Comparison of FCSEMS and Plastic Stents (WON-MVP)

February 8, 2019 updated by: AdventHealth

Randomized Trial Comparing Fully Covered, Self-Expanding Metal Stent and Plastic Stents for Endoscopic Ultrasound-guided Drainage of Walled-off Necrosis

The research design is a randomized prospective clinical trial comparing Endoscopic ultrasound (EUS) guided drainage of WON using FCSEMS and plastic stents. The trial will be conducted at the Florida Hospital Center for Interventional Endoscopy, Orlando, Florida.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The research design is a randomized prospective clinical trial comparing EUS-guided drainage of WON using FCSEMS and plastic stents. The trial will be conducted at the Florida Hospital Center for Interventional Endoscopy, Orlando, Florida.The sample size estimated for this study is 60 patients. All patients will undergo EUS-guided drainage of WON and be randomized to either FCSEM or plastic stents in a 1:1 ratio using a computer-generated randomized sequence. It will not be possible to blind the endoscopist to the stent type being inserted due to the differences in stent appearance. The statistician will be blinded to the stent type utilized.

Study Type

Interventional

Enrollment (Actual)

60

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

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. The subject (or when applicable the subject's LAR) is capable of understanding and complying with protocol requirements.
  2. 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.
  3. Males or females ≥ 18 years of age.
  4. WON diagnosed on contrast-enhanced dual phase CT abdomen/pelvis (CECT) or MRI with gadolinium (seen as a fluid collection in the setting of documented pancreatic necrosis that contains necrotic material and encased within a well-defined tissue layer).
  5. WON of any size with any quantity of solid/necrotic component and any no. of loculations, located within the pancreatic/peri-pancreatic space not requiring percutaneous drainage, within 2cm of the enteric wall
  6. Suspected/confirmed infected WON (defined as temp ≥ 100.5°F, serum White Blood Cells ≥ 15x109/L, positive blood cultures or positive Gram stain/culture of aspirated necrotic material), and/or symptomatic WON (defined as abdominal pain, gastric/intestinal/biliary outlet obstruction resulting in nausea, vomiting, early satiety, jaundice, or persistent malaise) ≥ 4 weeks from attack of acute pancreatitis.

  7. Documented history of acute or chronic pancreatitis:

    i. Acute pancreatitis is diagnosed if 2 of the following 3 criteria are met:

    1. Abdominal pain characteristic of acute pancreatitis
    2. Serum lipase/amylase ≥ x3 upper limit of normal
    3. Characteristic radiological findings of acute pancreatitis on CECT/MRI/US abdomen, such as homogeneous enhancement of pancreatic parenchyma, standing of peripancreatic fat ii. Chronic pancreatitis is diagnosed if characteristic radiological changes are seen on CT/MRI with Magnetic resonance cholangiopancreatography (MRCP) (such as pancreatic atrophy, dilated pancreatic duct, pancreatic calcification) or EUS (≥5/9 of Rosement criteria)
  8. Able to undergo general anesthesia

Exclusion Criteria:

  1. Females who are pregnant or lactating. Pregnancy for females of childbearing potential will be determined by routine preoperative urine or serum Human Chorionic Gonadotropin testing.
  2. Irreversible coagulopathy (INR >1.5, thrombocytopenia with platelet count <50,000/mL)
  3. Has surgically altered gastrointestinal anatomy such as but not limited to Billroth II, Roux-en-Y, gastric bypass
  4. Age < 18 years
  5. Unable to obtain consent for the procedure from either the patient or LAR
  6. Use of anticoagulants that cannot be discontinued for the procedure
  7. Unable to tolerate general anesthesia
  8. WON that is not accessible for EUS-guided drainage
  9. Percutaneous drainage of WON is required or performed prior to EUS-guided drainage

