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Pancreatic Duct Stent for Acute Necrotizing Pancreatitis

Primary Purpose

Necrotizing Pancreatitis, Walled Off Necrosis

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Pancreatic Duct Stent Placement

No Pancreatic Duct Stent Placement

About this trial

This is an interventional treatment trial for Necrotizing Pancreatitis

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Center for Interventional Endoscopy - Florida Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Pancreatic Duct Stent Placement

No Pancreatic Duct Stent Placement

Arm Description

Subject will have placement of either the Advanix or Cook Pancreatic Stent placed.

Subject will not have a pancreatic Duct stent placed.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Rates of WON Intervention

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

Rates of DPDS

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

Number of patients with Adverse events

Incidence of procedure related adverse events

Rates of additional interventions resulting from complications

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

Number of patients with Acute pancreatitis

Clinical adverse events related to underlying acute pancreatitis

Number of patients with Local complications

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

Number of patients with Systemic complications

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

Length of stay

Duration of hospitalization in days

Cost

Total hospital costs in US Dollars

Full Information

NCT ID

NCT03115918

First Posted

January 17, 2017

Last Updated

February 15, 2022

Sponsor

AdventHealth

1. Study Identification

Unique Protocol Identification Number

NCT03115918

Brief Title

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

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

August 4, 2016 (Actual)

Primary Completion Date

July 2020 (Actual)

Study Completion Date

November 3, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AdventHealth

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Necrotizing Pancreatitis, Walled Off Necrosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pancreatic Duct Stent Placement

Arm Type

Active Comparator

Arm Description

Subject will have placement of either the Advanix or Cook Pancreatic Stent placed.

Arm Title

No Pancreatic Duct Stent Placement

Arm Type

Active Comparator

Arm Description

Subject will not have a pancreatic Duct stent placed.

Intervention Type

Device

Intervention Name(s)

Pancreatic Duct Stent Placement

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

No Pancreatic Duct Stent Placement

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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 Outcome Measure Information:

Title

Rates of WON Intervention

Description

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

Time Frame

6 weeks

Title

Rates of DPDS

Description

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

Time Frame

6 weeks

Title

Number of patients with Adverse events

Description

Incidence of procedure related adverse events

Time Frame

6 weeks

Title

Rates of additional interventions resulting from complications

Description

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

Time Frame

6 weeks

Title

Number of patients with Acute pancreatitis

Description

Clinical adverse events related to underlying acute pancreatitis

Time Frame

6 weeks

Title

Number of patients with Local complications

Description

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

Time Frame

6 weeks

Title

Number of patients with Systemic complications

Description

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

Time Frame

6 weeks

Title

Length of stay

Description

Duration of hospitalization in days

Time Frame

6 weeks

Title

Cost

Description

Total hospital costs in US Dollars

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shyam Varadarajulu, MD

Organizational Affiliation

AdventHealth

Official's Role

Principal Investigator

Facility Information:

Facility Name

Center for Interventional Endoscopy - Florida Hospital

City

Orlando

State/Province

Florida

ZIP/Postal Code

32803

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

No plan to share individual participant data.

Citations:

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Pancreatic Duct Stent for Acute Necrotizing Pancreatitis

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