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NCT Number: NCT03115918

Pancreatic Duct Stent for Acute Necrotizing Pancreatitis

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

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Key information

Conditions

Necrotizing Pancreatitis Digestive System Diseases Pancreatic Diseases Pancreatitis Pancreatitis, Acute Necrotizing Walled Off Necrosis

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Interventional Endoscopy - Florida Hospital

Orlando, Florida, 32803, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 19 years
  • The subject (or when applicable the subject's LAR) is capable of understanding and complying with protocol requirements.
  • 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.
  • 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
  • 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
  • No disconnected pancreatic duct syndrome (DPDS) on cross-sectional imaging or ERCP

Exclusion criteria

  • Age <19 years
  • Unable to obtain consent for the procedure from either the patient or LAR
  • Patients with acute interstitial pancreatitis, without pancreatic necrosis
  • Patients with BISAP score ≤ 2
  • 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
  • Patients with DPDS on cross-sectional imaging or ERCP
  • Unable to safely undergo ERCP for any reason
  • Failed cannulation during ERCP

Treatment and study plan

Pancreatic Duct Stent Placement

Device

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

No Pancreatic Duct Stent Placement

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Rates of WON Intervention

    Time frame: 6 weeks

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

  2. Rates of DPDS

    Time frame: 6 weeks

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

  3. Number of patients with Adverse events

    Time frame: 6 weeks

    Incidence of procedure related adverse events

  4. Rates of additional interventions resulting from complications

    Time frame: 6 weeks

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

  5. Number of patients with Acute pancreatitis

    Time frame: 6 weeks

    Clinical adverse events related to underlying acute pancreatitis

  6. Number of patients with Local complications

    Time frame: 6 weeks

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

  7. Number of patients with Systemic complications

    Time frame: 6 weeks

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

  8. Length of stay

    Time frame: 6 weeks

    Duration of hospitalization in days

  9. Cost

    Time frame: 6 weeks

    Total hospital costs in US Dollars

Sponsors and collaborators

Lead sponsor

AdventHealth

Other

Registry information

Official study title

Randomized Trial Examining the Impact of Pancreatic Duct Stent Placement in Patients With Acute Necrotizing Pancreatitis in the Prevention of Walled-off Necrosis

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Apr 14, 2017
Registry last updated
Feb 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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