Pancreatic Duct Stent for Acute Necrotizing Pancreatitis

February 15, 2022 updated by: AdventHealth

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States, 32803
        • Center for Interventional Endoscopy - Florida Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4-6 weeks post-index ERCP

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rates of WON Intervention
Time Frame: 6 weeks
Incidence of WON requiring intervention of any type (including endoscopic, surgical or interventional radiology interventions)
6 weeks
Rates of DPDS
Time Frame: 6 weeks
Incidence of DPDS, as determined by ERCP or Magnetic Resonance Cholangiopancreatography (MRCP)
6 weeks
Number of patients with Adverse events
Time Frame: 6 weeks
Incidence of procedure related adverse events
6 weeks
Rates of additional interventions resulting from complications
Time Frame: 6 weeks
Incidence of other interventions undertaken as clinically indicated for complications of acute pancreatitis
6 weeks
Number of patients with Acute pancreatitis
Time Frame: 6 weeks
Clinical adverse events related to underlying acute pancreatitis
6 weeks
Number of patients with Local complications
Time Frame: 6 weeks
Clinical adverse events arising as a result of local complications of acute pancreatitis
6 weeks
Number of patients with Systemic complications
Time Frame: 6 weeks
Clinical adverse events arising as a result of systemic complications of acute pancreatitis
6 weeks
Length of stay
Time Frame: 6 weeks
Duration of hospitalization in days
6 weeks
Cost
Time Frame: 6 weeks
Total hospital costs in US Dollars
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AdventHealth

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 4, 2016

Primary Completion (Actual)

July 1, 2020

Study Completion (Actual)

November 3, 2020

Study Registration Dates

First Submitted

January 17, 2017

First Submitted That Met QC Criteria

April 11, 2017

First Posted (Actual)

April 14, 2017

Study Record Updates

Last Update Posted (Actual)

February 17, 2022

Last Update Submitted That Met QC Criteria

February 15, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 922733

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan to share individual participant data.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Walled Off Necrosis

Clinical Trials on Pancreatic Duct Stent Placement

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Colombia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe