stent placed.
Device: Pancreatic Duct Stent Placement
Patients will be randomly allocated to either treatment arm to have a PD stent placed.
Active Comparator: No Pancreatic Duct Stent Placement
Subject will not have a pancreatic Duct stent placed.
Other: No Pancreatic Duct Stent Placement
Patients will be randomly allocated to either treatment arm and not receive PD placement.
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03115918
|Contact: Shyam Varadarajulu, MD||407.303.2750||Shyam.Varadarajulu.MD@flhosp.org|
|Contact: Robin Barron-Nelson, RN, MSN||407.303.5503||Robin.Barron@flhosp.org|
|United States, Florida|
|Center for Interventional Endoscopy - Florida Hospital||Recruiting|
|Orlando, Florida, United States, 32803|
|Contact: Shyam Varadarajulu, MD 407-303-2750 Shyam.Varadarajulu.MD@flhosp.org|
|Contact: Robin E Barron-Nelson, RN, MSN 407.303.5503 Robin.Barron@flhosp.org|
|Principal Investigator:||Shyam Varadarajulu, MD||AdventHealth|