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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 : June 1, 2018
Sponsor:
Information provided by (Responsible Party):
Florida Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Necrotizing Pancreatitis Walled Off Necrosis Device: Pancreatic Duct Stent Placement Other: No Pancreatic Duct Stent Placement Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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

Locations
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   
Sponsors and Collaborators
Florida Hospital
Investigators
Principal Investigator: Shyam Varadarajulu, MD Florida Hospital
More Information
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Publications:

Responsible Party: Florida Hospital
ClinicalTrials.gov Identifier: NCT03115918     History of Changes
Other Study ID Numbers: 922733
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: June 1, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share individual participant data.

Additional relevant MeSH terms:
Pancreatitis
Necrosis
Pancreatitis, Acute Necrotizing
 Pancreatic Diseases
Digestive System Diseases
Pathologic Processes