Pancreatic Duct Stent for Acute Necrotizing Pancreatitis

AdventHealth1 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Necrotizing Pancreatitis Walled Off Necrosis

Interventions

Pancreatic Duct Stent PlacementDEVICE

Patients will be randomly allocated to either treatment arm to have a PD stent placed.

No Pancreatic Duct Stent PlacementOTHER

Patients will be randomly allocated to either treatment arm and not receive PD placement.

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

Center for Interventional Endoscopy - Florida Hospital

Orlando, Florida, United States

Outcomes

Primary Outcomes

Incidence of WON between the PD stent and no PD stent groups

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.

Time frame: 4-6 weeks post-index ERCP

Secondary Outcomes

Rates of WON Intervention

Incidence of WON requiring intervention of any type (including endoscopic, surgical or interventional radiology interventions)

Time frame: 6 weeks

Rates of DPDS

Incidence of DPDS, as determined by ERCP or Magnetic Resonance Cholangiopancreatography (MRCP)

Time frame: 6 weeks

Number of patients with Adverse events

Incidence of procedure related adverse events

Time frame: 6 weeks

Rates of additional interventions resulting from complications

Incidence of other interventions undertaken as clinically indicated for complications of acute pancreatitis

Time frame: 6 weeks

Number of patients with Acute pancreatitis

Clinical adverse events related to underlying acute pancreatitis

Time frame: 6 weeks

Number of patients with Local complications

Clinical adverse events arising as a result of local complications of acute pancreatitis

Time frame: 6 weeks

Number of patients with Systemic complications

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.