Clinical trial NCT03115918: Pancreatic Duct Stent for Acute Necrotizing Pancreatitis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Necrotizing Pancreatitis
Walled Off Necrosis
Lead sponsor: AdventHealth
Sponsor class: OTHER
First posted: 2017-04-14
Enrollment: 1
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 19 years
2. The subject (or when applicable the subject's LAR) is capable of understanding and complying with protocol requirements.
3. The subject (or when applicable the subject's LAR) is able to understand and willing to sign an informed consent form prior to the initiation of any study procedures.
4. All patients with acute necrotizing pancreatitis and bedside index for severity in acute pancreatitis (BISAP) score of ≥ 3, who have been referred to Florida Hospital for Percutaneous endoscopy gastrojeunostomy (PEG-J) tube placement and/or ERCP for assessment of the PD
5. Absence of pancreatic fluid collection (defined as those \> 3cm in size located along the course of the main PD on cross-sectional imaging) at the time of study enrollment
6. No disconnected pancreatic duct syndrome (DPDS) on cross-sectional imaging or ERCP

Exclusion Criteria:

1. Age \<19 years
2. Unable to obtain consent for the procedure from either the patient or LAR
3. Patients with acute interstitial pancreatitis, without pancreatic necrosis
4. Patients with BISAP score ≤ 2
5. Patients with pancreatic fluid collection \> 3cm in size located along the course of the main PD on cross-sectional imaging prior to the initial ERCP
6. Patients with DPDS on cross-sectional imaging or ERCP
7. Unable to safely undergo ERCP for any reason
8. Failed cannulation during ERCP

Primary outcomes:
measure: Incidence of WON between the PD stent and no PD stent groups
timeFrame: 4-6 weeks post-index ERCP
Secondary outcomes:
measure: Rates of WON Intervention
timeFrame: 6 weeks
measure: Rates of DPDS
timeFrame: 6 weeks
measure: Number of patients with Adverse events
timeFrame: 6 weeks
measure: Rates of additional interventions resulting from complications
timeFrame: 6 weeks
measure: Number of patients with Acute pancreatitis
timeFrame: 6 weeks
measure: Number of patients with Local complications
timeFrame: 6 weeks
measure: Number of patients with Systemic complications
timeFrame: 6 weeks
measure: Length of stay
timeFrame: 6 weeks
measure: Cost
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Center for Interventional Endoscopy - Florida Hospital
state: Florida
Study officials:
affiliation: AdventHealth
name: Shyam Varadarajulu, MD
role: PRINCIPAL_INVESTIGATOR
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