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: FCSEM Stent
WON is first identified using EUS and punctured using a 19 gauge needle. 10 ml of fluid is aspirated and sent for gram stain and culture with sensitivities. Using a catheter-based stent delivery system with a 15mm AXIOS stent mounted onto it is inserted into the echoendoscope, and introduced into the WON cavity so that the stent lies within both the WON and enteric lumen. The stent is then deployed so that one flange of the stent is located within the WON cavity and the other flange is located within the enteric lumen.
Device: FCSEM Stent
Hot Axios Fully covered self-expandable metal stent - Boston Scientific
Other Names:
  • Fully covered self-expandable metal stent
Active Comparator: Plastic Stents
WON is first identified using EUS, and punctured using a 19 gauge needle. 10 ml of the WON fluid is aspirated and sent for gram stain and culture with sensitivities. A 0.025 or 0.035 inch guidewire is inserted into the WON through the fine needle aspiration (FNA) needle. A transmural tract is created using an Endoscopic Retrograde Cholangiopancreatography(ERCP) catheter (with the use of a needle knife catheter ± cautery if needed), and then dilated using a 12-13.5-15mm Controlled Radial Expansion (CRE) balloon to a maximum size of 15mm if technically possible. Two or three 7 French plastic stents are inserted through the transmural tract into the WON cavity.
Device: Plastic Stent
7 French 4 cm double pigtail plastic stent - Cook 7 French 4 cm double pigtail plastic stent - Boston Scientific

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of interventions performed between metal and plastic stent groups to achieve treatment success
Time Frame: 6 weeks
The primary objective of this study is to compare the number of interventions performed between metal and plastic stent groups to achieve treatment success at 6 week follow-up. Re-intervention is defined as the need for repeat EUS-guided drainage of WON using the same stent type and/or DEN and/or insertion of percutaneous catheter due to inadequate treatment response following initial WON drainage. As FCSEMS have larger diameter than plastic stents, the investigators hypothesize that the no. of re-interventions performed will be lower in the FCSEMS group compared to the plastic stent group.
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical success
Time Frame: at index treatment Day 0
Successful deployment of transmural stents in to the WON cavity.
at index treatment Day 0
Treatment success
Time Frame: 6 week
Resolution of WON on CT scan and resolution of symptoms at 6-week outpatient follow-up (from day of hospital discharge) WITHOUT the need for cross-over to minimally invasive surgical debridement
6 week
Treatment failure
Time Frame: 6 months
Need for minimally-invasive surgical debridement as a consequence of inadequate endoscopic treatment response, or death as a direct consequence of WON drainage or underlying diseaseor underlying disease.
6 months
Recurrence
Time Frame: 6 months
Development of WON or additional Pancreatic Fluid Collection and recurrence of symptoms following initial treatment success
6 months
Procedure duration (minutes)
Time Frame: at index treatment Day 0
Time from start of the procedure (endoscope inserted into the gastrointestinal lumen to perform transmural drainage to the end of the procedure (removal of the echoendoscope/ gastroscope/ duodenoscope from the oropharynx).
at index treatment Day 0
Adverse events
Time Frame: 6 months
Adverse event directly resulting from performing endoscopic drainage procedure. The severity will be graded according to a previously published consensus.
6 months
Duration of hospitalization
Time Frame: 6 months
Day of procedure to the day of hospital discharge
6 months
Cost Analysis (Inpatient and outpatient costs)
Time Frame: 6 months
Inpatient and outpatient costs of care will be calculated based on Medicare reimbursement fee structure.
6 months

Collaborators and Investigators

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

Sponsor

AdventHealth

Investigators

  • Principal Investigator: Shyam Varadarajulu, MD, Florida Hospital Orlando

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)

February 12, 2016

Primary Completion (Actual)

July 10, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

November 24, 2015

First Submitted That Met QC Criteria

February 18, 2016

First Posted (Estimate)

February 19, 2016

Study Record Updates

Last Update Posted (Actual)

February 11, 2019

Last Update Submitted That Met QC Criteria

February 8, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 837579

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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.

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